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Alternative medicine – Wikipedia

Alternative medicineAM, complementary and alternative medicine (CAM), complementary medicine, heterodox medicine, integrative medicine (IM), complementary and integrative medicine (CIM), new-age medicine, unconventional medicine, unorthodox medicineHow alternative treatments “work”:a) Misinterpreted natural course the individual gets better without treatment.b) Placebo effect or false treatment effect an individual receives “alternative therapy” and is convinced it will help. The conviction makes them more likely to get better.c) Nocebo effect an individual is convinced that standard treatment will not work, and that alternative treatment will work. This decreases the likelihood standard treatment will work, while the placebo effect of the “alternative” remains. d) No adverse effects Standard treatment is replaced with “alternative” treatment, getting rid of adverse effects, but also of improvement. e) Interference Standard treatment is “complemented” with something that interferes with its effect. This can both cause worse effect, but also decreased (or even increased) side effects, which may be interpreted as “helping”.Researchers such as epidemiologists, clinical statisticians and pharmacologists use clinical trials to tease out such effects, allowing doctors to offer only that which has been shown to work. “Alternative treatments” often refuse to use trials or make it deliberately hard to do so.

Alternative medicine, fringe medicine, pseudomedicine or simply questionable medicine is the use and promotion of practices which are unproven, disproven, impossible to prove, or excessively harmful in relation to their effect in the attempt to achieve the healing effects of medicine. They differ from experimental medicine in that the latter employs responsible investigation, and accepts results that show it to be ineffective. The scientific consensus is that alternative therapies either do not, or cannot, work. In some cases laws of nature are violated by their basic claims; in some the treatment is so much worse that its use is unethical. Alternative practices, products, and therapies range from only ineffective to having known harmful and toxic effects.

Alternative therapies may be credited for perceived improvement through placebo effects, decreased use or effect of medical treatment (and therefore either decreased side effects; or nocebo effects towards standard treatment), or the natural course of the condition or disease. Alternative treatment is not the same as experimental treatment or traditional medicine, although both can be misused in ways that are alternative. Alternative or complementary medicine is dangerous because it may discourage people from getting the best possible treatment, and may lead to a false understanding of the body and of science.

Alternative medicine is used by a significant number of people, though its popularity is often overstated. Large amounts of funding go to testing alternative medicine, with more than US$2.5 billion spent by the United States government alone. Almost none show any effect beyond that of false treatment, and most studies showing any effect have been statistical flukes. Alternative medicine is a highly profitable industry, with a strong lobby. This fact is often overlooked by media or intentionally kept hidden, with alternative practice being portrayed positively when compared to “big pharma”. The lobby has successfully pushed for alternative therapies to be subject to far less regulation than conventional medicine. Alternative therapies may even be allowed to promote use when there is demonstrably no effect, only a tradition of use. Regulation and licensing of alternative medicine and health care providers varies between and within countries. Despite laws making it illegal to market or promote alternative therapies for use in cancer treatment, many practitioners promote them. Alternative medicine is criticized for taking advantage of the weakest members of society. For example, the United States National Institutes of Health department studying alternative medicine, currently named National Center for Complementary and Integrative Health, was established as the Office of Alternative Medicine and was renamed the National Center for Complementary and Alternative Medicine before obtaining its current name. Therapies are often framed as “natural” or “holistic”, in apparent opposition to conventional medicine which is “artificial” and “narrow in scope”, statements which are intentionally misleading. When used together with functional medical treatment, alternative therapies do not “complement” (improve the effect of, or mitigate the side effects of) treatment. Significant drug interactions caused by alternative therapies may instead negatively impact functional treatment, making it less effective, notably in cancer.

Alternative diagnoses and treatments are not part of medicine, or of science-based curricula in medical schools, nor are they used in any practice based on scientific knowledge or experience. Alternative therapies are often based on religious belief, tradition, superstition, belief in supernatural energies, pseudoscience, errors in reasoning, propaganda, fraud, or lies. Alternative medicine is based on misleading statements, quackery, pseudoscience, antiscience, fraud, and poor scientific methodology. Promoting alternative medicine has been called dangerous and unethical. Testing alternative medicine that has no scientific basis has been called a waste of scarce research resources. Critics state that “there is really no such thing as alternative medicine, just medicine that works and medicine that doesn’t”, that the very idea of “alternative” treatments is paradoxical, as any treatment proven to work is by definition “medicine”.

Alternative medicine is defined loosely as a set of products, practices, and theories that are believed or perceived by their users to have the healing effects of medicine,[n 1][n 2] but whose effectiveness has not been clearly established using scientific methods,[n 1][n 3][4][5][6][7] or whose theory and practice is not part of biomedicine,[n 2][n 4][n 5][n 6] or whose theories or practices are directly contradicted by scientific evidence or scientific principles used in biomedicine.[4][5][11] “Biomedicine” or “medicine” is that part of medical science that applies principles of biology, physiology, molecular biology, biophysics, and other natural sciences to clinical practice, using scientific methods to establish the effectiveness of that practice. Unlike medicine,[n 4] an alternative product or practice does not originate from using scientific methods, but may instead be based on hearsay, religion, tradition, superstition, belief in supernatural energies, pseudoscience, errors in reasoning, propaganda, fraud, or other unscientific sources.[n 3][1][4][5]

In General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine, published in 2000 by the World Health Organization (WHO), complementary and alternative medicine were defined as a broad set of health care practices that are not part of that country’s own tradition and are not integrated into the dominant health care system.[12]

The expression also refers to a diverse range of related and unrelated products, practices, and theories ranging from biologically plausible practices and products and practices with some evidence, to practices and theories that are directly contradicted by basic science or clear evidence, and products that have been conclusively proven to be ineffective or even toxic and harmful.[n 2][14][15]

The terms alternative medicine, complementary medicine, integrative medicine, holistic medicine, natural medicine, unorthodox medicine, fringe medicine, unconventional medicine, and new age medicine are used interchangeably as having the same meaning and are almost synonymous in most contexts.[16][17][18][19]

The meaning of the term “alternative” in the expression “alternative medicine”, is not that it is an effective alternative to medical science, although some alternative medicine promoters may use the loose terminology to give the appearance of effectiveness.[4][20] Loose terminology may also be used to suggest meaning that a dichotomy exists when it does not, e.g., the use of the expressions “western medicine” and “eastern medicine” to suggest that the difference is a cultural difference between the Asiatic east and the European west, rather than that the difference is between evidence-based medicine and treatments that do not work.[4]

Complementary medicine (CM) or integrative medicine (IM) is when alternative medicine is used together with functional medical treatment, in a belief that it improves the effect of treatments.[n 7][1][22][23][24] However, significant drug interactions caused by alternative therapies may instead negatively influence treatment, making treatments less effective, notably cancer therapy.[25][26] Both terms refer to use of alternative medical treatments alongside conventional medicine,[27][28][29] an example of which is use of acupuncture (sticking needles in the body to influence the flow of a supernatural energy), along with using science-based medicine, in the belief that the acupuncture increases the effectiveness or “complements” the science-based medicine.[29]

CAM is an abbreviation of the phrase complementary and alternative medicine.[30][31] It has also been called sCAM or SCAM with the addition of “so-called” or “supplements”.[32][33]

Allopathic medicine or allopathy is an expression commonly used by homeopaths and proponents of other forms of alternative medicine to refer to mainstream medicine. It was used to describe the traditional European practice of heroic medicine,[34] but later continued to be used to describe anything that was not homeopathy.[34]

Allopathy refers to the use of pharmacologically active agents or physical interventions to treat or suppress symptoms or pathophysiologic processes of diseases or conditions.[35] The German version of the word, allopathisch, was coined in 1810 by the creator of homeopathy, Samuel Hahnemann (17551843).[36] The word was coined from allo- (different) and -pathic (relating to a disease or to a method of treatment).[37] In alternative medicine circles the expression “allopathic medicine” is still used to refer to “the broad category of medical practice that is sometimes called Western medicine, biomedicine, evidence-based medicine, or modern medicine” (see the article on scientific medicine).[38]

Use of the term remains common among homeopaths and has spread to other alternative medicine practices. The meaning implied by the label has never been accepted by conventional medicine and is considered pejorative.[39] More recently, some sources have used the term “allopathic”, particularly American sources wishing to distinguish between Doctors of Medicine (MD) and Doctors of Osteopathic Medicine (DO) in the United States.[36][40] William Jarvis, an expert on alternative medicine and public health,[41] states that “although many modern therapies can be construed to conform to an allopathic rationale (e.g., using a laxative to relieve constipation), standard medicine has never paid allegiance to an allopathic principle” and that the label “allopath” was from the start “considered highly derisive by regular medicine”.[42]

Many conventional medical treatments do not fit the nominal definition of allopathy, as they seek to prevent illness, or remove its cause.[43][44]

CAM is an abbreviation of complementary and alternative medicine.[30][31] It has also been called sCAM or SCAM with the addition of “so-called” or “supplements”.[32][33] The words balance and holism are often used, claiming to take into account a “whole” person, in contrast to the supposed reductionism of medicine. Due to its many names the field has been criticized for intense rebranding of what are essentially the same practices: as soon as one name is declared synonymous with quackery, a new name is chosen.[16]

Traditional medicine refers to the pre-scientific practices of a certain culture, contrary to what is typically practiced in other cultures where medical science dominates.

“Eastern medicine” typically refers to the traditional medicines of Asia where conventional bio-medicine penetrated much later.

The words balance and holism are often used alongside complementary or integrative medicine, claiming to take into account a “whole” person, in contrast to the supposed reductionism of medicine. Due to its many names the field has been criticized for intense rebranding of what are essentially the same practices.[16]

Prominent members of the science[45][46] and biomedical science community[3] say that it is not meaningful to define an alternative medicine that is separate from a conventional medicine, that the expressions “conventional medicine”, “alternative medicine”, “complementary medicine”, “integrative medicine”, and “holistic medicine” do not refer to any medicine at all.[45][3][46][47]

Others in both the biomedical and CAM communities say that CAM cannot be precisely defined because of the diversity of theories and practices it includes, and because the boundaries between CAM and biomedicine overlap, are porous, and change. The expression “complementary and alternative medicine” (CAM) resists easy definition because the health systems and practices it refers to are diffuse, and its boundaries poorly defined.[14][n 8] Healthcare practices categorized as alternative may differ in their historical origin, theoretical basis, diagnostic technique, therapeutic practice and in their relationship to the medical mainstream. Some alternative therapies, including traditional Chinese medicine (TCM) and Ayurveda, have antique origins in East or South Asia and are entirely alternative medical systems;[52] others, such as homeopathy and chiropractic, have origins in Europe or the United States and emerged in the eighteenth and nineteenth centuries. Some, such as osteopathy and chiropractic, employ manipulative physical methods of treatment; others, such as meditation and prayer, are based on mind-body interventions. Treatments considered alternative in one location may be considered conventional in another.[55] Thus, chiropractic is not considered alternative in Denmark and likewise osteopathic medicine is no longer thought of as an alternative therapy in the United States.[55]

Critics say the expression is deceptive because it implies there is an effective alternative to science-based medicine, and that complementary is deceptive because it implies that the treatment increases the effectiveness of (complements) science-based medicine, while alternative medicines that have been tested nearly always have no measurable positive effect compared to a placebo.[4][56][57][58]

One common feature of all definitions of alternative medicine is its designation as “other than” conventional medicine. For example, the widely referenced descriptive definition of complementary and alternative medicine devised by the US National Center for Complementary and Integrative Health (NCCIH) of the National Institutes of Health (NIH), states that it is “a group of diverse medical and health care systems, practices, and products that are not generally considered part of conventional medicine”.[61] For conventional medical practitioners, it does not necessarily follow that either it or its practitioners would no longer be considered alternative.[n 9]

Some definitions seek to specify alternative medicine in terms of its social and political marginality to mainstream healthcare.[64] This can refer to the lack of support that alternative therapies receive from the medical establishment and related bodies regarding access to research funding, sympathetic coverage in the medical press, or inclusion in the standard medical curriculum.[64] In 1993, the British Medical Association (BMA), one among many professional organizations who have attempted to define alternative medicine, stated that it[n 10] referred to “…those forms of treatment which are not widely used by the conventional healthcare professions, and the skills of which are not taught as part of the undergraduate curriculum of conventional medical and paramedical healthcare courses”.[65] In a US context, an influential definition coined in 1993 by the Harvard-based physician,[66] David M. Eisenberg,[67] characterized alternative medicine “as interventions neither taught widely in medical schools nor generally available in US hospitals”.[68] These descriptive definitions are inadequate in the present-day when some conventional doctors offer alternative medical treatments and CAM introductory courses or modules can be offered as part of standard undergraduate medical training;[69] alternative medicine is taught in more than 50 per cent of US medical schools and increasingly US health insurers are willing to provide reimbursement for CAM therapies. In 1999, 7.7% of US hospitals reported using some form of CAM therapy; this proportion had risen to 37.7% by 2008.[71]

An expert panel at a conference hosted in 1995 by the US Office for Alternative Medicine (OAM),[72][n 11] devised a theoretical definition[72] of alternative medicine as “a broad domain of healing resources… other than those intrinsic to the politically dominant health system of a particular society or culture in a given historical period”.[74] This definition has been widely adopted by CAM researchers,[72] cited by official government bodies such as the UK Department of Health,[75] attributed as the definition used by the Cochrane Collaboration,[76] and, with some modification,[dubious discuss] was preferred in the 2005 consensus report of the US Institute of Medicine, Complementary and Alternative Medicine in the United States.[n 2]

The 1995 OAM conference definition, an expansion of Eisenberg’s 1993 formulation, is silent regarding questions of the medical effectiveness of alternative therapies.[77] Its proponents hold that it thus avoids relativism about differing forms of medical knowledge and, while it is an essentially political definition, this should not imply that the dominance of mainstream biomedicine is solely due to political forces.[77] According to this definition, alternative and mainstream medicine can only be differentiated with reference to what is “intrinsic to the politically dominant health system of a particular society of culture”.[78] However, there is neither a reliable method to distinguish between cultures and subcultures, nor to attribute them as dominant or subordinate, nor any accepted criteria to determine the dominance of a cultural entity.[78] If the culture of a politically dominant healthcare system is held to be equivalent to the perspectives of those charged with the medical management of leading healthcare institutions and programs, the definition fails to recognize the potential for division either within such an elite or between a healthcare elite and the wider population.[78]

Normative definitions distinguish alternative medicine from the biomedical mainstream in its provision of therapies that are unproven, unvalidated, or ineffective and support of theories with no recognized scientific basis. These definitions characterize practices as constituting alternative medicine when, used independently or in place of evidence-based medicine, they are put forward as having the healing effects of medicine, but are not based on evidence gathered with the scientific method.[1][3][27][28][61][80] Exemplifying this perspective, a 1998 editorial co-authored by Marcia Angell, a former editor of The New England Journal of Medicine, argued that:

It is time for the scientific community to stop giving alternative medicine a free ride. There cannot be two kinds of medicine conventional and alternative. There is only medicine that has been adequately tested and medicine that has not, medicine that works and medicine that may or may not work. Once a treatment has been tested rigorously, it no longer matters whether it was considered alternative at the outset. If it is found to be reasonably safe and effective, it will be accepted. But assertions, speculation, and testimonials do not substitute for evidence. Alternative treatments should be subjected to scientific testing no less rigorous than that required for conventional treatments.[3]

This line of division has been subject to criticism, however, as not all forms of standard medical practice have adequately demonstrated evidence of benefit,[n 4][81] and it is also unlikely in most instances that conventional therapies, if proven to be ineffective, would ever be classified as CAM.[72]

Similarly, the public information website maintained by the National Health and Medical Research Council (NHMRC) of the Commonwealth of Australia uses the acronym “CAM” for a wide range of health care practices, therapies, procedures and devices not within the domain of conventional medicine. In the Australian context this is stated to include acupuncture; aromatherapy; chiropractic; homeopathy; massage; meditation and relaxation therapies; naturopathy; osteopathy; reflexology, traditional Chinese medicine; and the use of vitamin supplements.[83]

The Danish National Board of Health’s “Council for Alternative Medicine” (Sundhedsstyrelsens Rd for Alternativ Behandling (SRAB)), an independent institution under the National Board of Health (Danish: Sundhedsstyrelsen), uses the term “alternative medicine” for:

Proponents of an evidence-base for medicine[n 12][86][87][88][89] such as the Cochrane Collaboration (founded in 1993 and from 2011 providing input for WHO resolutions) take a position that all systematic reviews of treatments, whether “mainstream” or “alternative”, ought to be held to the current standards of scientific method.[90] In a study titled Development and classification of an operational definition of complementary and alternative medicine for the Cochrane Collaboration (2011) it was proposed that indicators that a therapy is accepted include government licensing of practitioners, coverage by health insurance, statements of approval by government agencies, and recommendation as part of a practice guideline; and that if something is currently a standard, accepted therapy, then it is not likely to be widely considered as CAM.[72]

Alternative medicine consists of a wide range of health care practices, products, and therapies. The shared feature is a claim to heal that is not based on the scientific method. Alternative medicine practices are diverse in their foundations and methodologies.[61] Alternative medicine practices may be classified by their cultural origins or by the types of beliefs upon which they are based.[1][4][11][61] Methods may incorporate or be based on traditional medicinal practices of a particular culture, folk knowledge, superstition, spiritual beliefs, belief in supernatural energies (antiscience), pseudoscience, errors in reasoning, propaganda, fraud, new or different concepts of health and disease, and any bases other than being proven by scientific methods.[1][4][5][11] Different cultures may have their own unique traditional or belief based practices developed recently or over thousands of years, and specific practices or entire systems of practices.

Alternative medicine, such as using naturopathy or homeopathy in place of conventional medicine, is based on belief systems not grounded in science.[61]

Alternative medical systems may be based on traditional medicine practices, such as traditional Chinese medicine (TCM), Ayurveda in India, or practices of other cultures around the world.[61] Some useful applications of traditional medicines have been researched and accepted within ordinary medicine, however the underlying belief systems are seldom scientific and are not accepted.

Traditional medicine is considered alternative when it is used outside its home region; or when it is used together with or instead of known functional treatment; or when it can be reasonably expected that the patient or practitioner knows or should know that it will not work such as knowing that the practice is based on superstition.

Since ancient times, in many parts of the world a number of herbs reputed to possess abortifacient properties have been used in folk medicine. Among these are: tansy, pennyroyal, black cohosh, and the now-extinct silphium.[101]:4447, 6263, 15455, 23031 Historian of science Ann Hibner Koblitz has written of the probable protoscientific origins of this folk knowledge in observation of farm animals. Women who knew that grazing on certain plants would cause an animal to abort (with negative economic consequences for the farm) would be likely to try out those plants on themselves in order to avoid an unwanted pregnancy.[102]:120

However, modern users of these plants often lack knowledge of the proper preparation and dosage. The historian of medicine John Riddle has spoken of the “broken chain of knowledge” caused by urbanization and modernization,[101]:167205 and Koblitz has written that “folk knowledge about effective contraception techniques often disappears over time or becomes inextricably mixed with useless or harmful practices.”[102]:vii The ill-informed or indiscriminant use of herbs as abortifacients can cause serious and even lethal side-effects.[103][104]

Bases of belief may include belief in existence of supernatural energies undetected by the science of physics, as in biofields, or in belief in properties of the energies of physics that are inconsistent with the laws of physics, as in energy medicine.[61]

Substance based practices use substances found in nature such as herbs, foods, non-vitamin supplements and megavitamins, animal and fungal products, and minerals, including use of these products in traditional medical practices that may also incorporate other methods.[61][119][120] Examples include healing claims for nonvitamin supplements, fish oil, Omega-3 fatty acid, glucosamine, echinacea, flaxseed oil, and ginseng.[121] Herbal medicine, or phytotherapy, includes not just the use of plant products, but may also include the use of animal and mineral products.[119] It is among the most commercially successful branches of alternative medicine, and includes the tablets, powders and elixirs that are sold as “nutritional supplements”.[119] Only a very small percentage of these have been shown to have any efficacy, and there is little regulation as to standards and safety of their contents.[119] This may include use of known toxic substances, such as use of the poison lead in traditional Chinese medicine.[121]

A US agency, National Center on Complementary and Integrative Health (NCCIH), has created a classification system for branches of complementary and alternative medicine that divides them into five major groups. These groups have some overlap, and distinguish two types of energy medicine: veritable which involves scientifically observable energy (including magnet therapy, colorpuncture and light therapy) and putative, which invokes physically undetectable or unverifiable energy.[125] None of these energies have any evidence to support that they effect the body in any positive or health promoting way.[34]

The history of alternative medicine may refer to the history of a group of diverse medical practices that were collectively promoted as “alternative medicine” beginning in the 1970s, to the collection of individual histories of members of that group, or to the history of western medical practices that were labeled “irregular practices” by the western medical establishment.[4][126][127][128][129] It includes the histories of complementary medicine and of integrative medicine. Before the 1970s, western practitioners that were not part of the increasingly science-based medical establishment were referred to “irregular practitioners”, and were dismissed by the medical establishment as unscientific and as practicing quackery.[126][127] Until the 1970s, irregular practice became increasingly marginalized as quackery and fraud, as western medicine increasingly incorporated scientific methods and discoveries, and had a corresponding increase in success of its treatments.[128] In the 1970s, irregular practices were grouped with traditional practices of nonwestern cultures and with other unproven or disproven practices that were not part of biomedicine, with the entire group collectively marketed and promoted under the single expression “alternative medicine”.[4][126][127][128][130]

Use of alternative medicine in the west began to rise following the counterculture movement of the 1960s, as part of the rising new age movement of the 1970s.[4][131][132] This was due to misleading mass marketing of “alternative medicine” being an effective “alternative” to biomedicine, changing social attitudes about not using chemicals and challenging the establishment and authority of any kind, sensitivity to giving equal measure to beliefs and practices of other cultures (cultural relativism), and growing frustration and desperation by patients about limitations and side effects of science-based medicine.[4][127][128][129][130][132][133] At the same time, in 1975, the American Medical Association, which played the central role in fighting quackery in the United States, abolished its quackery committee and closed down its Department of Investigation.[126]:xxi[133] By the early to mid 1970s the expression “alternative medicine” came into widespread use, and the expression became mass marketed as a collection of “natural” and effective treatment “alternatives” to science-based biomedicine.[4][133][134][135] By 1983, mass marketing of “alternative medicine” was so pervasive that the British Medical Journal (BMJ) pointed to “an apparently endless stream of books, articles, and radio and television programmes urge on the public the virtues of (alternative medicine) treatments ranging from meditation to drilling a hole in the skull to let in more oxygen”.[133]

Mainly as a result of reforms following the Flexner Report of 1910[136] medical education in established medical schools in the US has generally not included alternative medicine as a teaching topic.[n 14] Typically, their teaching is based on current practice and scientific knowledge about: anatomy, physiology, histology, embryology, neuroanatomy, pathology, pharmacology, microbiology and immunology.[138] Medical schools’ teaching includes such topics as doctor-patient communication, ethics, the art of medicine,[139] and engaging in complex clinical reasoning (medical decision-making).[140] Writing in 2002, Snyderman and Weil remarked that by the early twentieth century the Flexner model had helped to create the 20th-century academic health center, in which education, research, and practice were inseparable. While this had much improved medical practice by defining with increasing certainty the pathophysiological basis of disease, a single-minded focus on the pathophysiological had diverted much of mainstream American medicine from clinical conditions that were not well understood in mechanistic terms, and were not effectively treated by conventional therapies.[141]

By 2001 some form of CAM training was being offered by at least 75 out of 125 medical schools in the US.[142] Exceptionally, the School of Medicine of the University of Maryland, Baltimore includes a research institute for integrative medicine (a member entity of the Cochrane Collaboration).[90][143] Medical schools are responsible for conferring medical degrees, but a physician typically may not legally practice medicine until licensed by the local government authority. Licensed physicians in the US who have attended one of the established medical schools there have usually graduated Doctor of Medicine (MD).[144] All states require that applicants for MD licensure be graduates of an approved medical school and complete the United States Medical Licensing Exam (USMLE).[144]

There is a general scientific consensus that alternative therapies lack the requisite scientific validation, and their effectiveness is either unproved or disproved.[1][4][145][146] Many of the claims regarding the efficacy of alternative medicines are controversial, since research on them is frequently of low quality and methodologically flawed. Selective publication bias, marked differences in product quality and standardisation, and some companies making unsubstantiated claims call into question the claims of efficacy of isolated examples where there is evidence for alternative therapies.[148]

The Scientific Review of Alternative Medicine points to confusions in the general population a person may attribute symptomatic relief to an otherwise-ineffective therapy just because they are taking something (the placebo effect); the natural recovery from or the cyclical nature of an illness (the regression fallacy) gets misattributed to an alternative medicine being taken; a person not diagnosed with science-based medicine may never originally have had a true illness diagnosed as an alternative disease category.[149]

Edzard Ernst characterized the evidence for many alternative techniques as weak, nonexistent, or negative[150] and in 2011 published his estimate that about 7.4% were based on “sound evidence”, although he believes that may be an overestimate.[151] Ernst has concluded that 95% of the alternative treatments he and his team studied, including acupuncture, herbal medicine, homeopathy, and reflexology, are “statistically indistinguishable from placebo treatments”, but he also believes there is something that conventional doctors can usefully learn from the chiropractors and homeopath: this is the therapeutic value of the placebo effect, one of the strangest phenomena in medicine.[152][153]

In 2003, a project funded by the CDC identified 208 condition-treatment pairs, of which 58% had been studied by at least one randomized controlled trial (RCT), and 23% had been assessed with a meta-analysis.[154] According to a 2005 book by a US Institute of Medicine panel, the number of RCTs focused on CAM has risen dramatically.

As of 2005[update], the Cochrane Library had 145 CAM-related Cochrane systematic reviews and 340 non-Cochrane systematic reviews. An analysis of the conclusions of only the 145 Cochrane reviews was done by two readers. In 83% of the cases, the readers agreed. In the 17% in which they disagreed, a third reader agreed with one of the initial readers to set a rating. These studies found that, for CAM, 38.4% concluded positive effect or possibly positive (12.4%), 4.8% concluded no effect, 0.7% concluded harmful effect, and 56.6% concluded insufficient evidence. An assessment of conventional treatments found that 41.3% concluded positive or possibly positive effect, 20% concluded no effect, 8.1% concluded net harmful effects, and 21.3% concluded insufficient evidence. However, the CAM review used the more developed 2004 Cochrane database, while the conventional review used the initial 1998 Cochrane database.

In the same way as for conventional therapies, drugs, and interventions, it can be difficult to test the efficacy of alternative medicine in clinical trials. In instances where an established, effective, treatment for a condition is already available, the Helsinki Declaration states that withholding such treatment is unethical in most circumstances. Use of standard-of-care treatment in addition to an alternative technique being tested may produce confounded or difficult-to-interpret results.[156]

Cancer researcher Andrew J. Vickers has stated:

Contrary to much popular and scientific writing, many alternative cancer treatments have been investigated in good-quality clinical trials, and they have been shown to be ineffective. The label “unproven” is inappropriate for such therapies; it is time to assert that many alternative cancer therapies have been “disproven”.[157]

A research methods expert and author of Snake Oil Science, R. Barker Bausell, has stated that “it’s become politically correct to investigate nonsense.”[158] There are concerns that just having NIH support is being used to give unfounded “legitimacy to treatments that are not legitimate.”[159]

Use of placebos to achieve a placebo effect in integrative medicine has been criticized as, “…diverting research time, money, and other resources from more fruitful lines of investigation in order to pursue a theory that has no basis in biology.”[57][58]

Another critic has argued that academic proponents of integrative medicine sometimes recommend misleading patients by using known placebo treatments to achieve a placebo effect.[n 15] However, a 2010 survey of family physicians found that 56% of respondents said they had used a placebo in clinical practice as well. Eighty-five percent of respondents believed placebos can have both psychological and physical benefits.[161]

Integrative medicine has been criticized in that its practitioners, trained in science-based medicine, deliberately mislead patients by pretending placebos are not. “quackademic medicine” is a pejorative term used for integrative medicine, which medical professionals consider an infiltration of quackery into academic science-based medicine.[58]

An analysis of trends in the criticism of complementary and alternative medicine (CAM) in five prestigious American medical journals during the period of reorganization within medicine (19651999) was reported as showing that the medical profession had responded to the growth of CAM in three phases, and that in each phase, changes in the medical marketplace had influenced the type of response in the journals.[162] Changes included relaxed medical licensing, the development of managed care, rising consumerism, and the establishment of the USA Office of Alternative Medicine (later National Center for Complementary and Alternative Medicine, currently National Center for Complementary and Integrative Health).[n 16] In the “condemnation” phase, from the late 1960s to the early 1970s, authors had ridiculed, exaggerated the risks, and petitioned the state to contain CAM; in the “reassessment” phase (mid-1970s through early 1990s), when increased consumer utilization of CAM was prompting concern, authors had pondered whether patient dissatisfaction and shortcomings in conventional care contributed to the trend; in the “integration” phase of the 1990s physicians began learning to work around or administer CAM, and the subjugation of CAM to scientific scrutiny had become the primary means of control.[citation needed]

Practitioners of complementary medicine usually discuss and advise patients as to available alternative therapies. Patients often express interest in mind-body complementary therapies because they offer a non-drug approach to treating some health conditions.[164]

In addition to the social-cultural underpinnings of the popularity of alternative medicine, there are several psychological issues that are critical to its growth. One of the most critical is the placebo effect a well-established observation in medicine.[165] Related to it are similar psychological effects, such as the will to believe,[166] cognitive biases that help maintain self-esteem and promote harmonious social functioning,[166] and the post hoc, ergo propter hoc fallacy.[166]

The popularity of complementary & alternative medicine (CAM) may be related to other factors that Edzard Ernst mentioned in an interview in The Independent:

Why is it so popular, then? Ernst blames the providers, customers and the doctors whose neglect, he says, has created the opening into which alternative therapists have stepped. “People are told lies. There are 40 million websites and 39.9 million tell lies, sometimes outrageous lies. They mislead cancer patients, who are encouraged not only to pay their last penny but to be treated with something that shortens their lives. “At the same time, people are gullible. It needs gullibility for the industry to succeed. It doesn’t make me popular with the public, but it’s the truth.[167]

Paul Offit proposed that “alternative medicine becomes quackery” in four ways: by recommending against conventional therapies that are helpful, promoting potentially harmful therapies without adequate warning, draining patients’ bank accounts, or by promoting “magical thinking.”[45]

Authors have speculated on the socio-cultural and psychological reasons for the appeal of alternative medicines among the minority using them in lieu of conventional medicine. There are several socio-cultural reasons for the interest in these treatments centered on the low level of scientific literacy among the public at large and a concomitant increase in antiscientific attitudes and new age mysticism.[166] Related to this are vigorous marketing[168] of extravagant claims by the alternative medical community combined with inadequate media scrutiny and attacks on critics.[166][169]

There is also an increase in conspiracy theories toward conventional medicine and pharmaceutical companies, mistrust of traditional authority figures, such as the physician, and a dislike of the current delivery methods of scientific biomedicine, all of which have led patients to seek out alternative medicine to treat a variety of ailments.[169] Many patients lack access to contemporary medicine, due to a lack of private or public health insurance, which leads them to seek out lower-cost alternative medicine.[170] Medical doctors are also aggressively marketing alternative medicine to profit from this market.[168]

Patients can be averse to the painful, unpleasant, and sometimes-dangerous side effects of biomedical treatments. Treatments for severe diseases such as cancer and HIV infection have well-known, significant side-effects. Even low-risk medications such as antibiotics can have potential to cause life-threatening anaphylactic reactions in a very few individuals. Many medications may cause minor but bothersome symptoms such as cough or upset stomach. In all of these cases, patients may be seeking out alternative treatments to avoid the adverse effects of conventional treatments.[166][169]

Complementary and alternative medicine (CAM) has been described as a broad domain of healing resources that encompasses all health systems, modalities, and practices and their accompanying theories and beliefs, other than those intrinsic to the politically dominant health system of a particular society or culture in a given historical period. CAM includes all such practices and ideas self-defined by their users as preventing or treating illness or promoting health and well-being. Boundaries within CAM and between the CAM domain and that of the dominant system are not always sharp or fixed.[72][dubious discuss]

According to recent research, the increasing popularity of the CAM needs to be explained by moral convictions or lifestyle choices rather than by economic reasoning.[171]

In developing nations, access to essential medicines is severely restricted by lack of resources and poverty. Traditional remedies, often closely resembling or forming the basis for alternative remedies, may comprise primary healthcare or be integrated into the healthcare system. In Africa, traditional medicine is used for 80% of primary healthcare, and in developing nations as a whole over one-third of the population lack access to essential medicines.[172]

Some have proposed adopting a prize system to reward medical research.[173] However, public funding for research exists. Increasing the funding for research on alternative medicine techniques is the purpose of the US National Center for Complementary and Alternative Medicine. NCCIH and its predecessor, the Office of Alternative Medicine, have spent more than US$2.5 billion on such research since 1992; this research has largely not demonstrated the efficacy of alternative treatments.[158][174][175][176]

That alternative medicine has been on the rise “in countries where Western science and scientific method generally are accepted as the major foundations for healthcare, and ‘evidence-based’ practice is the dominant paradigm” was described as an “enigma” in the Medical Journal of Australia.[177]

In the United States, the 1974 Child Abuse Prevention and Treatment Act (CAPTA) required that for states to receive federal money, they had to grant religious exemptions to child neglect and abuse laws regarding religion-based healing practices.[178] Thirty-one states have child-abuse religious exemptions.[179]

The use of alternative medicine in the US has increased,[1][180] with a 50 percent increase in expenditures and a 25 percent increase in the use of alternative therapies between 1990 and 1997 in America.[180] Americans spend many billions on the therapies annually.[180] Most Americans used CAM to treat and/or prevent musculoskeletal conditions or other conditions associated with chronic or recurring pain.[170] In America, women were more likely than men to use CAM, with the biggest difference in use of mind-body therapies including prayer specifically for health reasons”.[170] In 2008, more than 37% of American hospitals offered alternative therapies, up from 27 percent in 2005, and 25% in 2004.[181][182] More than 70% of the hospitals offering CAM were in urban areas.[182]

A survey of Americans found that 88 percent thought that “there are some good ways of treating sickness that medical science does not recognize”.[1] Use of magnets was the most common tool in energy medicine in America, and among users of it, 58 percent described it as at least “sort of scientific”, when it is not at all scientific.[1] In 2002, at least 60 percent of US medical schools have at least some class time spent teaching alternative therapies.[1] “Therapeutic touch”, was taught at more than 100 colleges and universities in 75 countries before the practice was debunked by a nine-year-old child for a school science project.[1][118]

The most common CAM therapies used in the US in 2002 were prayer (45%), herbalism (19%), breathing meditation (12%), meditation (8%), chiropractic medicine (8%), yoga (56%), body work (5%), diet-based therapy (4%), progressive relaxation (3%), mega-vitamin therapy (3%) and Visualization (2%)[170][183]

In Britain, the most often used alternative therapies were Alexander technique, Aromatherapy, Bach and other flower remedies, Body work therapies including massage, Counseling stress therapies, hypnotherapy, Meditation, Reflexology, Shiatsu, Ayurvedic medicine, Nutritional medicine, and Yoga.[184] Ayurvedic medicine remedies are mainly plant based with some use of animal materials. Safety concerns include the use of herbs containing toxic compounds and the lack of quality control in Ayurvedic facilities.[112][114]

According to the National Health Service (England), the most commonly used complementary and alternative medicines (CAM) supported by the NHS in the UK are: acupuncture, aromatherapy, chiropractic, homeopathy, massage, osteopathy and clinical hypnotherapy.[186]

Complementary therapies are often used in palliative care or by practitioners attempting to manage chronic pain in patients. Integrative medicine is considered more acceptable in the interdisciplinary approach used in palliative care than in other areas of medicine. “From its early experiences of care for the dying, palliative care took for granted the necessity of placing patient values and lifestyle habits at the core of any design and delivery of quality care at the end of life. If the patient desired complementary therapies, and as long as such treatments provided additional support and did not endanger the patient, they were considered acceptable.”[187] The non-pharmacologic interventions of complementary medicine can employ mind-body interventions designed to “reduce pain and concomitant mood disturbance and increase quality of life.”[188]

In Austria and Germany complementary and alternative medicine is mainly in the hands of doctors with MDs,[30] and half or more of the American alternative practitioners are licensed MDs.[189] In Germany herbs are tightly regulated: half are prescribed by doctors and covered by health insurance.[190]

Some professions of complementary/traditional/alternative medicine, such as chiropractic, have achieved full regulation in North America and other parts of the world and are regulated in a manner similar to that governing science-based medicine. In contrast, other approaches may be partially recognized and others have no regulation at all. Regulation and licensing of alternative medicine ranges widely from country to country, and state to state.

Government bodies in the US and elsewhere have published information or guidance about alternative medicine. The U.S. Food and Drug Administration (FDA), has issued online warnings for consumers about medication health fraud.[192] This includes a section on Alternative Medicine Fraud,[193] such as a warning that Ayurvedic products generally have not been approved by the FDA before marketing.[194]

Many of the claims regarding the safety and efficacy of alternative medicine are controversial. Some alternative treatments have been associated with unexpected side effects, which can be fatal.[195]

A commonly voiced concerns about complementary alternative medicine (CAM) is the way it’s regulated. There have been significant developments in how CAMs should be assessed prior to re-sale in the United Kingdom and the European Union (EU) in the last 2 years. Despite this, it has been suggested that current regulatory bodies have been ineffective in preventing deception of patients as many companies have re-labelled their drugs to avoid the new laws.[196] There is no general consensus about how to balance consumer protection (from false claims, toxicity, and advertising) with freedom to choose remedies.

Advocates of CAM suggest that regulation of the industry will adversely affect patients looking for alternative ways to manage their symptoms, even if many of the benefits may represent the placebo affect.[197] Some contend that alternative medicines should not require any more regulation than over-the-counter medicines that can also be toxic in overdose (such as paracetamol).[198]

Forms of alternative medicine that are biologically active can be dangerous even when used in conjunction with conventional medicine. Examples include immuno-augmentation therapy, shark cartilage, bioresonance therapy, oxygen and ozone therapies, and insulin potentiation therapy. Some herbal remedies can cause dangerous interactions with chemotherapy drugs, radiation therapy, or anesthetics during surgery, among other problems.[31] An anecdotal example of these dangers was reported by Associate Professor Alastair MacLennan of Adelaide University, Australia regarding a patient who almost bled to death on the operating table after neglecting to mention that she had been taking “natural” potions to “build up her strength” before the operation, including a powerful anticoagulant that nearly caused her death.[199]

To ABC Online, MacLennan also gives another possible mechanism:

And lastly [sic] there’s the cynicism and disappointment and depression that some patients get from going on from one alternative medicine to the next, and they find after three months the placebo effect wears off, and they’re disappointed and they move on to the next one, and they’re disappointed and disillusioned, and that can create depression and make the eventual treatment of the patient with anything effective difficult, because you may not get compliance, because they’ve seen the failure so often in the past.[200]

Conventional treatments are subjected to testing for undesired side-effects, whereas alternative treatments, in general, are not subjected to such testing at all. Any treatment whether conventional or alternative that has a biological or psychological effect on a patient may also have potential to possess dangerous biological or psychological side-effects. Attempts to refute this fact with regard to alternative treatments sometimes use the appeal to nature fallacy, i.e., “That which is natural cannot be harmful.” Specific groups of patients such as patients with impaired hepatic or renal function are more susceptible to side effects of alternative remedies.[201][202]

An exception to the normal thinking regarding side-effects is Homeopathy. Since 1938, the U.S. Food and Drug Administration (FDA) has regulated homeopathic products in “several significantly different ways from other drugs.”[203] Homeopathic preparations, termed “remedies”, are extremely dilute, often far beyond the point where a single molecule of the original active (and possibly toxic) ingredient is likely to remain. They are, thus, considered safe on that count, but “their products are exempt from good manufacturing practice requirements related to expiration dating and from finished product testing for identity and strength”, and their alcohol concentration may be much higher than allowed in conventional drugs.[203]

Those having experienced or perceived success with one alternative therapy for a minor ailment may be convinced of its efficacy and persuaded to extrapolate that success to some other alternative therapy for a more serious, possibly life-threatening illness.[204] For this reason, critics argue that therapies that rely on the placebo effect to define success are very dangerous. According to mental health journalist Scott Lilienfeld in 2002, “unvalidated or scientifically unsupported mental health practices can lead individuals to forgo effective treatments” and refers to this as “opportunity cost”. Individuals who spend large amounts of time and money on ineffective treatments may be left with precious little of either, and may forfeit the opportunity to obtain treatments that could be more helpful. In short, even innocuous treatments can indirectly produce negative outcomes.[205] Between 2001 and 2003, four children died in Australia because their parents chose ineffective naturopathic, homeopathic, or other alternative medicines and diets rather than conventional therapies.[206]

There have always been “many therapies offered outside of conventional cancer treatment centers and based on theories not found in biomedicine. These alternative cancer cures have often been described as ‘unproven,’ suggesting that appropriate clinical trials have not been conducted and that the therapeutic value of the treatment is unknown.” However, “many alternative cancer treatments have been investigated in good-quality clinical trials, and they have been shown to be ineffective….The label ‘unproven’ is inappropriate for such therapies; it is time to assert that many alternative cancer therapies have been ‘disproven’.”[157]

Edzard Ernst has stated:

…any alternative cancer cure is bogus by definition. There will never be an alternative cancer cure. Why? Because if something looked halfway promising, then mainstream oncology would scrutinize it, and if there is anything to it, it would become mainstream almost automatically and very quickly. All curative “alternative cancer cures” are based on false claims, are bogus, and, I would say, even criminal.[207]

“CAM”, meaning “complementary and alternative medicine”, is not as well researched as conventional medicine, which undergoes intense research before release to the public.[208] Funding for research is also sparse making it difficult to do further research for effectiveness of CAM.[209] Most funding for CAM is funded by government agencies.[208] Proposed research for CAM are rejected by most private funding agencies because the results of research are not reliable.[208] The research for CAM has to meet certain standards from research ethics committees, which most CAM researchers find almost impossible to meet.[208] Even with the little research done on it, CAM has not been proven to be effective.[210]

Steven Novella, a neurologist at Yale School of Medicine, wrote that government funded studies of integrating alternative medicine techniques into the mainstream are “used to lend an appearance of legitimacy to treatments that are not legitimate.”[159] Marcia Angell considered that critics felt that healthcare practices should be classified based solely on scientific evidence, and if a treatment had been rigorously tested and found safe and effective, science-based medicine will adopt it regardless of whether it was considered “alternative” to begin with.[3] It is possible for a method to change categories (proven vs. unproven), based on increased knowledge of its effectiveness or lack thereof. A prominent supporter of this position is George D. Lundberg, former editor of the Journal of the American Medical Association (JAMA).[47]

Writing in 1999 in CA: A Cancer Journal for Clinicians Barrie R. Cassileth mentioned a 1997 letter to the US Senate Subcommittee on Public Health and Safety, which had deplored the lack of critical thinking and scientific rigor in OAM-supported research, had been signed by four Nobel Laureates and other prominent scientists. (This was supported by the National Institutes of Health (NIH).)[211]

In March 2009 a staff writer for the Washington Post reported that the impending national discussion about broadening access to health care, improving medical practice and saving money was giving a group of scientists an opening to propose shutting down the National Center for Complementary and Alternative Medicine. They quoted one of these scientists, Steven Salzberg, a genome researcher and computational biologist at the University of Maryland, as saying “One of our concerns is that NIH is funding pseudoscience.” They noted that the vast majority of studies were based on fundamental misunderstandings of physiology and disease, and had shown little or no effect.[159]

Writers such as Carl Sagan, a noted astrophysicist, advocate of scientific skepticism and the author of The Demon-Haunted World: Science as a Candle in the Dark (1996), have lambasted the lack of empirical evidence to support the existence of the putative energy fields on which these therapies are predicated.

Sampson has also pointed out that CAM tolerated contradiction without thorough reason and experiment.[212] Barrett has pointed out that there is a policy at the NIH of never saying something doesn’t work only that a different version or dose might give different results.[158] Barrett also expressed concern that, just because some “alternatives” have merit, there is the impression that the rest deserve equal consideration and respect even though most are worthless, since they are all classified under the one heading of alternative medicine.[213]

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Alternative Medicine | Fox News

82-year-old polio survivor Mona Randolph uses one of only three “iron lungs” known to still be in use in the U.S. The iron lung, which was invented in 1920s, was often used on polio patients who were unable to breathe after the virus paralyzed muscle groups in the chest. Six nights a week, Randolph sleeps up to her neck in a noisy, airtight, 75-year-old iron tube.

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Category:Alternative medicine – Wikipedia

Alternative medicine encompasses methods used in both complementary medicine and alternative medicine, known collectively as complementary and alternative medicine (CAM). These methods are used in place of (“alternative to”), or in addition to (“complementary to”), conventional medical treatments. The terms are primarily used in the western world, and include several traditional medicine techniques practiced throughout the world.

If you add something to this category it should also be added to list of forms of alternative medicine.

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Category:Alternative medicine – Wikipedia

Stem-cell therapy – Wikipedia

This article is about the medical therapy. For the cell type, see Stem cell.

Stem-cell therapy is the use of stem cells to treat or prevent a disease or condition.[1]

Bone marrow transplant is the most widely used stem-cell therapy, but some therapies derived from umbilical cord blood are also in use. Research is underway to develop various sources for stem cells, as well as to apply stem-cell treatments for neurodegenerative diseases and conditions such as diabetes and heart disease, among others.

Stem-cell therapy has become controversial following developments such as the ability of scientists to isolate and culture embryonic stem cells, to create stem cells using somatic cell nuclear transfer and their use of techniques to create induced pluripotent stem cells. This controversy is often related to abortion politics and to human cloning. Additionally, efforts to market treatments based on transplant of stored umbilical cord blood have been controversial.

For over 30 years, bone marrow has been used to treat cancer patients with conditions such as leukaemia and lymphoma; this is the only form of stem-cell therapy that is widely practiced.[2][3][4] During chemotherapy, most growing cells are killed by the cytotoxic agents. These agents, however, cannot discriminate between the leukaemia or neoplastic cells, and the hematopoietic stem cells within the bone marrow. It is this side effect of conventional chemotherapy strategies that the stem-cell transplant attempts to reverse; a donor’s healthy bone marrow reintroduces functional stem cells to replace the cells lost in the host’s body during treatment. The transplanted cells also generate an immune response that helps to kill off the cancer cells; this process can go too far, however, leading to graft vs host disease, the most serious side effect of this treatment.[5]

Another stem-cell therapy called Prochymal, was conditionally approved in Canada in 2012 for the management of acute graft-vs-host disease in children who are unresponsive to steroids.[6] It is an allogenic stem therapy based on mesenchymal stem cells (MSCs) derived from the bone marrow of adult donors. MSCs are purified from the marrow, cultured and packaged, with up to 10,000 doses derived from a single donor. The doses are stored frozen until needed.[7]

The FDA has approved five hematopoietic stem-cell products derived from umbilical cord blood, for the treatment of blood and immunological diseases.[8]

In 2014, the European Medicines Agency recommended approval of limbal stem cells for people with severe limbal stem cell deficiency due to burns in the eye.[9]

Stem cells are being studied for a number of reasons. The molecules and exosomes released from stem cells are also being studied in an effort to make medications.[10] The paracrine soluble factors produced by stem cells, known as the stem cell secretome, has been found to be the predominant mechanism by which stem cell-based therapies mediate their effects in degenerative, auto-immune and inflammatory diseases.[11]

Research has been conducted on the effects of stem cells on animal models of brain degeneration, such as in Parkinson’s, Amyotrophic lateral sclerosis, and Alzheimer’s disease.[12][13][14] There have been preliminary studies related to multiple sclerosis.[15][16]

Healthy adult brains contain neural stem cells which divide to maintain general stem-cell numbers, or become progenitor cells. In healthy adult laboratory animals, progenitor cells migrate within the brain and function primarily to maintain neuron populations for olfaction (the sense of smell). Pharmacological activation of endogenous neural stem cells has been reported to induce neuroprotection and behavioral recovery in adult rat models of neurological disorder.[17][18][19]

Stroke and traumatic brain injury lead to cell death, characterized by a loss of neurons and oligodendrocytes within the brain. Clinical and animal studies have been conducted into the use of stem cells in cases of spinal cord injury.[20][21][22]

Stems cells are studied in people with severe heart disease.[23] The work by Bodo-Eckehard Strauer[24] was discredited by identifying hundreds of factual contradictions.[25] Among several clinical trials reporting that adult stem cell therapy is safe and effective, actual evidence of benefit has been reported from only a few studies.[26] Some preliminary clinical trials achieved only modest improvements in heart function following use of bone marrow stem cell therapy.[27][28]

Stem-cell therapy for treatment of myocardial infarction usually makes use of autologous bone marrow stem cells, but other types of adult stem cells may be used, such as adipose-derived stem cells.[29]

Possible mechanisms of recovery include:[12]

In 2013, studies of autologous bone marrow stem cells on ventricular function were found to contain “hundreds” of discrepancies.[30] Critics report that of 48 reports there seemed to be just five underlying trials, and that in many cases whether they were randomized or merely observational accepter-versus-rejecter, was contradictory between reports of the same trial. One pair of reports of identical baseline characteristics and final results, was presented in two publications as, respectively, a 578 patient randomized trial and as a 391 patient observational study. Other reports required (impossible) negative standard deviations in subsets of patients, or contained fractional patients, negative NYHA classes. Overall there were many more patients published as having receiving stem cells in trials, than the number of stem cells processed in the hospital’s laboratory during that time. A university investigation, closed in 2012 without reporting, was reopened in July 2013.[31]

In 2014, a meta-analysis on stem cell therapy using bone marrow stem cells for heart disease revealed discrepancies in published clinical trial reports, whereby studies with a higher number of discrepancies showed an increase in effect sizes.[32] Another meta-analysis based on the intra-subject data of 12 randomised trials was unable to find any significant benefits of stem cell therapy on primary endpoints, such as major adverse events or increase in heart function measures, concluding there was no benefit.[33]

The TIME trial, which used a randomised, double blind, placebo-controlled trial design, concluded that “bone marrow mononuclear cells administration did not improve recovery of LV function over 2 years” in people who had a myocardial infarction.[34] Accordingly, the BOOST-2 trial conducted in 10 medical centres in Germany and Norway reported that the trial result “does not support the use of nucleated BMCs in patients with STEMI and moderately reduced LVEF”.[35] Furthermore, the trial also did not meet any other secondary MRI endpoints,[36] leading to a conclusion that intracoronary bone marrow stem cell therapy does not offer a functional or clinical benefit.[37]

The specificity of the human immune-cell repertoire is what allows the human body to defend itself from rapidly adapting antigens. However, the immune system is vulnerable to degradation upon the pathogenesis of disease, and because of the critical role that it plays in overall defense, its degradation is often fatal to the organism as a whole. Diseases of hematopoietic cells are diagnosed and classified via a subspecialty of pathology known as hematopathology. The specificity of the immune cells is what allows recognition of foreign antigens, causing further challenges in the treatment of immune disease. Identical matches between donor and recipient must be made for successful transplantation treatments, but matches are uncommon, even between first-degree relatives. Research using both hematopoietic adult stem cells and embryonic stem cells has provided insight into the possible mechanisms and methods of treatment for many of these ailments.[citation needed]

Fully mature human red blood cells may be generated ex vivo by hematopoietic stem cells (HSCs), which are precursors of red blood cells. In this process, HSCs are grown together with stromal cells, creating an environment that mimics the conditions of bone marrow, the natural site of red-blood-cell growth. Erythropoietin, a growth factor, is added, coaxing the stem cells to complete terminal differentiation into red blood cells.[38] Further research into this technique should have potential benefits to gene therapy, blood transfusion, and topical medicine.

In 2004, scientists at King’s College London discovered a way to cultivate a complete tooth in mice[39] and were able to grow bioengineered teeth stand-alone in the laboratory. Researchers are confident that the tooth regeneration technology can be used to grow live teeth in human patients.

In theory, stem cells taken from the patient could be coaxed in the lab turning into a tooth bud which, when implanted in the gums, will give rise to a new tooth, and would be expected to be grown in a time over three weeks.[40] It will fuse with the jawbone and release chemicals that encourage nerves and blood vessels to connect with it. The process is similar to what happens when humans grow their original adult teeth. Many challenges remain, however, before stem cells could be a choice for the replacement of missing teeth in the future.[41][42]

Heller has reported success in re-growing cochlea hair cells with the use of embryonic stem cells.[43]

Since 2003, researchers have successfully transplanted corneal stem cells into damaged eyes to restore vision. “Sheets of retinal cells used by the team are harvested from aborted fetuses, which some people find objectionable.” When these sheets are transplanted over the damaged cornea, the stem cells stimulate renewed repair, eventually restore vision.[44] The latest such development was in June 2005, when researchers at the Queen Victoria Hospital of Sussex, England were able to restore the sight of forty patients using the same technique. The group, led by Sheraz Daya, was able to successfully use adult stem cells obtained from the patient, a relative, or even a cadaver. Further rounds of trials are ongoing.[45]

Diabetes patients lose the function of insulin-producing beta cells within the pancreas.[46] In recent experiments, scientists have been able to coax embryonic stem cell to turn into beta cells in the lab. In theory if the beta cell is transplanted successfully, they will be able to replace malfunctioning ones in a diabetic patient.[47]

Clinical case reports in the treatment orthopaedic conditions have been reported. To date, the focus in the literature for musculoskeletal care appears to be on mesenchymal stem cells. Centeno et al. have published MRI evidence of increased cartilage and meniscus volume in individual human subjects.[48][unreliable medical source?][49] The results of trials that include a large number of subjects, are yet to be published. However, a published safety study conducted in a group of 227 patients over a 3-4-year period shows adequate safety and minimal complications associated with mesenchymal cell transplantation.[50]

Wakitani has also published a small case series of nine defects in five knees involving surgical transplantation of mesenchymal stem cells with coverage of the treated chondral defects.[51]

Stem cells can also be used to stimulate the growth of human tissues. In an adult, wounded tissue is most often replaced by scar tissue, which is characterized in the skin by disorganized collagen structure, loss of hair follicles and irregular vascular structure. In the case of wounded fetal tissue, however, wounded tissue is replaced with normal tissue through the activity of stem cells.[52] A possible method for tissue regeneration in adults is to place adult stem cell “seeds” inside a tissue bed “soil” in a wound bed and allow the stem cells to stimulate differentiation in the tissue bed cells. This method elicits a regenerative response more similar to fetal wound-healing than adult scar tissue formation.[52] Researchers are still investigating different aspects of the “soil” tissue that are conducive to regeneration.[52]

Culture of human embryonic stem cells in mitotically inactivated porcine ovarian fibroblasts (POF) causes differentiation into germ cells (precursor cells of oocytes and spermatozoa), as evidenced by gene expression analysis.[53]

Human embryonic stem cells have been stimulated to form Spermatozoon-like cells, yet still slightly damaged or malformed.[54] It could potentially treat azoospermia.

In 2012, oogonial stem cells were isolated from adult mouse and human ovaries and demonstrated to be capable of forming mature oocytes.[55] These cells have the potential to treat infertility.

Destruction of the immune system by the HIV is driven by the loss of CD4+ T cells in the peripheral blood and lymphoid tissues. Viral entry into CD4+ cells is mediated by the interaction with a cellular chemokine receptor, the most common of which are CCR5 and CXCR4. Because subsequent viral replication requires cellular gene expression processes, activated CD4+ cells are the primary targets of productive HIV infection.[56] Recently scientists have been investigating an alternative approach to treating HIV-1/AIDS, based on the creation of a disease-resistant immune system through transplantation of autologous, gene-modified (HIV-1-resistant) hematopoietic stem and progenitor cells (GM-HSPC).[57]

Stem cells are thought to mediate repair via five primary mechanisms: 1) providing an anti-inflammatory effect, 2) homing to damaged tissues and recruiting other cells, such as endothelial progenitor cells, that are necessary for tissue growth, 3) supporting tissue remodeling over scar formation, 4) inhibiting apoptosis, and 5) differentiating into bone, cartilage, tendon, and ligament tissue.[58][59]

To further enrich blood supply to the damaged areas, and consequently promote tissue regeneration, platelet-rich plasma could be used in conjunction with stem cell transplantation.[60][61] The efficacy of some stem cell populations may also be affected by the method of delivery; for instance, to regenerate bone, stem cells are often introduced in a scaffold where they produce the minerals necessary for generation of functional bone.[60][61][62][63]

Stem cells have also been shown to have a low immunogenicity due to the relatively low number of MHC molecules found on their surface. In addition, they have been found to secrete chemokines that alter the immune response and promote tolerance of the new tissue. This allows for allogeneic treatments to be performed without a high rejection risk.[64]

The ability to grow up functional adult tissues indefinitely in culture through Directed differentiation creates new opportunities for drug research. Researchers are able to grow up differentiated cell lines and then test new drugs on each cell type to examine possible interactions in vitro before performing in vivo studies. This is critical in the development of drugs for use in veterinary research because of the possibilities of species specific interactions. The hope is that having these cell lines available for research use will reduce the need for research animals used because effects on human tissue in vitro will provide insight not normally known before the animal testing phase.[65]

Stem cells are being explored for use in conservation efforts. Spermatogonial stem cells have been harvested from a rat and placed into a mouse host and fully mature sperm were produced with the ability to produce viable offspring. Currently research is underway to find suitable hosts for the introduction of donor spermatogonial stem cells. If this becomes a viable option for conservationists, sperm can be produced from high genetic quality individuals who die before reaching sexual maturity, preserving a line that would otherwise be lost.[66]

Most stem cells intended for regenerative therapy are generally isolated either from the patient’s bone marrow or from adipose tissue.[61][63] Mesenchymal stem cells can differentiate into the cells that make up bone, cartilage, tendons, and ligaments, as well as muscle, neural and other progenitor tissues, they have been the main type of stem cells studied in the treatment of diseases affecting these tissues.[67][68] The number of stem cells transplanted into damaged tissue may alter efficacy of treatment. Accordingly, stem cells derived from bone marrow aspirates, for instance, are cultured in specialized laboratories for expansion to millions of cells.[61][63] Although adipose-derived tissue also requires processing prior to use, the culturing methodology for adipose-derived stem cells is not as extensive as that for bone marrow-derived cells.[69][70] While it is thought that bone-marrow derived stem cells are preferred for bone, cartilage, ligament, and tendon repair, others believe that the less challenging collection techniques and the multi-cellular microenvironment already present in adipose-derived stem cell fractions make the latter the preferred source for autologous transplantation.[60]

New sources of mesenchymal stem cells are being researched, including stem cells present in the skin and dermis which are of interest because of the ease at which they can be harvested with minimal risk to the animal.[71] Hematopoetic stem cells have also been discovered to be travelling in the blood stream and possess equal differentiating ability as other mesenchymal stem cells, again with a very non-invasive harvesting technique.[72]

There is widespread controversy over the use of human embryonic stem cells. This controversy primarily targets the techniques used to derive new embryonic stem cell lines, which often requires the destruction of the blastocyst. Opposition to the use of human embryonic stem cells in research is often based on philosophical, moral, or religious objections.[73] There is other stem cell research that does not involve the destruction of a human embryo, and such research involves adult stem cells, amniotic stem cells, and induced pluripotent stem cells.

On 23 January 2009, the US Food and Drug Administration gave clearance to Geron Corporation for the initiation of the first clinical trial of an embryonic stem-cell-based therapy on humans. The trial aimed evaluate the drug GRNOPC1, embryonic stem cell-derived oligodendrocyte progenitor cells, on patients with acute spinal cord injury. The trial was discontinued in November 2011 so that the company could focus on therapies in the “current environment of capital scarcity and uncertain economic conditions”.[74] In 2013 biotechnology and regenerative medicine company BioTime (AMEX:BTX) acquired Geron’s stem cell assets in a stock transaction, with the aim of restarting the clinical trial.[75]

Scientists have reported that MSCs when transfused immediately within few hours post thawing may show reduced function or show decreased efficacy in treating diseases as compared to those MSCs which are in log phase of cell growth(fresh), so cryopreserved MSCs should be brought back into log phase of cell growth in invitro culture before these are administered for clinical trials or experimental therapies, re-culturing of MSCs will help in recovering from the shock the cells get during freezing and thawing. Various clinical trials on MSCs have failed which used cryopreserved product immediately post thaw as compared to those clinical trials which used fresh MSCs.[76]

Research has been conducted on horses, dogs, and cats can benefit the development of stem cell treatments in veterinary medicine and can target a wide range of injuries and diseases such as myocardial infarction, stroke, tendon and ligament damage, osteoarthritis, osteochondrosis and muscular dystrophy both in large animals, as well as humans.[77][78][79][80] While investigation of cell-based therapeutics generally reflects human medical needs, the high degree of frequency and severity of certain injuries in racehorses has put veterinary medicine at the forefront of this novel regenerative approach.[81] Companion animals can serve as clinically relevant models that closely mimic human disease.[82][83]

Veterinary applications of stem cell therapy as a means of tissue regeneration have been largely shaped by research that began with the use of adult-derived mesenchymal stem cells to treat animals with injuries or defects affecting bone, cartilage, ligaments and/or tendons.[84][67][85] There are two main categories of stem cells used for treatments: allogeneic stem cells derived from a genetically different donor within the same species[63][86] and autologous mesenchymal stem cells, derived from the patient prior to use in various treatments.[60] A third category, xenogenic stem cells, or stem cells derived from different species, are used primarily for research purposes, especially for human treatments.[65]

Bone has a unique and well documented natural healing process that normally is sufficient to repair fractures and other common injuries. Misaligned breaks due to severe trauma, as well as treatments like tumor resections of bone cancer, are prone to improper healing if left to the natural process alone. Scaffolds composed of natural and artificial components are seeded with mesenchymal stem cells and placed in the defect. Within four weeks of placing the scaffold, newly formed bone begins to integrate with the old bone and within 32 weeks, full union is achieved.[87] Further studies are necessary to fully characterize the use of cell-based therapeutics for treatment of bone fractures.

Stem cells have been used to treat degenerative bone diseases. The normally recommended treatment for dogs that have LeggCalvePerthes disease is to remove the head of the femur after the degeneration has progressed. Recently, mesenchymal stem cells have been injected directly in to the head of the femur, with success not only in bone regeneration, but also in pain reduction.[87]

Because of the general positive healing capabilities of stem cells, they have gained interest for the treatment of cutaneous wounds. This is important interest for those with reduced healing capabilities, like diabetics and those undergoing chemotherapy. In one trial, stem cells were isolated from the Wharton’s jelly of the umbilical cord. These cells were injected directly into the wounds. Within a week, full re-epithelialization of the wounds had occurred, compared to minor re-epithelialization in the control wounds. This showed the capabilities of mesenchymal stem cells in the repair of epidermal tissues.[88]

Soft-palate defects in horses are caused by a failure of the embryo to fully close at the midline during embryogenesis. These are often not found until after they have become worse because of the difficulty in visualizing the entire soft palate. This lack of visualization is thought to also contribute to the low success rate in surgical intervention to repair the defect. As a result, the horse often has to be euthanized. Recently, the use of mesenchymal stem cells has been added to the conventional treatments. After the surgeon has sutured the palate closed, autologous mesenchymal cells are injected into the soft palate. The stem cells were found to be integrated into the healing tissue especially along the border with the old tissue. There was also a large reduction in the number of inflammatory cells present, which is thought to aid in the healing process.[89]

Autologous stem cell-based treatments for ligament injury, tendon injury, osteoarthritis, osteochondrosis, and sub-chondral bone cysts have been commercially available to practicing veterinarians to treat horses since 2003 in the United States and since 2006 in the United Kingdom. Autologous stem cell based treatments for tendon injury, ligament injury, and osteoarthritis in dogs have been available to veterinarians in the United States since 2005. Over 3000 privately owned horses and dogs have been treated with autologous adipose-derived stem cells. The efficacy of these treatments has been shown in double-blind clinical trials for dogs with osteoarthritis of the hip and elbow and horses with tendon damage.[90][91]

Race horses are especially prone to injuries of the tendon and ligaments. Conventional therapies are very unsuccessful in returning the horse to full functioning potential. Natural healing, guided by the conventional treatments, leads to the formation of fibrous scar tissue that reduces flexibility and full joint movement. Traditional treatments prevented a large number of horses from returning to full activity and also have a high incidence of re-injury due to the stiff nature of the scarred tendon. Introduction of both bone marrow and adipose derived stem cells, along with natural mechanical stimulus promoted the regeneration of tendon tissue. The natural movement promoted the alignment of the new fibers and tendocytes with the natural alignment found in uninjured tendons. Stem cell treatment not only allowed more horses to return to full duty and also greatly reduced the re-injury rate over a three-year period.[64]

The use of embryonic stem cells has also been applied to tendon repair. The embryonic stem cells were shown to have a better survival rate in the tendon as well as better migrating capabilities to reach all areas of damaged tendon. The overall repair quality was also higher, with better tendon architecture and collagen formed. There was also no tumor formation seen during the three-month experimental period. Long-term studies need to be carried out to examine the long-term efficacy and risks associated with the use of embryonic stem cells.[64] Similar results have been found in small animals.[64]

Osteoarthritis is the main cause of joint pain both in animals and humans. Horses and dogs are most frequently affected by arthritis. Natural cartilage regeneration is very limited and no current drug therapies are curative, but rather look to reduce the symptoms associated with the degeneration. Different types of mesenchymal stem cells and other additives are still being researched to find the best type of cell and method for long-term treatment.[64]

Adipose-derived mesenchymal cells are currently the most often used because of the non-invasive harvesting. There has been a lot of success recently injecting mesenchymal stem cells directly into the joint. This is a recently developed, non-invasive technique developed for easier clinical use. Dogs receiving this treatment showed greater flexibility in their joints and less pain.[92]

Stem cells have successfully been used to ameliorate healing in the heart after myocardial infarction in dogs. Adipose and bone marrow derived stem cells were removed and induced to a cardiac cell fate before being injected into the heart. The heart was found to have improved contractility and a reduction in the damaged area four weeks after the stem cells were applied.[93]

A different trial is underway for a patch made of a porous substance onto which the stem cells are “seeded” in order to induce tissue regeneration in heart defects. Tissue was regenerated and the patch was well incorporated into the heart tissue. This is thought to be due, in part, to improved angiogenesis and reduction of inflammation. Although cardiomyocytes were produced from the mesenchymal stem cells, they did not appear to be contractile. Other treatments that induced a cardiac fate in the cells before transplanting had greater success at creating contractile heart tissue.[94]

Spinal cord injuries are one of the most common traumas brought into veterinary hospitals.[87] Spinal injuries occur in two ways after the trauma: the primary mechanical damage, and in secondary processes, like inflammation and scar formation, in the days following the trauma. These cells involved in the secondary damage response secrete factors that promote scar formation and inhibit cellular regeneration. Mesenchymal stem cells that are induced to a neural cell fate are loaded onto a porous scaffold and are then implanted at the site of injury. The cells and scaffold secrete factors that counteract those secreted by scar forming cells and promote neural regeneration. Eight weeks later, dogs treated with stem cells showed immense improvement over those treated with conventional therapies. Dogs treated with stem cells were able to occasionally support their own weight, which has not been seen in dogs undergoing conventional therapies.[95][96][97]

Treatments are also in clinical trials to repair and regenerate peripheral nerves. Peripheral nerves are more likely to be damaged, but the effects of the damage are not as widespread as seen in injuries to the spinal cord. Treatments are currently in clinical trials to repair severed nerves, with early success. Stem cells induced to a neural fate injected in to a severed nerve. Within four weeks, regeneration of previously damaged stem cells and completely formed nerve bundles were observed.[71]

Stem cells are also in clinical phases for treatment in ophthalmology. Hematopoietic stem cells have been used to treat corneal ulcers of different origin of several horses. These ulcers were resistant to conventional treatments available, but quickly responded positively to the stem cell treatment. Stem cells were also able to restore sight in one eye of a horse with retinal detachment, allowing the horse to return to daily activities.[72]

Pre-clinical models of Sjgrens syndrome [98][99] have culminated in allogeneic MSCs implanted around the lacrimal glands in KSC dogs that were refractory to current therapy. Significantly improved scores in ocular discharge, conjunctival hyperaemia, corneal changes and Schirmer tear tests (STT) were seen.[100]

In the late 1990s and early 2000s there was an initial wave of companies and clinics offering stem cell therapy to desperate people, often with extraordinary claims about what stem cells could do. Such companies and clinics included Advanced Cell Therapeutics, Stowe BioTherapy, Cells4Health run by Cornelis Kleinbloesem, the Beijing Xishan Institute for Neuroregeneration and Functional Recovery in Shijingshan run by Huang Hongyun, and EmCell in Kiev, Ukraine run by Alexandr Smikodub.[101][102] These clinics made strong claims about their outcomes, but rarely published their protocols or rigorous research showing that their therapies were safe and effective.[101]

By 2012 a second wave of companies and clinics had emerged, usually located in developing countries where medicine is less regulated and offering stem cell therapies on a medical tourism model.[102][103] Like the first wave companies and clinics, they have made similar strong claims and also have not published their protocols or rigorous research; Mexico, Thailand, and India have been centers of this activity,[102] as has South Africa.[103]

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Stem-cell therapy – Wikipedia

Stem Cell Therapy for Arthritis and Injuries | Regenexx

Select a Problem Area

If you have pain, we’re here to help. Regenexx Procedures are patented stem cell and blood platelet procedures that are used to treat a wide range of joint and spine conditions.

Click a problem area to discover what Regenexx can do for you.

The Regenexx family of non-surgical stem-cell & blood platelet procedures are next generation regenerative injection treatments for those who are suffering from shoulder pain due to arthritis, rotator cuff and shoulder labrum tears, overuse injuries, and other degenerative conditions. Regenexx is also a viable alternative for those considering shoulder replacement surgery.

View Details About Shoulder Treatments

Commonly Treated Conditions:

Shoulder Procedure Video

Regenexx Procedures are advanced stem cell and blood platelet procedures for foot and ankle conditions. Before you consider ankle surgery, fusion or replacement, consider the worlds leading stem cell and prp injection treatments.

View Details About Foot & Ankle Treatments

Commonly Treated Conditions:

Ankle Procedure Video

The Regenexx family of non-surgical stem-cell & blood platelet procedures are next generation regenerative injection treatments for those who are suffering from pain or reduced range of motion due to basal joint / cmc arthritis, hand arthritis, or other injuries & conditions in the hand.

View Details About Hand & Wrist Treatments

Commonly Treated Conditions:

The Regenexx family of non-surgical stem cell and blood platelet procedures offer next-generation injection treatments for those who are suffering from knee pain or may be facing knee surgery or knee replacement due to common injuries, arthritis, overuse and other conditions.

View Details About Knee Treatments

Commonly Treated Conditions:

ACL Procedure VideoIn-Depth with Dr. John Schultz ACL Procedure Video

The Regenexx family of non-surgical stem-cell & blood platelet procedures are next generation regenerative injection treatments for those who are suffering from pain, inflammation or reduced range of motion due tocommon elbow injuries, arthritis and overuse conditions.

View Details About Elbow Treatments

Commonly Treated Conditions:

The Regenexx family of hip surgery alternatives are breakthrough, non-surgical stem-cell treatments for people suffering from hip pain due to common injuries, hip arthritis & other degenerative problems related to the hip joint.

View Details About Hip Treatments

Commonly Treated Conditions:

Hip Labrum Procedure Video Hip Avascular Necrosis Procedure Video

Regenexx has many non-surgical platelet and stem cell based procedures developed to help patients avoid spine surgery and high dose epidural steroid side effects. These procedures utilize the patients own natural growth factors or stem cells to treat bulging or herniated discs, degenerative conditions in the spine, and other back and neck conditions that cause pain.

View Details About Spine Treatments

Commonly Treated Conditions:

Intradiscal Procedure Video

Regenexx has many non-surgical platelet and stem cell based procedures developed to help patients avoid spine surgery and high dose epidural steroid side effects. These procedures utilize the patients own natural growth factors or stem cells to treat bulging or herniated discs, degenerative conditions in the spine, and other back and neck conditions that cause pain.

View Details About Spine Treatments

Commonly Treated Conditions:

Cervical Spine Video

Follow this link:

Stem Cell Therapy for Arthritis and Injuries | Regenexx

Nine Things to Know About Stem Cell Treatments

Stem cells have tremendous promise to help us understand and treat a range of diseases, injuries and other health-related conditions. Their potential is evident in the use of blood stem cells to treat diseases of the blood, a therapy that has saved the lives of thousands of children with leukemia; and can be seen in the use of stem cells for tissue grafts to treat diseases or injury to the bone, skin and surface of the eye. Important clinical trials involving stem cells are underway for many other conditions and researchers continue to explore new avenues using stem cells in medicine.

There is still a lot to learn about stem cells, however, and their current applications as treatments are sometimes exaggerated by the media and other parties who do not fully understand the science and current limitations, and also by clinics looking to capitalize on the hype by selling treatments to chronically ill or seriously injured patients. The information on this page is intended to help you understand both the potential and the limitations of stem cells at this point in time, and to help you spot some of the misinformation that is widely circulated by clinics offering unproven treatments.

It is important to discuss these Nine Things to Know and any research or information you gather with your primary care physician and other trusted members of your healthcare team in deciding what is right for you.

Excerpt from:

Nine Things to Know About Stem Cell Treatments

Is Stem Cell Therapy for Arthritis Safe and Effective?

People considering stem cell treatment for arthritis want to know Is it safe? and Is it effective?

Most stem cell therapy using adult stem cells is considered safe because the stem cells are collected from the patient, minimizing the risk of an unwanted reaction. The most common side effects are temporary swelling and pain.3

While most stem cell therapy for arthritis is considered safe, it does carry the same risks as any other medical procedure, such as a small risk of infection. Risk may be increased if:

See What Are Stem Cells?

Some research suggests stem cell therapy engaging in these kinds of practices may elevate the risk of tumors.4

As with most regenerative medicine treatments, research is ongoing, and FDA regulations are relatively new and subject to change.

Article continues below

Whether or not stem cells therapy is effective in treating osteoarthritis is a controversial subject among medical professionals, and research in the area is ongoing.

See Osteoarthritis Treatment

How researchers think stem cell therapy worksResearchers theorize5 that when applied to an arthritic joint, stem cells might:

See Osteoarthritis Symptoms and Signs

It may be none, one, two, or all three processes at are work.

Proponents vs criticsLike many relatively new treatments, stem cell therapy has proponents and critics.

Critics emphasize that there have been no large-scale, prospective, double-blind research studiesthe kind of clinical studies that medical professionals consider the gold standardto support stem cell therapy for arthritis.

Factors that affect stem cell therapy researchAnother challenge associated with current stem cell research is that there is no standard stem cell therapy for arthritis treatment. So the stem cell therapy in one study is not necessarily the same as the stem cell therapy in another study.

Differences can include:

These differences are further complicated by more unknowns. For example, how many stem cells are needed for a particular treatment? And how do we determine if a patients own stem cells are competent enough to aid in healing?

Many physicians combine the use of stem cells with platelet rich plasma, or PRP.

See Platelet-Rich Plasma (PRP) Therapy for Arthritis

PRP is derived from a sample of the patients blood. In the body, platelets secrete substances called growth factors and other proteins that regulate cell division, stimulate tissue regeneration, and promote healing. Like stem cell therapy, PRP therapy is sometimes used alone with the hopes of healing an arthritic joint.

See PRP Injection Preparation and Composition

Physicians who use PRP and stem cells together think that the PRP can help maximize the healing effects of stem cells.7,8 Research in this area is ongoing.

See Platelet-Rich Plasma Injection Procedure

Stem cell therapy can vary depending on the doctor performing it. People considering stem cell therapy for an arthritic knee or other joint are advised to ask their doctors questions, including:

Both doctors and patients can benefit from having a frank conversation and setting reasonable expectations.

See Arthritis Treatment Specialists

Complete Listing of References

Read the original here:

Is Stem Cell Therapy for Arthritis Safe and Effective?

Stem Cell Therapy for Arthritis and Injuries | Regenexx

Select a Problem Area

If you have pain, we’re here to help. Regenexx Procedures are patented stem cell and blood platelet procedures that are used to treat a wide range of joint and spine conditions.

Click a problem area to discover what Regenexx can do for you.

The Regenexx family of non-surgical stem-cell & blood platelet procedures are next generation regenerative injection treatments for those who are suffering from shoulder pain due to arthritis, rotator cuff and shoulder labrum tears, overuse injuries, and other degenerative conditions. Regenexx is also a viable alternative for those considering shoulder replacement surgery.

View Details About Shoulder Treatments

Commonly Treated Conditions:

Shoulder Procedure Video

Regenexx Procedures are advanced stem cell and blood platelet procedures for foot and ankle conditions. Before you consider ankle surgery, fusion or replacement, consider the worlds leading stem cell and prp injection treatments.

View Details About Foot & Ankle Treatments

Commonly Treated Conditions:

Ankle Procedure Video

The Regenexx family of non-surgical stem-cell & blood platelet procedures are next generation regenerative injection treatments for those who are suffering from pain or reduced range of motion due to basal joint / cmc arthritis, hand arthritis, or other injuries & conditions in the hand.

View Details About Hand & Wrist Treatments

Commonly Treated Conditions:

The Regenexx family of non-surgical stem cell and blood platelet procedures offer next-generation injection treatments for those who are suffering from knee pain or may be facing knee surgery or knee replacement due to common injuries, arthritis, overuse and other conditions.

View Details About Knee Treatments

Commonly Treated Conditions:

ACL Procedure VideoIn-Depth with Dr. John Schultz ACL Procedure Video

The Regenexx family of non-surgical stem-cell & blood platelet procedures are next generation regenerative injection treatments for those who are suffering from pain, inflammation or reduced range of motion due tocommon elbow injuries, arthritis and overuse conditions.

View Details About Elbow Treatments

Commonly Treated Conditions:

The Regenexx family of hip surgery alternatives are breakthrough, non-surgical stem-cell treatments for people suffering from hip pain due to common injuries, hip arthritis & other degenerative problems related to the hip joint.

View Details About Hip Treatments

Commonly Treated Conditions:

Hip Labrum Procedure Video Hip Avascular Necrosis Procedure Video

Regenexx has many non-surgical platelet and stem cell based procedures developed to help patients avoid spine surgery and high dose epidural steroid side effects. These procedures utilize the patients own natural growth factors or stem cells to treat bulging or herniated discs, degenerative conditions in the spine, and other back and neck conditions that cause pain.

View Details About Spine Treatments

Commonly Treated Conditions:

Intradiscal Procedure Video

Regenexx has many non-surgical platelet and stem cell based procedures developed to help patients avoid spine surgery and high dose epidural steroid side effects. These procedures utilize the patients own natural growth factors or stem cells to treat bulging or herniated discs, degenerative conditions in the spine, and other back and neck conditions that cause pain.

View Details About Spine Treatments

Commonly Treated Conditions:

Cervical Spine Video

More:

Stem Cell Therapy for Arthritis and Injuries | Regenexx

Nine Things to Know About Stem Cell Treatments

Stem cells have tremendous promise to help us understand and treat a range of diseases, injuries and other health-related conditions. Their potential is evident in the use of blood stem cells to treat diseases of the blood, a therapy that has saved the lives of thousands of children with leukemia; and can be seen in the use of stem cells for tissue grafts to treat diseases or injury to the bone, skin and surface of the eye. Important clinical trials involving stem cells are underway for many other conditions and researchers continue to explore new avenues using stem cells in medicine.

There is still a lot to learn about stem cells, however, and their current applications as treatments are sometimes exaggerated by the media and other parties who do not fully understand the science and current limitations, and also by clinics looking to capitalize on the hype by selling treatments to chronically ill or seriously injured patients. The information on this page is intended to help you understand both the potential and the limitations of stem cells at this point in time, and to help you spot some of the misinformation that is widely circulated by clinics offering unproven treatments.

It is important to discuss these Nine Things to Know and any research or information you gather with your primary care physician and other trusted members of your healthcare team in deciding what is right for you.

Continue reading here:

Nine Things to Know About Stem Cell Treatments

Is Stem Cell Therapy for Arthritis Safe and Effective?

People considering stem cell treatment for arthritis want to know Is it safe? and Is it effective?

Most stem cell therapy using adult stem cells is considered safe because the stem cells are collected from the patient, minimizing the risk of an unwanted reaction. The most common side effects are temporary swelling and pain.3

While most stem cell therapy for arthritis is considered safe, it does carry the same risks as any other medical procedure, such as a small risk of infection. Risk may be increased if:

See What Are Stem Cells?

Some research suggests stem cell therapy engaging in these kinds of practices may elevate the risk of tumors.4

As with most regenerative medicine treatments, research is ongoing, and FDA regulations are relatively new and subject to change.

Article continues below

Whether or not stem cells therapy is effective in treating osteoarthritis is a controversial subject among medical professionals, and research in the area is ongoing.

See Osteoarthritis Treatment

How researchers think stem cell therapy worksResearchers theorize5 that when applied to an arthritic joint, stem cells might:

See Osteoarthritis Symptoms and Signs

It may be none, one, two, or all three processes at are work.

Proponents vs criticsLike many relatively new treatments, stem cell therapy has proponents and critics.

Critics emphasize that there have been no large-scale, prospective, double-blind research studiesthe kind of clinical studies that medical professionals consider the gold standardto support stem cell therapy for arthritis.

Factors that affect stem cell therapy researchAnother challenge associated with current stem cell research is that there is no standard stem cell therapy for arthritis treatment. So the stem cell therapy in one study is not necessarily the same as the stem cell therapy in another study.

Differences can include:

These differences are further complicated by more unknowns. For example, how many stem cells are needed for a particular treatment? And how do we determine if a patients own stem cells are competent enough to aid in healing?

Many physicians combine the use of stem cells with platelet rich plasma, or PRP.

See Platelet-Rich Plasma (PRP) Therapy for Arthritis

PRP is derived from a sample of the patients blood. In the body, platelets secrete substances called growth factors and other proteins that regulate cell division, stimulate tissue regeneration, and promote healing. Like stem cell therapy, PRP therapy is sometimes used alone with the hopes of healing an arthritic joint.

See PRP Injection Preparation and Composition

Physicians who use PRP and stem cells together think that the PRP can help maximize the healing effects of stem cells.7,8 Research in this area is ongoing.

See Platelet-Rich Plasma Injection Procedure

Stem cell therapy can vary depending on the doctor performing it. People considering stem cell therapy for an arthritic knee or other joint are advised to ask their doctors questions, including:

Both doctors and patients can benefit from having a frank conversation and setting reasonable expectations.

See Arthritis Treatment Specialists

Complete Listing of References

Here is the original post:

Is Stem Cell Therapy for Arthritis Safe and Effective?

Stem-cell therapy – Wikipedia

This article is about the medical therapy. For the cell type, see Stem cell.

Stem-cell therapy is the use of stem cells to treat or prevent a disease or condition.[1]

Bone marrow transplant is the most widely used stem-cell therapy, but some therapies derived from umbilical cord blood are also in use. Research is underway to develop various sources for stem cells, as well as to apply stem-cell treatments for neurodegenerative diseases and conditions such as diabetes and heart disease, among others.

Stem-cell therapy has become controversial following developments such as the ability of scientists to isolate and culture embryonic stem cells, to create stem cells using somatic cell nuclear transfer and their use of techniques to create induced pluripotent stem cells. This controversy is often related to abortion politics and to human cloning. Additionally, efforts to market treatments based on transplant of stored umbilical cord blood have been controversial.

For over 30 years, bone marrow has been used to treat cancer patients with conditions such as leukaemia and lymphoma; this is the only form of stem-cell therapy that is widely practiced.[2][3][4] During chemotherapy, most growing cells are killed by the cytotoxic agents. These agents, however, cannot discriminate between the leukaemia or neoplastic cells, and the hematopoietic stem cells within the bone marrow. It is this side effect of conventional chemotherapy strategies that the stem-cell transplant attempts to reverse; a donor’s healthy bone marrow reintroduces functional stem cells to replace the cells lost in the host’s body during treatment. The transplanted cells also generate an immune response that helps to kill off the cancer cells; this process can go too far, however, leading to graft vs host disease, the most serious side effect of this treatment.[5]

Another stem-cell therapy called Prochymal, was conditionally approved in Canada in 2012 for the management of acute graft-vs-host disease in children who are unresponsive to steroids.[6] It is an allogenic stem therapy based on mesenchymal stem cells (MSCs) derived from the bone marrow of adult donors. MSCs are purified from the marrow, cultured and packaged, with up to 10,000 doses derived from a single donor. The doses are stored frozen until needed.[7]

The FDA has approved five hematopoietic stem-cell products derived from umbilical cord blood, for the treatment of blood and immunological diseases.[8]

In 2014, the European Medicines Agency recommended approval of limbal stem cells for people with severe limbal stem cell deficiency due to burns in the eye.[9]

Stem cells are being studied for a number of reasons. The molecules and exosomes released from stem cells are also being studied in an effort to make medications.[10] The paracrine soluble factors produced by stem cells, known as the stem cell secretome, has been found to be the predominant mechanism by which stem cell-based therapies mediate their effects in degenerative, auto-immune and inflammatory diseases.[11]

Research has been conducted on the effects of stem cells on animal models of brain degeneration, such as in Parkinson’s, Amyotrophic lateral sclerosis, and Alzheimer’s disease.[12][13][14] There have been preliminary studies related to multiple sclerosis.[15][16]

Healthy adult brains contain neural stem cells which divide to maintain general stem-cell numbers, or become progenitor cells. In healthy adult laboratory animals, progenitor cells migrate within the brain and function primarily to maintain neuron populations for olfaction (the sense of smell). Pharmacological activation of endogenous neural stem cells has been reported to induce neuroprotection and behavioral recovery in adult rat models of neurological disorder.[17][18][19]

Stroke and traumatic brain injury lead to cell death, characterized by a loss of neurons and oligodendrocytes within the brain. Clinical and animal studies have been conducted into the use of stem cells in cases of spinal cord injury.[20][21][22]

Stems cells are studied in people with severe heart disease.[23] The work by Bodo-Eckehard Strauer[24] was discredited by identifying hundreds of factual contradictions.[25] Among several clinical trials reporting that adult stem cell therapy is safe and effective, actual evidence of benefit has been reported from only a few studies.[26] Some preliminary clinical trials achieved only modest improvements in heart function following use of bone marrow stem cell therapy.[27][28]

Stem-cell therapy for treatment of myocardial infarction usually makes use of autologous bone marrow stem cells, but other types of adult stem cells may be used, such as adipose-derived stem cells.[29]

Possible mechanisms of recovery include:[12]

In 2013, studies of autologous bone marrow stem cells on ventricular function were found to contain “hundreds” of discrepancies.[30] Critics report that of 48 reports there seemed to be just five underlying trials, and that in many cases whether they were randomized or merely observational accepter-versus-rejecter, was contradictory between reports of the same trial. One pair of reports of identical baseline characteristics and final results, was presented in two publications as, respectively, a 578 patient randomized trial and as a 391 patient observational study. Other reports required (impossible) negative standard deviations in subsets of patients, or contained fractional patients, negative NYHA classes. Overall there were many more patients published as having receiving stem cells in trials, than the number of stem cells processed in the hospital’s laboratory during that time. A university investigation, closed in 2012 without reporting, was reopened in July 2013.[31]

In 2014, a meta-analysis on stem cell therapy using bone marrow stem cells for heart disease revealed discrepancies in published clinical trial reports, whereby studies with a higher number of discrepancies showed an increase in effect sizes.[32] Another meta-analysis based on the intra-subject data of 12 randomised trials was unable to find any significant benefits of stem cell therapy on primary endpoints, such as major adverse events or increase in heart function measures, concluding there was no benefit.[33]

The TIME trial, which used a randomised, double blind, placebo-controlled trial design, concluded that “bone marrow mononuclear cells administration did not improve recovery of LV function over 2 years” in people who had a myocardial infarction.[34] Accordingly, the BOOST-2 trial conducted in 10 medical centres in Germany and Norway reported that the trial result “does not support the use of nucleated BMCs in patients with STEMI and moderately reduced LVEF”.[35] Furthermore, the trial also did not meet any other secondary MRI endpoints,[36] leading to a conclusion that intracoronary bone marrow stem cell therapy does not offer a functional or clinical benefit.[37]

The specificity of the human immune-cell repertoire is what allows the human body to defend itself from rapidly adapting antigens. However, the immune system is vulnerable to degradation upon the pathogenesis of disease, and because of the critical role that it plays in overall defense, its degradation is often fatal to the organism as a whole. Diseases of hematopoietic cells are diagnosed and classified via a subspecialty of pathology known as hematopathology. The specificity of the immune cells is what allows recognition of foreign antigens, causing further challenges in the treatment of immune disease. Identical matches between donor and recipient must be made for successful transplantation treatments, but matches are uncommon, even between first-degree relatives. Research using both hematopoietic adult stem cells and embryonic stem cells has provided insight into the possible mechanisms and methods of treatment for many of these ailments.[citation needed]

Fully mature human red blood cells may be generated ex vivo by hematopoietic stem cells (HSCs), which are precursors of red blood cells. In this process, HSCs are grown together with stromal cells, creating an environment that mimics the conditions of bone marrow, the natural site of red-blood-cell growth. Erythropoietin, a growth factor, is added, coaxing the stem cells to complete terminal differentiation into red blood cells.[38] Further research into this technique should have potential benefits to gene therapy, blood transfusion, and topical medicine.

In 2004, scientists at King’s College London discovered a way to cultivate a complete tooth in mice[39] and were able to grow bioengineered teeth stand-alone in the laboratory. Researchers are confident that the tooth regeneration technology can be used to grow live teeth in human patients.

In theory, stem cells taken from the patient could be coaxed in the lab turning into a tooth bud which, when implanted in the gums, will give rise to a new tooth, and would be expected to be grown in a time over three weeks.[40] It will fuse with the jawbone and release chemicals that encourage nerves and blood vessels to connect with it. The process is similar to what happens when humans grow their original adult teeth. Many challenges remain, however, before stem cells could be a choice for the replacement of missing teeth in the future.[41][42]

Heller has reported success in re-growing cochlea hair cells with the use of embryonic stem cells.[43]

Since 2003, researchers have successfully transplanted corneal stem cells into damaged eyes to restore vision. “Sheets of retinal cells used by the team are harvested from aborted fetuses, which some people find objectionable.” When these sheets are transplanted over the damaged cornea, the stem cells stimulate renewed repair, eventually restore vision.[44] The latest such development was in June 2005, when researchers at the Queen Victoria Hospital of Sussex, England were able to restore the sight of forty patients using the same technique. The group, led by Sheraz Daya, was able to successfully use adult stem cells obtained from the patient, a relative, or even a cadaver. Further rounds of trials are ongoing.[45]

Diabetes patients lose the function of insulin-producing beta cells within the pancreas.[46] In recent experiments, scientists have been able to coax embryonic stem cell to turn into beta cells in the lab. In theory if the beta cell is transplanted successfully, they will be able to replace malfunctioning ones in a diabetic patient.[47]

Clinical case reports in the treatment orthopaedic conditions have been reported. To date, the focus in the literature for musculoskeletal care appears to be on mesenchymal stem cells. Centeno et al. have published MRI evidence of increased cartilage and meniscus volume in individual human subjects.[48][unreliable medical source?][49] The results of trials that include a large number of subjects, are yet to be published. However, a published safety study conducted in a group of 227 patients over a 3-4-year period shows adequate safety and minimal complications associated with mesenchymal cell transplantation.[50]

Wakitani has also published a small case series of nine defects in five knees involving surgical transplantation of mesenchymal stem cells with coverage of the treated chondral defects.[51]

Stem cells can also be used to stimulate the growth of human tissues. In an adult, wounded tissue is most often replaced by scar tissue, which is characterized in the skin by disorganized collagen structure, loss of hair follicles and irregular vascular structure. In the case of wounded fetal tissue, however, wounded tissue is replaced with normal tissue through the activity of stem cells.[52] A possible method for tissue regeneration in adults is to place adult stem cell “seeds” inside a tissue bed “soil” in a wound bed and allow the stem cells to stimulate differentiation in the tissue bed cells. This method elicits a regenerative response more similar to fetal wound-healing than adult scar tissue formation.[52] Researchers are still investigating different aspects of the “soil” tissue that are conducive to regeneration.[52]

Culture of human embryonic stem cells in mitotically inactivated porcine ovarian fibroblasts (POF) causes differentiation into germ cells (precursor cells of oocytes and spermatozoa), as evidenced by gene expression analysis.[53]

Human embryonic stem cells have been stimulated to form Spermatozoon-like cells, yet still slightly damaged or malformed.[54] It could potentially treat azoospermia.

In 2012, oogonial stem cells were isolated from adult mouse and human ovaries and demonstrated to be capable of forming mature oocytes.[55] These cells have the potential to treat infertility.

Destruction of the immune system by the HIV is driven by the loss of CD4+ T cells in the peripheral blood and lymphoid tissues. Viral entry into CD4+ cells is mediated by the interaction with a cellular chemokine receptor, the most common of which are CCR5 and CXCR4. Because subsequent viral replication requires cellular gene expression processes, activated CD4+ cells are the primary targets of productive HIV infection.[56] Recently scientists have been investigating an alternative approach to treating HIV-1/AIDS, based on the creation of a disease-resistant immune system through transplantation of autologous, gene-modified (HIV-1-resistant) hematopoietic stem and progenitor cells (GM-HSPC).[57]

Stem cells are thought to mediate repair via five primary mechanisms: 1) providing an anti-inflammatory effect, 2) homing to damaged tissues and recruiting other cells, such as endothelial progenitor cells, that are necessary for tissue growth, 3) supporting tissue remodeling over scar formation, 4) inhibiting apoptosis, and 5) differentiating into bone, cartilage, tendon, and ligament tissue.[58][59]

To further enrich blood supply to the damaged areas, and consequently promote tissue regeneration, platelet-rich plasma could be used in conjunction with stem cell transplantation.[60][61] The efficacy of some stem cell populations may also be affected by the method of delivery; for instance, to regenerate bone, stem cells are often introduced in a scaffold where they produce the minerals necessary for generation of functional bone.[60][61][62][63]

Stem cells have also been shown to have a low immunogenicity due to the relatively low number of MHC molecules found on their surface. In addition, they have been found to secrete chemokines that alter the immune response and promote tolerance of the new tissue. This allows for allogeneic treatments to be performed without a high rejection risk.[64]

The ability to grow up functional adult tissues indefinitely in culture through Directed differentiation creates new opportunities for drug research. Researchers are able to grow up differentiated cell lines and then test new drugs on each cell type to examine possible interactions in vitro before performing in vivo studies. This is critical in the development of drugs for use in veterinary research because of the possibilities of species specific interactions. The hope is that having these cell lines available for research use will reduce the need for research animals used because effects on human tissue in vitro will provide insight not normally known before the animal testing phase.[65]

Stem cells are being explored for use in conservation efforts. Spermatogonial stem cells have been harvested from a rat and placed into a mouse host and fully mature sperm were produced with the ability to produce viable offspring. Currently research is underway to find suitable hosts for the introduction of donor spermatogonial stem cells. If this becomes a viable option for conservationists, sperm can be produced from high genetic quality individuals who die before reaching sexual maturity, preserving a line that would otherwise be lost.[66]

Most stem cells intended for regenerative therapy are generally isolated either from the patient’s bone marrow or from adipose tissue.[61][63] Mesenchymal stem cells can differentiate into the cells that make up bone, cartilage, tendons, and ligaments, as well as muscle, neural and other progenitor tissues, they have been the main type of stem cells studied in the treatment of diseases affecting these tissues.[67][68] The number of stem cells transplanted into damaged tissue may alter efficacy of treatment. Accordingly, stem cells derived from bone marrow aspirates, for instance, are cultured in specialized laboratories for expansion to millions of cells.[61][63] Although adipose-derived tissue also requires processing prior to use, the culturing methodology for adipose-derived stem cells is not as extensive as that for bone marrow-derived cells.[69][70] While it is thought that bone-marrow derived stem cells are preferred for bone, cartilage, ligament, and tendon repair, others believe that the less challenging collection techniques and the multi-cellular microenvironment already present in adipose-derived stem cell fractions make the latter the preferred source for autologous transplantation.[60]

New sources of mesenchymal stem cells are being researched, including stem cells present in the skin and dermis which are of interest because of the ease at which they can be harvested with minimal risk to the animal.[71] Hematopoetic stem cells have also been discovered to be travelling in the blood stream and possess equal differentiating ability as other mesenchymal stem cells, again with a very non-invasive harvesting technique.[72]

There is widespread controversy over the use of human embryonic stem cells. This controversy primarily targets the techniques used to derive new embryonic stem cell lines, which often requires the destruction of the blastocyst. Opposition to the use of human embryonic stem cells in research is often based on philosophical, moral, or religious objections.[73] There is other stem cell research that does not involve the destruction of a human embryo, and such research involves adult stem cells, amniotic stem cells, and induced pluripotent stem cells.

On 23 January 2009, the US Food and Drug Administration gave clearance to Geron Corporation for the initiation of the first clinical trial of an embryonic stem-cell-based therapy on humans. The trial aimed evaluate the drug GRNOPC1, embryonic stem cell-derived oligodendrocyte progenitor cells, on patients with acute spinal cord injury. The trial was discontinued in November 2011 so that the company could focus on therapies in the “current environment of capital scarcity and uncertain economic conditions”.[74] In 2013 biotechnology and regenerative medicine company BioTime (AMEX:BTX) acquired Geron’s stem cell assets in a stock transaction, with the aim of restarting the clinical trial.[75]

Scientists have reported that MSCs when transfused immediately within few hours post thawing may show reduced function or show decreased efficacy in treating diseases as compared to those MSCs which are in log phase of cell growth(fresh), so cryopreserved MSCs should be brought back into log phase of cell growth in invitro culture before these are administered for clinical trials or experimental therapies, re-culturing of MSCs will help in recovering from the shock the cells get during freezing and thawing. Various clinical trials on MSCs have failed which used cryopreserved product immediately post thaw as compared to those clinical trials which used fresh MSCs.[76]

Research has been conducted on horses, dogs, and cats can benefit the development of stem cell treatments in veterinary medicine and can target a wide range of injuries and diseases such as myocardial infarction, stroke, tendon and ligament damage, osteoarthritis, osteochondrosis and muscular dystrophy both in large animals, as well as humans.[77][78][79][80] While investigation of cell-based therapeutics generally reflects human medical needs, the high degree of frequency and severity of certain injuries in racehorses has put veterinary medicine at the forefront of this novel regenerative approach.[81] Companion animals can serve as clinically relevant models that closely mimic human disease.[82][83]

Veterinary applications of stem cell therapy as a means of tissue regeneration have been largely shaped by research that began with the use of adult-derived mesenchymal stem cells to treat animals with injuries or defects affecting bone, cartilage, ligaments and/or tendons.[84][67][85] There are two main categories of stem cells used for treatments: allogeneic stem cells derived from a genetically different donor within the same species[63][86] and autologous mesenchymal stem cells, derived from the patient prior to use in various treatments.[60] A third category, xenogenic stem cells, or stem cells derived from different species, are used primarily for research purposes, especially for human treatments.[65]

Bone has a unique and well documented natural healing process that normally is sufficient to repair fractures and other common injuries. Misaligned breaks due to severe trauma, as well as treatments like tumor resections of bone cancer, are prone to improper healing if left to the natural process alone. Scaffolds composed of natural and artificial components are seeded with mesenchymal stem cells and placed in the defect. Within four weeks of placing the scaffold, newly formed bone begins to integrate with the old bone and within 32 weeks, full union is achieved.[87] Further studies are necessary to fully characterize the use of cell-based therapeutics for treatment of bone fractures.

Stem cells have been used to treat degenerative bone diseases. The normally recommended treatment for dogs that have LeggCalvePerthes disease is to remove the head of the femur after the degeneration has progressed. Recently, mesenchymal stem cells have been injected directly in to the head of the femur, with success not only in bone regeneration, but also in pain reduction.[87]

Because of the general positive healing capabilities of stem cells, they have gained interest for the treatment of cutaneous wounds. This is important interest for those with reduced healing capabilities, like diabetics and those undergoing chemotherapy. In one trial, stem cells were isolated from the Wharton’s jelly of the umbilical cord. These cells were injected directly into the wounds. Within a week, full re-epithelialization of the wounds had occurred, compared to minor re-epithelialization in the control wounds. This showed the capabilities of mesenchymal stem cells in the repair of epidermal tissues.[88]

Soft-palate defects in horses are caused by a failure of the embryo to fully close at the midline during embryogenesis. These are often not found until after they have become worse because of the difficulty in visualizing the entire soft palate. This lack of visualization is thought to also contribute to the low success rate in surgical intervention to repair the defect. As a result, the horse often has to be euthanized. Recently, the use of mesenchymal stem cells has been added to the conventional treatments. After the surgeon has sutured the palate closed, autologous mesenchymal cells are injected into the soft palate. The stem cells were found to be integrated into the healing tissue especially along the border with the old tissue. There was also a large reduction in the number of inflammatory cells present, which is thought to aid in the healing process.[89]

Autologous stem cell-based treatments for ligament injury, tendon injury, osteoarthritis, osteochondrosis, and sub-chondral bone cysts have been commercially available to practicing veterinarians to treat horses since 2003 in the United States and since 2006 in the United Kingdom. Autologous stem cell based treatments for tendon injury, ligament injury, and osteoarthritis in dogs have been available to veterinarians in the United States since 2005. Over 3000 privately owned horses and dogs have been treated with autologous adipose-derived stem cells. The efficacy of these treatments has been shown in double-blind clinical trials for dogs with osteoarthritis of the hip and elbow and horses with tendon damage.[90][91]

Race horses are especially prone to injuries of the tendon and ligaments. Conventional therapies are very unsuccessful in returning the horse to full functioning potential. Natural healing, guided by the conventional treatments, leads to the formation of fibrous scar tissue that reduces flexibility and full joint movement. Traditional treatments prevented a large number of horses from returning to full activity and also have a high incidence of re-injury due to the stiff nature of the scarred tendon. Introduction of both bone marrow and adipose derived stem cells, along with natural mechanical stimulus promoted the regeneration of tendon tissue. The natural movement promoted the alignment of the new fibers and tendocytes with the natural alignment found in uninjured tendons. Stem cell treatment not only allowed more horses to return to full duty and also greatly reduced the re-injury rate over a three-year period.[64]

The use of embryonic stem cells has also been applied to tendon repair. The embryonic stem cells were shown to have a better survival rate in the tendon as well as better migrating capabilities to reach all areas of damaged tendon. The overall repair quality was also higher, with better tendon architecture and collagen formed. There was also no tumor formation seen during the three-month experimental period. Long-term studies need to be carried out to examine the long-term efficacy and risks associated with the use of embryonic stem cells.[64] Similar results have been found in small animals.[64]

Osteoarthritis is the main cause of joint pain both in animals and humans. Horses and dogs are most frequently affected by arthritis. Natural cartilage regeneration is very limited and no current drug therapies are curative, but rather look to reduce the symptoms associated with the degeneration. Different types of mesenchymal stem cells and other additives are still being researched to find the best type of cell and method for long-term treatment.[64]

Adipose-derived mesenchymal cells are currently the most often used because of the non-invasive harvesting. There has been a lot of success recently injecting mesenchymal stem cells directly into the joint. This is a recently developed, non-invasive technique developed for easier clinical use. Dogs receiving this treatment showed greater flexibility in their joints and less pain.[92]

Stem cells have successfully been used to ameliorate healing in the heart after myocardial infarction in dogs. Adipose and bone marrow derived stem cells were removed and induced to a cardiac cell fate before being injected into the heart. The heart was found to have improved contractility and a reduction in the damaged area four weeks after the stem cells were applied.[93]

A different trial is underway for a patch made of a porous substance onto which the stem cells are “seeded” in order to induce tissue regeneration in heart defects. Tissue was regenerated and the patch was well incorporated into the heart tissue. This is thought to be due, in part, to improved angiogenesis and reduction of inflammation. Although cardiomyocytes were produced from the mesenchymal stem cells, they did not appear to be contractile. Other treatments that induced a cardiac fate in the cells before transplanting had greater success at creating contractile heart tissue.[94]

Spinal cord injuries are one of the most common traumas brought into veterinary hospitals.[87] Spinal injuries occur in two ways after the trauma: the primary mechanical damage, and in secondary processes, like inflammation and scar formation, in the days following the trauma. These cells involved in the secondary damage response secrete factors that promote scar formation and inhibit cellular regeneration. Mesenchymal stem cells that are induced to a neural cell fate are loaded onto a porous scaffold and are then implanted at the site of injury. The cells and scaffold secrete factors that counteract those secreted by scar forming cells and promote neural regeneration. Eight weeks later, dogs treated with stem cells showed immense improvement over those treated with conventional therapies. Dogs treated with stem cells were able to occasionally support their own weight, which has not been seen in dogs undergoing conventional therapies.[95][96][97]

Treatments are also in clinical trials to repair and regenerate peripheral nerves. Peripheral nerves are more likely to be damaged, but the effects of the damage are not as widespread as seen in injuries to the spinal cord. Treatments are currently in clinical trials to repair severed nerves, with early success. Stem cells induced to a neural fate injected in to a severed nerve. Within four weeks, regeneration of previously damaged stem cells and completely formed nerve bundles were observed.[71]

Stem cells are also in clinical phases for treatment in ophthalmology. Hematopoietic stem cells have been used to treat corneal ulcers of different origin of several horses. These ulcers were resistant to conventional treatments available, but quickly responded positively to the stem cell treatment. Stem cells were also able to restore sight in one eye of a horse with retinal detachment, allowing the horse to return to daily activities.[72]

Pre-clinical models of Sjgrens syndrome [98][99] have culminated in allogeneic MSCs implanted around the lacrimal glands in KSC dogs that were refractory to current therapy. Significantly improved scores in ocular discharge, conjunctival hyperaemia, corneal changes and Schirmer tear tests (STT) were seen.[100]

In the late 1990s and early 2000s there was an initial wave of companies and clinics offering stem cell therapy to desperate people, often with extraordinary claims about what stem cells could do. Such companies and clinics included Advanced Cell Therapeutics, Stowe BioTherapy, Cells4Health run by Cornelis Kleinbloesem, the Beijing Xishan Institute for Neuroregeneration and Functional Recovery in Shijingshan run by Huang Hongyun, and EmCell in Kiev, Ukraine run by Alexandr Smikodub.[101][102] These clinics made strong claims about their outcomes, but rarely published their protocols or rigorous research showing that their therapies were safe and effective.[101]

By 2012 a second wave of companies and clinics had emerged, usually located in developing countries where medicine is less regulated and offering stem cell therapies on a medical tourism model.[102][103] Like the first wave companies and clinics, they have made similar strong claims and also have not published their protocols or rigorous research; Mexico, Thailand, and India have been centers of this activity,[102] as has South Africa.[103]

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Stem-cell therapy – Wikipedia

Stem cell – Wikipedia

Stem cells are biological cells that can differentiate into other types of cells and can divide to produce more of the same type of stem cells. They are found in multicellular organisms.

In mammals, there are two broad types of stem cells: embryonic stem cells, which are isolated from the inner cell mass of blastocysts, and adult stem cells, which are found in various tissues. In adult organisms, stem cells and progenitor cells act as a repair system for the body, replenishing adult tissues. In a developing embryo, stem cells can differentiate into all the specialized cellsectoderm, endoderm and mesoderm (see induced pluripotent stem cells)but also maintain the normal turnover of regenerative organs, such as blood, skin, or intestinal tissues.

There are three known accessible sources of autologous adult stem cells in humans:

Stem cells can also be taken from umbilical cord blood just after birth. Of all stem cell types, autologous harvesting involves the least risk. By definition, autologous cells are obtained from one’s own body, just as one may bank his or her own blood for elective surgical procedures.

Adult stem cells are frequently used in various medical therapies (e.g., bone marrow transplantation). Stem cells can now be artificially grown and transformed (differentiated) into specialized cell types with characteristics consistent with cells of various tissues such as muscles or nerves. Embryonic cell lines and autologous embryonic stem cells generated through somatic cell nuclear transfer or dedifferentiation have also been proposed as promising candidates for future therapies.[1] Research into stem cells grew out of findings by Ernest A. McCulloch and James E. Till at the University of Toronto in the 1960s.[2][3]

The classical definition of a stem cell requires that it possesses two properties:

Two mechanisms exist to ensure that a stem cell population is maintained:

1. Obligatory asymmetric replication: a stem cell divides into one mother cell that is identical to the original stem cell, and another daughter cell that is differentiated.

When a stem cell self-renews it divides and does not disrupt the undifferentiated state. This self-renewal demands control of cell cycle as well as upkeep of multipotency or pluripotency, which all depends on the stem cell.[4]

2. Stochastic differentiation: when one stem cell develops into two differentiated daughter cells, another stem cell undergoes mitosis and produces two stem cells identical to the original.

Potency specifies the differentiation potential (the potential to differentiate into different cell types) of the stem cell.[5]

In practice, stem cells are identified by whether they can regenerate tissue. For example, the defining test for bone marrow or hematopoietic stem cells (HSCs) is the ability to transplant the cells and save an individual without HSCs. This demonstrates that the cells can produce new blood cells over a long term. It should also be possible to isolate stem cells from the transplanted individual, which can themselves be transplanted into another individual without HSCs, demonstrating that the stem cell was able to self-renew.

Properties of stem cells can be illustrated in vitro, using methods such as clonogenic assays, in which single cells are assessed for their ability to differentiate and self-renew.[8][9] Stem cells can also be isolated by their possession of a distinctive set of cell surface markers. However, in vitro culture conditions can alter the behavior of cells, making it unclear whether the cells shall behave in a similar manner in vivo. There is considerable debate as to whether some proposed adult cell populations are truly stem cells.[citation needed]

Embryonic stem (ES) cells are the cells of the inner cell mass of a blastocyst, an early-stage embryo.[10] Human embryos reach the blastocyst stage 45 days post fertilization, at which time they consist of 50150 cells. ES cells are pluripotent and give rise during development to all derivatives of the three primary germ layers: ectoderm, endoderm and mesoderm. In other words, they can develop into each of the more than 200 cell types of the adult body when given sufficient and necessary stimulation for a specific cell type. They do not contribute to the extra-embryonic membranes or the placenta.

During embryonic development these inner cell mass cells continuously divide and become more specialized. For example, a portion of the ectoderm in the dorsal part of the embryo specializes as ‘neurectoderm’, which will become the future central nervous system.[11] Later in development, neurulation causes the neurectoderm to form the neural tube. At the neural tube stage, the anterior portion undergoes encephalization to generate or ‘pattern’ the basic form of the brain. At this stage of development, the principal cell type of the CNS is considered a neural stem cell. These neural stem cells are pluripotent, as they can generate a large diversity of many different neuron types, each with unique gene expression, morphological, and functional characteristics. The process of generating neurons from stem cells is called neurogenesis. One prominent example of a neural stem cell is the radial glial cell, so named because it has a distinctive bipolar morphology with highly elongated processes spanning the thickness of the neural tube wall, and because historically it shared some glial characteristics, most notably the expression of glial fibrillary acidic protein (GFAP).[12][13] The radial glial cell is the primary neural stem cell of the developing vertebrate CNS, and its cell body resides in the ventricular zone, adjacent to the developing ventricular system. Neural stem cells are committed to the neuronal lineages (neurons, astrocytes, and oligodendrocytes), and thus their potency is restricted.[11]

Nearly all research to date has made use of mouse embryonic stem cells (mES) or human embryonic stem cells (hES) derived from the early inner cell mass. Both have the essential stem cell characteristics, yet they require very different environments in order to maintain an undifferentiated state. Mouse ES cells are grown on a layer of gelatin as an extracellular matrix (for support) and require the presence of leukemia inhibitory factor (LIF) in serum media. A drug cocktail containing inhibitors to GSK3B and the MAPK/ERK pathway, called 2i, has also been shown to maintain pluripotency in stem cell culture.[14] Human ES cells are grown on a feeder layer of mouse embryonic fibroblasts (MEFs) and require the presence of basic fibroblast growth factor (bFGF or FGF-2).[15] Without optimal culture conditions or genetic manipulation,[16] embryonic stem cells will rapidly differentiate.

A human embryonic stem cell is also defined by the expression of several transcription factors and cell surface proteins. The transcription factors Oct-4, Nanog, and Sox2 form the core regulatory network that ensures the suppression of genes that lead to differentiation and the maintenance of pluripotency.[17] The cell surface antigens most commonly used to identify hES cells are the glycolipids stage specific embryonic antigen 3 and 4 and the keratan sulfate antigens Tra-1-60 and Tra-1-81. By using human embryonic stem cells to produce specialized cells like nerve cells or heart cells in the lab, scientists can gain access to adult human cells without taking tissue from patients. They can then study these specialized adult cells in detail to try and catch complications of diseases, or to study cells reactions to potentially new drugs. The molecular definition of a stem cell includes many more proteins and continues to be a topic of research.[18]

There are currently no approved treatments using embryonic stem cells. The first human trial was approved by the US Food and Drug Administration in January 2009.[19] However, the human trial was not initiated until October 13, 2010 in Atlanta for spinal cord injury research. On November 14, 2011 the company conducting the trial (Geron Corporation) announced that it will discontinue further development of its stem cell programs.[20] ES cells, being pluripotent cells, require specific signals for correct differentiationif injected directly into another body, ES cells will differentiate into many different types of cells, causing a teratoma. Differentiating ES cells into usable cells while avoiding transplant rejection are just a few of the hurdles that embryonic stem cell researchers still face.[21] Due to ethical considerations, many nations currently have moratoria or limitations on either human ES cell research or the production of new human ES cell lines. Because of their combined abilities of unlimited expansion and pluripotency, embryonic stem cells remain a theoretically potential source for regenerative medicine and tissue replacement after injury or disease.[22]

Human embryonic stem cell colony on mouse embryonic fibroblast feeder layer

The primitive stem cells located in the organs of fetuses are referred to as fetal stem cells.[23]There are two types of fetal stem cells:

Adult stem cells, also called somatic (from Greek , “of the body”) stem cells, are stem cells which maintain and repair the tissue in which they are found.[25] They can be found in children, as well as adults.[26]

Pluripotent adult stem cells are rare and generally small in number, but they can be found in umbilical cord blood and other tissues.[27] Bone marrow is a rich source of adult stem cells,[28] which have been used in treating several conditions including liver cirrhosis,[29] chronic limb ischemia [30] and endstage heart failure.[31] The quantity of bone marrow stem cells declines with age and is greater in males than females during reproductive years.[32] Much adult stem cell research to date has aimed to characterize their potency and self-renewal capabilities.[33] DNA damage accumulates with age in both stem cells and the cells that comprise the stem cell environment. This accumulation is considered to be responsible, at least in part, for increasing stem cell dysfunction with aging (see DNA damage theory of aging).[34]

Most adult stem cells are lineage-restricted (multipotent) and are generally referred to by their tissue origin (mesenchymal stem cell, adipose-derived stem cell, endothelial stem cell, dental pulp stem cell, etc.).[35][36] Muse cells (multi-lineage differentiating stress enduring cells) are a recently discovered pluripotent stem cell type found in multiple adult tissues, including adipose, dermal fibroblasts, and bone marrow. While rare, muse cells are identifiable by their expression of SSEA-3, a marker for undifferentiated stem cells, and general mesenchymal stem cells markers such as CD105. When subjected to single cell suspension culture, the cells will generate clusters that are similar to embryoid bodies in morphology as well as gene expression, including canonical pluripotency markers Oct4, Sox2, and Nanog.[37]

Adult stem cell treatments have been successfully used for many years to treat leukemia and related bone/blood cancers through bone marrow transplants.[38] Adult stem cells are also used in veterinary medicine to treat tendon and ligament injuries in horses.[39]

The use of adult stem cells in research and therapy is not as controversial as the use of embryonic stem cells, because the production of adult stem cells does not require the destruction of an embryo. Additionally, in instances where adult stem cells are obtained from the intended recipient (an autograft), the risk of rejection is essentially non-existent. Consequently, more US government funding is being provided for adult stem cell research.[40]

Multipotent stem cells are also found in amniotic fluid. These stem cells are very active, expand extensively without feeders and are not tumorigenic. Amniotic stem cells are multipotent and can differentiate in cells of adipogenic, osteogenic, myogenic, endothelial, hepatic and also neuronal lines.[41]Amniotic stem cells are a topic of active research.

Use of stem cells from amniotic fluid overcomes the ethical objections to using human embryos as a source of cells. Roman Catholic teaching forbids the use of embryonic stem cells in experimentation; accordingly, the Vatican newspaper “Osservatore Romano” called amniotic stem cells “the future of medicine”.[42]

It is possible to collect amniotic stem cells for donors or for autologuous use: the first US amniotic stem cells bank [43][44] was opened in 2009 in Medford, MA, by Biocell Center Corporation[45][46][47] and collaborates with various hospitals and universities all over the world.[48]

Adult stem cells have limitations with their potency; unlike ESCs, they are not able to differentiate into cells from all three germ layers. As such, they are deemed multipotent.

However, reprogramming allows for the creation of pluripotent cells, induced pluripotent stem cells, from adult cells. It is important to note that these are not adult stem cells, but adult cells (e.g. epithelial cells) reprogrammed to give rise to cells with pluripotent capabilities. Using genetic reprogramming with protein transcription factors, pluripotent stem cells with ESC-like capabilities have been derived.[49][50][51] The first demonstration of Induced Pluripotent Stem Cells was conducted by Shinya Yamanaka and his colleagues at Kyoto University.[52] They used the transcription factors Oct3/4, Sox2, c-Myc, and Klf4 to reprogram mouse fibroblast cells into pluripotent cells.[49][53] Subsequent work used these factors to induce pluripotency in human fibroblast cells.[54] Junying Yu, James Thomson, and their colleagues at the University of WisconsinMadison used a different set of factors, Oct4, Sox2, Nanog and Lin28, and carried out their experiments using cells from human foreskin.[49][55] However, they were able to replicate Yamanaka’s finding that inducing pluripotency in human cells was possible.

It is important to note that iPSCs and ESCs are not equivalent. They have many similar properties, such as pluripotency and differentiation potential, the expression of pluripotency genes, epigenetic patterns, embryoid body and teratoma formation, and viable chimera formation.[52][53] However, similar does not mean they are the same. In fact, there are many differences within these properties. Importantly, the chromatin of iPSCs appears to be more “closed” or methylated than that of ESCs.[52][53] Similarly, the gene expression pattern between ESCs and iPSCs, or even iPSCs sourced from different origins.[52] There are thus questions about the “completeness” of reprogramming and the somatic memory of induced pluripotent stem cells. Despite this, inducing adult cells to be pluripotent appears to be viable.

As a result of the success of these experiments, Ian Wilmut, who helped create the first cloned animal Dolly the Sheep, has announced that he will abandon somatic cell nuclear transfer as an avenue of research.[56]

Furthermore, induced pluripotent stem cells provide several therapeutic advantages. Like ESCs, they are pluripotent. They thus have great differentiation potential; theoretically, they could produce any cell within the human body (if reprogramming to pluripotency was “complete”).[52] Moreover, unlike ESCs, they potentially could allow doctors to create a pluripotent stem cell line for each individual patient.[57] In fact, frozen blood samples can be used as a source of induced pluripotent stem cells, opening a new avenue for obtaining the valued cells.[58] Patient specific stem cells allow for the screening for side effects before drug treatment, as well as the reduced risk of transplantation rejection.[57] Despite their current limited use therapeutically, iPSCs hold create potential for future use in medical treatment and research.

To ensure self-renewal, stem cells undergo two types of cell division (see Stem cell division and differentiation diagram). Symmetric division gives rise to two identical daughter cells both endowed with stem cell properties. Asymmetric division, on the other hand, produces only one stem cell and a progenitor cell with limited self-renewal potential. Progenitors can go through several rounds of cell division before terminally differentiating into a mature cell. It is possible that the molecular distinction between symmetric and asymmetric divisions lies in differential segregation of cell membrane proteins (such as receptors) between the daughter cells.[59]

An alternative theory is that stem cells remain undifferentiated due to environmental cues in their particular niche. Stem cells differentiate when they leave that niche or no longer receive those signals. Studies in Drosophila germarium have identified the signals decapentaplegic and adherens junctions that prevent germarium stem cells from differentiating.[60][61]

Stem cell therapy is the use of stem cells to treat or prevent a disease or condition. Bone marrow transplant is a form of stem cell therapy that has been used for many years without controversy.[62][63]

Stem cell treatments may lower symptoms of the disease or condition that is being treated. The lowering of symptoms may allow patients to reduce the drug intake of the disease or condition. Stem cell treatment may also provide knowledge for society to further stem cell understanding and future treatments.[64]

Stem cell treatments may require immunosuppression because of a requirement for radiation before the transplant to remove the person’s previous cells, or because the patient’s immune system may target the stem cells. One approach to avoid the second possibility is to use stem cells from the same patient who is being treated.

Pluripotency in certain stem cells could also make it difficult to obtain a specific cell type. It is also difficult to obtain the exact cell type needed, because not all cells in a population differentiate uniformly. Undifferentiated cells can create tissues other than desired types.[65]

Some stem cells form tumors after transplantation;[66] pluripotency is linked to tumor formation especially in embryonic stem cells, fetal proper stem cells, induced pluripotent stem cells. Fetal proper stem cells form tumors despite multipotency.[67]

Some of the fundamental patents covering human embryonic stem cells are owned by the Wisconsin Alumni Research Foundation (WARF) they are patents 5,843,780, 6,200,806, and 7,029,913 invented by James A. Thomson. WARF does not enforce these patents against academic scientists, but does enforce them against companies.[68]

In 2006, a request for the US Patent and Trademark Office (USPTO) to re-examine the three patents was filed by the Public Patent Foundation on behalf of its client, the non-profit patent-watchdog group Consumer Watchdog (formerly the Foundation for Taxpayer and Consumer Rights).[68] In the re-examination process, which involves several rounds of discussion between the USPTO and the parties, the USPTO initially agreed with Consumer Watchdog and rejected all the claims in all three patents,[69] however in response, WARF amended the claims of all three patents to make them more narrow, and in 2008 the USPTO found the amended claims in all three patents to be patentable. The decision on one of the patents (7,029,913) was appealable, while the decisions on the other two were not.[70][71] Consumer Watchdog appealed the granting of the ‘913 patent to the USPTO’s Board of Patent Appeals and Interferences (BPAI) which granted the appeal, and in 2010 the BPAI decided that the amended claims of the ‘913 patent were not patentable.[72] However, WARF was able to re-open prosecution of the case and did so, amending the claims of the ‘913 patent again to make them more narrow, and in January 2013 the amended claims were allowed.[73]

In July 2013, Consumer Watchdog announced that it would appeal the decision to allow the claims of the ‘913 patent to the US Court of Appeals for the Federal Circuit (CAFC), the federal appeals court that hears patent cases.[74] At a hearing in December 2013, the CAFC raised the question of whether Consumer Watchdog had legal standing to appeal; the case could not proceed until that issue was resolved.[75]

Diseases and conditions where stem cell treatment is being investigated include:

Research is underway to develop various sources for stem cells, and to apply stem cell treatments for neurodegenerative diseases and conditions, diabetes, heart disease, and other conditions.[91] Research is also underway in generating organoids using stem cells, which would allow for further understanding of human development, organogenesis, and modeling of human diseases.[92]

In more recent years, with the ability of scientists to isolate and culture embryonic stem cells, and with scientists’ growing ability to create stem cells using somatic cell nuclear transfer and techniques to create induced pluripotent stem cells, controversy has crept in, both related to abortion politics and to human cloning.

Hepatotoxicity and drug-induced liver injury account for a substantial number of failures of new drugs in development and market withdrawal, highlighting the need for screening assays such as stem cell-derived hepatocyte-like cells, that are capable of detecting toxicity early in the drug development process.[93]

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Stem cell – Wikipedia

Stem Cell Treatment | Arizona | Stem Cell Rejuvenation Center

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Please Note: Although we have supplied links to the research journals above on the use of stem cells for specific conditions, we are not saying that any of these studies would relate to your particular condition, nor that it would even be an effective treatment. OurAutologousStem Cell Therapy is not an FDA approved treatment for any condition. We provide stem cell therapy (less than manipulated) as a service &as a practice of medicine only. Please see theFAQ pagefor more information. Thesejournal articlesare for educational purposes only &are not intended to be used to sell or promote our therapy.

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Is Stem Cell Therapy for Arthritis Safe and Effective?

People considering stem cell treatment for arthritis want to know Is it safe? and Is it effective?

Most stem cell therapy using adult stem cells is considered safe because the stem cells are collected from the patient, minimizing the risk of an unwanted reaction. The most common side effects are temporary swelling and pain.3

While most stem cell therapy for arthritis is considered safe, it does carry the same risks as any other medical procedure, such as a small risk of infection. Risk may be increased if:

See What Are Stem Cells?

Some research suggests stem cell therapy engaging in these kinds of practices may elevate the risk of tumors.4

As with most regenerative medicine treatments, research is ongoing, and FDA regulations are relatively new and subject to change.

Article continues below

Whether or not stem cells therapy is effective in treating osteoarthritis is a controversial subject among medical professionals, and research in the area is ongoing.

See Osteoarthritis Treatment

How researchers think stem cell therapy worksResearchers theorize5 that when applied to an arthritic joint, stem cells might:

See Osteoarthritis Symptoms and Signs

It may be none, one, two, or all three processes at are work.

Proponents vs criticsLike many relatively new treatments, stem cell therapy has proponents and critics.

Critics emphasize that there have been no large-scale, prospective, double-blind research studiesthe kind of clinical studies that medical professionals consider the gold standardto support stem cell therapy for arthritis.

Factors that affect stem cell therapy researchAnother challenge associated with current stem cell research is that there is no standard stem cell therapy for arthritis treatment. So the stem cell therapy in one study is not necessarily the same as the stem cell therapy in another study.

Differences can include:

These differences are further complicated by more unknowns. For example, how many stem cells are needed for a particular treatment? And how do we determine if a patients own stem cells are competent enough to aid in healing?

Many physicians combine the use of stem cells with platelet rich plasma, or PRP.

See Platelet-Rich Plasma (PRP) Therapy for Arthritis

PRP is derived from a sample of the patients blood. In the body, platelets secrete substances called growth factors and other proteins that regulate cell division, stimulate tissue regeneration, and promote healing. Like stem cell therapy, PRP therapy is sometimes used alone with the hopes of healing an arthritic joint.

See PRP Injection Preparation and Composition

Physicians who use PRP and stem cells together think that the PRP can help maximize the healing effects of stem cells.7,8 Research in this area is ongoing.

See Platelet-Rich Plasma Injection Procedure

Stem cell therapy can vary depending on the doctor performing it. People considering stem cell therapy for an arthritic knee or other joint are advised to ask their doctors questions, including:

Both doctors and patients can benefit from having a frank conversation and setting reasonable expectations.

See Arthritis Treatment Specialists

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Is Stem Cell Therapy for Arthritis Safe and Effective?

The Power of Stem Cells | California’s Stem Cell Agency

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Stem cells have the potential to treat a wide range of diseases. Here, discover why these cells are such a powerful tool for treating diseaseand what hurdles experts face before new therapies reach patients.

How can stem cells treat disease?What diseases could be treated by stem cell research?How can I learn more about CIRM-funded research in a particular disease?What cell therapies are available right now?When will therapies based on embryonic stem cells become available?What about the therapies that are available overseas?Why does it take so long to create new therapies?How do scientists get stem cells to specialize into different cell types? How do scientists test stem cell therapies?Can’t stem cell therapies increase the chances of a tumor?Is there a risk of immune rejection with stem cells?How do scientists grow stem cells in the right conditions?

When most people think about about stem cells treating disease they think of a stem cell transplant.

In a stem cell transplant, embryonic stem cells are first specialized into the necessary adult cell type. Then, those mature cells replace tissue that is damaged by disease or injury. This type of treatment could be used to:

But embryonic stem cell-based therapies can do much more.

Any of these would have a significant impact on human health without transplanting a single cell.

In theory, theres no limit to the types of diseases that could be treated with stem cell research. Given that researchers may be able to study all cell types via embryonic stem cells, they have the potential to make breakthroughs in any disease.

CIRM has created disease pages for many of the major diseases being targeted by stem cell scientists. You can find those disease pages here.

You can also sort our complete list of CIRM awards to see what we’ve funded in different disease areas.

Many clinical trials for embryonic stem cell-based therapies have begun in recent years. Results from those won’t be available until the trials reveal that the therapies are safe and effectivewhich could take a few years.

While ten cell therapies have been approved around the world as of January 2016, the only widely used stem cell-based therapy is bone marrow transplantation. Blood-forming stem cells in the bone marrow were the first stem cells to be identified and were the first to be used in the clinic. This life-saving technique has helped thousands people worldwide who had been suffering from blood cancers, such as leukemia.

In addition to their current use in cancer treatments, research suggests that bone marrow transplants will be useful in treating autoimmune diseases and in helping people tolerate transplanted organs.

Other therapies based on adult stem cells are currently in clinical trials. Until those trials are complete we won’t know which type of stem cell is most effective in treating different diseases.

There is no way to predict when the first human embryonic stem cell therapies will become widely available. Several applications with the FDA to begin human trials of embryonic stem cell-based therapies have been approved. In general, the path from the first human trial to widespread use is on the order of a decade. That long time frame is a result of the many steps a therapy must go through in order to show that it is both safe and effective. Only once those steps are complete will the FDA approve the therapy for general use.

If embryonic stem cells follow a normal path it could still be many years before therapies based on embryonic stem cells are widely available. However, if researchers gave up on therapies simply because the path towards FDA approval is long, we would not have any of the lifesaving technologies that are now commonplace: recombinant insulin, bone marrow transplantation or chemotherapy drugs.

Find Out More:Read the top ten things to know about stem cell treatments (from ISSCR) Alan Lewis talks about getting an embryonic stem cell-based therapy to patients (3:46)

Many overseas clinics advertise miraculous stem cell therapies for a wide range of incurable diseases. This phenomenon is called stem cell tourism and is currently a source of concern for reputable stem cell scientists. International (and even domestic) clinics are offering up therapies that have not been tested for safety or even for effectiveness. In the past few years, some patients who visited those clinics have died as a result of receiving unproven, untested stem cells.

Find Out More:Learn more about the issue on our StemCell Tourism page. Jeanne Loring discusses concerns about stem cell tourism (3:38) CIRM/ISSCR panel on stem cell tourism

Embryonic stem cells hold the potential to treat a wide range of diseases. However, the path from the lab to the clinic is a long one. Before testing those cells in a human disease, researchers must grow the right cell type, find a way to test those cells, and make sure the cells are safe in animals before moving to human trials.

Find Out More:Hans Keirstead talks about hurdles in developing a new therapy (5:07)

One of the biggest hurdles in any embryonic stem cell-based therapy is coaxing stem cell to become a single the cell type. The vital process of maturing stem cells from a pluripotent state to an adult tissue type is called differentiation.

Guiding embryonic stem cells to become a particular cell type has been fraught with difficulty. Normally, stem cells growing in a developing embryo receive a carefully choreographed series of signals from the surrounding tissue. In a lab dish, researchers have to mimic those signals. Add the signals in the wrong order or the wrong dose and the developing cells may choose to remain immatureor become the wrong cell type

Many decades of research has uncovered many of the signals needed to properly differentiate cells. Other signals are still unknown. Many CIRM-funded researchers are attempting to differentiate very pure populations of mature cell types that can accelerate therapies.

Find Out More:Mark Mercola talks about differentiating cells into adult tissues (3:37)

Once a researcher has a mature cell type in a lab dish, the next step is to find out whether those cells can function in the body. For example, embryonic stem cells that have matured into insulin-producing cells in the lab are only useful if they continue producing insulin once transplanted inside a body. Likewise, researchers need to know that the cells can integrate into the surrounding tissue.

Scientists test cells by first developing an animal model that mimics the human disease, and then implanting the cells to see if they help treat the disease. These types of experiments can be painstakingbecause even if the cells dont completely cure the disease, they may restore some functions that would still be of enormous benefit to people. Researchers have to examine each of these possible outcomes.

In many cases testing the cells in a single animal model doesnt provide enough information. Most animal models of disease dont perfectly mimic the human disease. For example, a mouse carrying the same mutation that causes cystic fibrosis in humans doesnt show the same signs as a person with the disease. So, a stem cell therapy that treats this mouse model of cystic fibrosis may not work in humans. Thats why researchers often need to test the cells in more than oneanimal model.

The promise of embryonic stem cells is that they can form any type of cell in the body. The trouble is that when implanted into an animal they do just that, in the form of tumors called teratomas. These tumors consist of a mass of many cells types and can include hair cells and many other tissues.

These teratomas are one reason why it is necessary to mature the embryonic stem cells into highly purified adult cell types before implanting into humans. Virtually all evidence has shown that the mature cells are restricted to their one identity and dont appear to revert to a teratoma-forming cell.

Find Out More:UC Davis researcher focuses on stem cell safety (from UC Davis)Paul Knoepfler talks about the tendency of embryonic stem cells to form tumors (4:10)

Transplanted stem cells, like any transplanted organ, can be recognized by the immune system as foreign and then rejected. In organ transplants such as liver, kidney, or heart, people must be on immune suppressive drugs for the rest of their lives to prevent the immune system from recognizing that organ as foreign and destroying it.

The likelihood of the immune system rejecting a transplant of embryonic stem cell-based tissue depends on the origin of that tissue. Stem cells isolated from IVF embryos will have a genetic makeup that will not match that of the person who receives the transplant. That persons immune system will recognize those cells as foreign and reject the tissue unless a person is on powerful immune suppressive drugs.

Stem cells generated through SCNT or iPS cell technology, on the other hand, are a perfect genetic match. The immune system would likely overlook that transplanted cells, seeing it as a normal part of the body. Still, some suggest that even if the cells are perfectly matched, they may not entirely escape the notice of the immune system. Cancer cells, for example, have the same genetic make up as surrounding tissue and yet the immune system will often identify and destroy early tumors. Until more information is available from animal studies it will be hard to know whether transplanted patient-specific cells are likely to call the attention of the immune system.

Find Out More: Jeffrey Bluestone talks about immune rejection of stem cell-based therapies (4:05)

In order to be approved by the FDA for use in human trials, stem cells must be grown in good manufacturing practice (GMP) conditions. Under GMP standards, a cell line has to be manufactured so that each group of cells is grown in an identical, repeatable, sterile environment. This ensures that each batch of cells has the same properties, and each person getting a stem cell therapy gets an equivalent treatment. Although the FDA hasnt yet issued guidelines for how pluripotent stem cells need to meet GMP standards, achieving this level of consistency could mean knowing the exact identity and quantity of every component involved in growing the cells.

Updated 2/16

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The Power of Stem Cells | California’s Stem Cell Agency

Stem Cell Therapy | Advanced Regenerative Orthopedics

Stem Cell Therapy involves the use of stem cells to stimulate the bodys natural repair mechanisms to repair, regenerate or replace damaged cells, tissues and organs. This physician-directed therapy is very safe, ethical and does not entail the use of any fetal or embryonic cells or tissue. It has been described as the future of medicine by many prestigious groups including the National Institutes of Health and the Institute of Medicine.

The field of Stem Cell Therapy continues to evolve, focusing on cures rather than just treatments for essentially all types of chronic diseases and conditions, including diabetes and cardiovascular disease, as well as various forms of arthritis and various orthopedic problems. When cells are transplanted into a patient, they do not stay for more than a few days. However, the cells provide a large and robust stimulus to turn on native repair mechanisms. The number of stem cells present in the body and their functional capacity to repair damaged tissue declines with each advancing decade of life, and chronic diseases further impede their ability to respond to chronic injury or damage in the body. This is why research has led to new solutions, which include the use of umbilical cord blood as the source of cells, which have the most potent ability to generate new tissues without risk of rejection. We at Advanced Regenerative Orthopedics use stem cells that are supplied by an FDA-registered cord blood bank.

Stem Cell Therapy and Tissue Engineering are much simpler and effective options that use very powerful young cells to stimulate the patients own native repair mechanisms to regenerate new cartilage and bone. The physician-directed treatment at ARO is a comprehensive approach to a specific joint with the goal of reducing the disabling pain and increasing function.

At Advanced Regenerative Orthopedics, our goal is to provide minimally invasive treatments along with regenerative techniques to target your bodys natural healing ability. Used as part of our innovative, three-tiered approach, physician-directed arthritis stem cell treatment can help patients of all ages get pain relief, increase their joint mobility and enjoy a higher quality of life.

Stem cell therapy can be an effective treatment for those suffering from a broad range of arthritic conditions. By using stem cells for arthritis, Advanced Regenerative Orthopedics stimulates your bodys natural mechanism to repair, regenerate and replace damaged cells within your joints.

If you live in Tampa, Brandon, St. Petersburg, Clearwater, Lakeland, Sarasota, The Villages, Ocala, or the surrounding areas and are interested in learning more about using stem cells for arthritis or any other joint condition, please contact our courteous and efficient office staff today to schedule an appointment. We look forward to discussing the benefits of physician-directed arthritis stem cell treatment with you and determining the best course of treatment to restore your joint health.

As many of our patients travel to us from outside the state of Florida for our world class procedures, our team is very familiar with managing the care & travel for remote patients.

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Stem Cell Therapy | Advanced Regenerative Orthopedics

Stem Cell Therapy for Arthritis

Experts are researching ways to use stem cells to treat arthritis in the knee and other joints. Many doctors already use stem cell therapy to treat arthritis, but it is not considered standard practice.

Stem cell therapy is one of several non-surgical treatments for arthritis pain. See Knee Osteoarthritis Treatment

There is a lot of debate around stem cell treatment, and it is helpful for potential patients to understand what stem cells are and the issues surrounding their use in arthritis therapy.

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Stem cells are located throughout the body. What makes stem cells special is that they can:

See What Are Stem Cells?

Advocates of stem cell treatments hypothesize that, when placed into a certain environment, stem cells can transform to accommodate a certain need. For example, stem cells that are placed near damaged cartilage are hypothesized to develop into cartilage tissue.

See What Is Cartilage?

Stem cells can be applied during a surgery (such as the surgical repair of a torn knee meniscus) or delivered through injections directly into the arthritis joint.

Watch: Knee Meniscus Tear Video

When administering stem cell injections, many physicians use medical imaging, such as ultrasound, in order to deliver cells precisely to the site of cartilage damage.

The most common type of stem cells used for treating arthritis are mesenchymal stem cells. Mesenchymal stem cells are usually collected from the patients fat tissue, blood, or bone marrow.

The process of collecting cells is often called harvesting.

Bone marrow is usually taken from the pelvic bone using a needle and syringe, a process called bone marrow aspiration. The patient is given a local anesthetic and may also be given a sedative before the procedure.

There are no professional medical guidelines for who can and cannot receive stem cell therapy for arthritis. For now, the decision about who gets stem cell therapy is up to patients and doctors.

See Arthritis Treatment Specialists

There is some evidence that people with severe arthritis can benefit from stem cell therapy.1 Most research indicates that younger patients who have relatively mild osteoarthritis or cartilage damage see the most benefit.2

See What Is Osteoarthritis?

Some doctors have certain criteria for recommending stem cell therapy. For example, they only recommend it to patients who are healthy and have relatively little cartilage damage. Other doctors make recommendations on a case-by-case basis.

Stem cell therapy is a promising but still unproven treatment, and will not be covered by most insurance companies.

Complete Listing of References

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Stem Cell Therapy for Arthritis

Home – Stem Cell Therapy in Orlando, Florida

A Breakthrough Technology

Stem Cell Therapy is a procedure in which new cells are introduced directly into an injurious area or joint, promoting healing and growth. The multitude of administered cells allows the body to proceed with the healing process at an accelerated rate. This treatment has been recognized by the medical industry worldwide as the biggest medical breakthrough in natural healing. Athletes such as Kobe Bryant, Alex Rodriguez and Peyton Manning have traveled abroad for this unique treatment. And now, SCI brings this same solution to you right here in Florida.

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