By David Ikudayisi

Stem Cell Therapy comes in different types. Embryonic Stem Cell Therapy involves the use of embryonic stem cells derived from the inner cell mass of a blastocyst, an early-stage pre-implantation embryo at 4 days old to around 12 days old, leading to the destruction of the blastocyst which raises ethical and religious issues. Therefore, this type of Stem Cell Therapy is not the focus of this piece. The focus is Adult Stem Cells (ADSCs) and Induced Pluripotent Stem Cells (iPSCs). iPSCs are produced in the laboratories by reprogramming adult cells to express embryonic stem cells characteristics whereas ADSCs are cells obtained from an adult patient who will also be the recipient of the same stem cells.

In the United States, we must transplant the cells back to the same patient on the same day, while in some countries, the stem cells can be cultured to increase the quantity of stem cells before transplanting them back to the same patient who donated them.

Stem Cell Transplantation is a complex process that needs the care of experts in Regenerative Medicine, a new speciality of medicine . In order to ensure that science remains as the vehicle for hope and not harm, the controversies associated with the legal, social and legal issues of certain areas of stem cells research and stem cells potential clinical applications must be carefully examined. Advancing treatment and care for patients to save a life is and must be the ultimate goal.

Regenerative Medicine helps people to naturally regenerate and rejuvenate their bodies from the different conditions they may be suffering from without using chemicals or the orthodox medicine we are used to, but Adult Stem Cells Platelet Rich Plasma (PRP), that is, blood plasma that has been enriched with platelets, and contains growth factors which may elicit the gathering of stem cells around the damaged region stimulating cellular proliferation and tissue regeneration. PRP can be used to promote healing of injured tendons, ligaments, muscles, joints and can be applied to various musculoskeletal problems. The process allows your own (autologous) stem cells to be re-introduced into/around areas of damage or chronic disease. As mentioned earlier, the extraction and transplantation of the stem cells are done on the same day in the United States. Bone marrow transplant has been the most widely used Stem Cell Therapy till date, but Adult Adipose-Derived (fat) Stem Cell Therapy is fast gaining popularity as fat harvesting is less invasive than bone marrow harvesting. You get more stem cells from fat than bone marrow, and fat stem cells are not age-dependent. Adult Stem Cell Therapy may hold answers to many questions and problems that we doctors believed had no solutions, especially neurological disorders. The therapy, with or without PRP, revitalizes and regenerates the body organs and systems; it also reverses and repairs many pending subclinical medical problems before they become apparent, including the diseases that are age-related. Generally, Adult Stem Cell Therapy is safe as shown by many published research reports and clinical trials. However, this does not guarantee that adverse effects cant occur if the treatment is done by physicians that are not properly trained.

The therapy has helped a lot of people all over the world to regain their lives from debilitating ailments and Nigerians are not left behind. There are people in Nigeria that were either wheelchair bound and walking with occasional use of a cane before but now walking without one; diabetes patients are able to have restoration of vision in their eyes, and some feel and look younger. It has helped chronic kidney disease patients in Nigeria that are on hemodialysis to either reduce the frequency of hemodialysis per week or like a patient that was recommended to have kidney transplant a year ago but who is now off hemodialysis and off diabetic medications, and remains stable for the past months. Men with Erectile Dysfunction are now feeling like young men again. I cannot but mention that the type of treatment protocol and dosage of stem cells used also play a role in the efficacy of the treatment, and not everyone will respond in the same manner. Most of the patients, in studies, showed improvements after the first treatment, and the few that needed second treatment went on to see great results after more treatments were done; needless to say that they were elated with the results. The only group of patients that will always need more than a couple of transplantation sessions are patients with neurological disorders. Latest researches and evidence-based studies showed the number of treatment sessions needed to get significant clinical results can decrease by adding Exosomes to the treatment sessions.

In a recently publication in Germany, the new concept, developed around 2010 of how stem cells works, was reinforced where it stated that most of the effects of stem cells are through the Paracrine effects, delivered by the Exosomes. Exosomes are extracellular cell-derived vesicles that are present in almost all biological fluids. When secreted by stem cells, Exosomes are those tiny communication vesicles that interact with surrounding cells, thereby creating therapeutic activity. This is called the Paracrine effect. The Paracrine soluble factors (communication vesicles) have specialized functions and play a key role in intercellular signaling and in the following properties immune modulatory, neuroprotective, anti-inflammatory, neurotrophic, angiotrophic, anti-apoptotic and anti-oxidatory. Stem cells also secrete other important proteins and cytokines that have healing properties.

There are some diseases that conventional treatments have no cure for, but Adult Stem Cell Therapy can reverse the symptoms of those diseases, repair and regenerate the damaged tissues or organs affected. In some cases, it significantly slows down the progression of the disorder. For example, it can regenerate the bony joints in arthritis, repair and strengthen partial rotator cuff tears and avascular necrosis of the hip without surgery, revitalize the sexual organs in men and women, regenerate renal cells in kidney diseases, modulate immune system without use of medications that have very serious side effects in conditions like Rheumatoid Arthritis, Lupus, Scleroderma, Crohns disease, etc. Another advantage is its application in neurological disorders like ALS and spinal cord injury.

Adult Stem Cell Therapy can gradually lower diabetic medications dosage and eventually may get the patients off diabetic medications. This is evidenced by stem cells in a hyperglycemic medium differentiating into pancreatic cells; therefore leading to increased development of new blood vessels, secretion of various products of the immune system, and upregulation of pancreatic transcription factors and vascular growth factor. This aids the pancreas to regenerate and boost its ability to produce insulin. In stroke patients, stem cells activate cells around the suffering brain tissue to catalyze rapid healing and to improve brain function, thereby restoring motor function. Until recently, it was believed that damage to the brain tissue was permanent. This is being challenged by the evidences of re-growth of brain cells and improvements of neurological function documented with the use of Adult Stem Cells.

A procedure called P-Shot for Men uses the PRP Therapy to resolve challenges relating to Erectile Dysfunction by regenerating the damaged tissues. It gives treated men the possibility of saving their relationships by increasing stamina, enjoying bigger and harder genitals, and eventually increasing the length and girth. Orgasm-Shot for Women, the regenerative medicine procedure for womens sexual function, leads to increased ability to have orgasm, better arousal from clitoris stimulation, decreased pain during intercourse, tighter vaginal opening, increased sexual desire and natural lubrication, and increased arousal from G-spot stimulation. In addition, because of the O-Shot rejuvenation capabilities, there is help available for women suffering from urinary stress incontinence without the need for invasive surgery.

Since the stem cells used are autologous, there is no risk of rejection of the stem cell transplant. Nevertheless, as with any procedure, there is a risk of infection which can be very minimal or non-existent if done under the right conditions. Adult Stem Cells Transplantation can also be considered by people looking for alternative treatments especially in the areas of diabetes, hypertension, kidney disease, female and male sexual dysfunction, joint pain, neurological disorder and autoimmune disease. The cost of treatment varies, and it is not for everyone. However, you cant place a price tag on life just as the saying goes that health is wealth.

See more here:

Stem Cell Therapy: You can be sexually active again - Vanguard ... - Vanguard

Editor:

Re: (Stem cells to stem the wait? June 27):

There is a reason Health Canada has not approved certain stem-cell treatments: they have not been shown to work yet and even ones own minimally manipulated cells can be considered risky.

There is a great deal of research happening in Canada and globally and clinical trials are underway to test and improve the quality, safety and effectiveness of stem-cell therapies because scientists and industry believe they hold great promise.

As the KTW article noted, the federal government committed $20 million to the Centre for Commercialization of Regenerative Medicine in 2016, but it wasnt to establish a stem-cell therapy development facility in Toronto. Rather, the funding is to find better ways of manufacturing therapeutic cells, including stem cells, in the billions that are required for clinical use.

Not all stem cells are the same and it is crucial to ensure the purity of stem cells before they are injected into people.

There is a lot of support for stem-cell research and manufacturing in Canada and, if the public is patient, treatments will come.

For now, people seeking unapproved treatments should consider the risks (because they exist in the short-term and long-term) and be prepared to throw away their money if the treatment doesnt work.

Stacey Johnsondirector of communications and marketingCentre for Commercialization of Regenerative MedicineToronto

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Consider risks of unapproved stem cell treatment - Kamloops This ... - Kamloops This Week

After three and a half years, Johnson & Johnson is ducking out of a partnership with Capricor Therapeutics focusedon the use of stem cells to treat cardiovascular disease.

The decision by J&J's Janssen unit not to pursue a license comes as little surprise. The therapy at the center of their end-2013 dealCAP-1002 (off-the-shelf cardiosphere-derived cells)has already been marked up as missing the target in a phase 1/2 study involving patients who had suffered a heart attack, although the data remains under wraps.

Added to that, in April, interim results from a trial in Duchenne muscular dystrophy revealed promising activity, and prompted Capricor to upgrade the importance of the new indicationwhich lies outside the scope of its license with J&J.

The California biotech has already said it plans to start a second trial in DMD in the latter half of the year. But while the back-up indication is a comfort to investors, there is no question that the company will miss the financial backing from J&J, which included $12.5 million upfront and up to $325 million in milestone payments, as well as the kudos of a big pharma partner in a sector that has failed so far to live up to early promise.

Weak or scarred heart muscle is a major cause of heart failure, so using stem cells to repair scar tissue appears to be a logical way of improving outcomes. Attempts to show a benefit have met with marginal success, however. Last year for example, Celyad's 271-patient trial of its C-Cure stem cell therapy revealed no improvement compared to a sham procedure.

Capricor's CEO Linda Marbn, Ph.D. accentuated the positive of claiming full rights to CAP-1002, including not only the DMD data but also work with Janssen on developing a commercial-scale manufacturing process for the cell therapy, to which it now has a "fully paid-up nonexclusive license."

She also said it settled "uncertainty concerning the scope of the license for CAP-1002" and frees the company to seek partners elsewhere.

"We discussed potential product registration strategies for this indication at our recent meeting with the U.S. FDA, and we look forward to providing an update on our clinical development plans in DMD very shortly," continued Marbn.

Capricor also announced in an SEC filing that it is filingfor resale of up to 1.2 million shares of its common stock but would not be receiving any proceeds from the transaction. It ended the first quarter with $2.75 million in cash.

Shares in the biotech fell after the announcement but had rebounded at the time of writing, though they are still in penny stock territory at $0.80.

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Capricor yo-yos as J&J dumps stem cell partnership - FierceBiotech

Stem cells have saved thousands of lives thanks to their applications in cancer treatments. Many other uses peddled by private clinics are without evidence.

Stem cell science is an area of medical research that continues to offer great promise. But as this weeks paper in Science Translational Medicine highlights, a growing number of clinics around the globe, including in Australia, are exploiting regulatory gaps to sell so-called stem cell treatments without evidence that what they offer is effective or even safe.

Such unregulated direct-to-consumer advertising typically of cells obtained using liposuction-like methods not only places the health of individuals at risk, but could also undermine the legitimate development of stem cell-based therapies.

Many academic societies and professional medical organisations have raised concerns about these futile and often expensive cell therapies. Despite this, national regulators have typically been slow or ineffective in curtailing them.

As well as tighter regulations here, international regulators such as the World Health Organisation and the International Council on Harmonisation need to move on ensuring patients desperate for cures arent sold treatments with limited efficacy and unknown safety.

Hundreds of stem cell clinics post online claims that they have been able to treat patients suffering from a wide range of conditions. These include osteoarthritis, pain, spinal cord injury, multiple sclerosis, diabetes and infertility. The websites are high on rhetoric of science often using various accreditation, awards and other tokens to imply legitimacy but low on proof that they work.

Rather than producing independently verified results, these clinics rely on patient testimonials or unsubstantiated claims of improvement. In so doing these shonky clinics understate the risks to patient health associated with these unproven stem cell-based interventions.

Properly administered informed consent is often overlooked or ignored, so patients can be misled about the likelihood of success. In addition to heavy financial burdens imposed on patients and their families, there is often an opportunity cost because the time wasted in receiving futile stem cells diverts patients away from proven medicines.

The many recent reports of adverse outcomes demonstrate the risks of receiving unproven cell therapies are not trivial. In the USA three women were blinded following experimental stem cell treatment for macular degeneration (a degenerative eye disease that can cause blindness). One man was rendered a quadriplegic following a stem cell intervention for stroke. And a woman whose family sought treatment for her dementia died in Australia.

Other notorious cases involving the deaths of patients include the German government shutting down the X-Cell Centre and the Italian government closing the Stamina Foundation it had previously supported.

At present, the only recognised stem cell treatments are those utilising blood stem cells isolated from bone marrow, peripheral blood (the cellular components of blood such as red and white blood cells and platelets) or umbilical cord blood.

Hundreds of thousand of lives have been saved over the last half-century in patients with cancers such as leukaemia, lymphoma and multiple myeloma, as well as rare inherited immune and metabolic disorders.

A few types of cancer and autoimmune diseases may also benefit from blood stem cells in the context of chemotherapy. Different stem cells are also successfully used for corneal and skin grafting.

All other applications remain in the preclinical research phase or are just starting to be evaluated in clinical trials.

Further reading: Yes theres hope, but treating spinal injuries with stem cells is not a reality yet

Often dismissed by for-profit clinics as red tape hampering progress, the rigour of clinical trials allows for the collection of impartial evidence. Such information is usually required before a new drug or medical device is released into the marketplace. Unfortunately, in the case of for-profit stem cell clinics, their marketing has gazumped the scientific evidence.

Action is required on many fronts. Regulators at both an international and national level need to tackle regulatory loopholes and challenge unfounded marketing claims of businesses selling unproven stem cell interventions.

Researchers need to more clearly communicate their findings and the necessary next steps to responsibly take their science from the laboratory to the clinic. And they should acknowledge that this will take time.

Patients and their loved ones must be encouraged to seek advice from a trained reputable health care professional, someone who knows their medical history. They should think twice if someone is offering a treatment outside standards of practice.

The stakes are too high not to have these difficult conversations. If a stem cell treatment sounds too good to be true, it probably is.

For more information on recognised stem cell treatments visit the National Stem Cell Foundation of Australia and Stem Cells Australia, Choice Australia, EuroStemCell, International Society for Stem Cell Research, and International Society for Cellular Therapy.

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Private clinics' peddling of unproven stem cell treatments is unsafe and unethical - The Conversation AU

Stem cells have long been used to treat blood cancers and some immune diseases. But some doctors are offering stem cell treatments for diseases still under clinical trial. Photograph: Mauricio Lima/AFP/Getty Images

Medical and legal experts from around the world have united to call for more stringent regulation of stem cell therapies to prevent people pursuing unproven and potentially deadly treatments overseas.

In a perspective piece for the US journal Science Translational Medicine, 15 experts from countries including the UK, the US, Canada, Belgium, Italy and Japan wrote that national efforts alone would not be enough to counter an industry offering unproven treatments to vulnerable patients.

Stem cell-based interventions are classified under diverse and potentially incompatible national regulatory frameworks, the authors wrote.

Approaches for international regulation not only need to develop consistent rules over the commercialisation of medical practices and products but also need to give them teeth by developing cross-border partnerships for compliance.

Stem cells found in bone marrow and umbilical cord blood have long been used to successfully treat blood cancers including leukaemia and some immune diseases. But those are among the few proven treatments. Legitimate and ethics-approved clinical trials by academic centres are also occurring, exploring the potential of stem cells to treat a wider range of diseases.

But some doctors are directly offering to the general public stem cell treatments for diseases still under clinical trial or for which no evidence exists and for which the safety and efficacy is as yet unproven.

Deaths as a result of stem cell treatments have already occurred. In 2013 Sheila Drysdale died in a New South Wales nursing home after undergoing an unproven liposuction stem-cell therapy at a western Sydney clinic. Following Drysldales death, her doctor, Ralph Bright, gave a statement to police in which he claimed that stem-cell treatment could improve comorbidities and that stem cells could move from joints to other parts of the body to improve disease in distant sites including lungs and brain, vision, mentation and pain.

In his report into Drysdales death, the coroner Hugh Dillon wrote that he could not say what motivated Dr Bright to perform this unproven, dubious procedure on Sheila Drysdale.

But regardless of his motivation, Dr Brights performance as a medical practitioner was, for the reasons outlined above, poor and resulted in Sheila Drysdales death.

The Medical Council of NSW investigated Bright and placed a number of restrictions on his right to practice. Bright is still authorised to practise stem cell therapy for patients with osteoarthritis or who are taking part in research studies approved by an ethics committee. He is also still allowed to treat patients returning for remaining injections of stored cells.

In 2013 a Queensland woman, Kellie van Meurs, died when she travelled to Russia to undergo stem-cell treatment for a rare neurological disorder. She died of a heart attack as a result.

Australias drug regulator, the Therapeutic Goods Administration, last year sought feedback on the regulation of autologous stem-cell therapies but is yet to publish those submissions. A TGA spokeswoman said the Administration was still examining the options for changes to the legislation to reflect public and industry views. The TGA currently considers autologous treatments, which involve treating someone with their own tissue or cells, to be a therapeutic good and, therefore, does not regulate them. Stem cells used for medical practice and therapeutic purposes are covered by different regulatory frameworks.

Associate Professor Megan Munsie, a University of Melbourne stem cell scientist and a co-author of the paper, said: The idea that stem cells are magical holds court in the community, along with this idea the advances in treatment are being held up by red tape.

Unethical health practitioners exploited this, she said, along with the vulnerability of patients with difficult-to-treat or incurable conditions.

There is a precedent for international regulation of this industry because regulations already exist around drugs the way they are manufactured, she said.

This could be extended to the regulation to the stem cell and tissue-based therapies. This international stance would then force or encourage stronger local regulations.

There have been successful efforts by scientists to push back against unscrupulous doctors. In Italy scientists and regulators highlighted the unproven yet government-subsidised treatments being offered by the entrepreneur Davide Vannoni and fought to stop him. He was convicted of criminal charges but the sentence was later suspended.

See the rest here:

Stem cell therapies: medical experts call for strict international rules - The Guardian

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Read more:

Stem cell therapies breaking barriers - Guardian (blog)

July 6, 2017 Material design empowered by protein sequence space. Credit: Department of Chemical and Biological Engineering, HKUST

Hydrogels, noted for their biomimetic properties, are the leading materials for biomedical applications, such as drug delivery and stem cell therapy. Traditional hydrogels made up of either synthetic polymers or natural biomolecules often serve as passive scaffolds for molecular or cellular species, which render these materials unable to fully recapitulate the dynamic signaling involved in biological processes, such as cell/tissue development.

Photo-responsive hydrogels are of particular interest to material scientists, because light is regarded as an ideal tool to control molecules or cell behavior with high spatiotemporal precision and little invasiveness. The major challenge for scientist is how to assemble these complex globular proteins into supramolecular architectures efficiently while preserving their function.

In a recent research, a group of scientists from The Hong Kong University of Science and Technology created a B12-dependent light-sensing hydrogel by covalently stitching together the photoreceptor C-terminal adenosylcobalamin binding domain (CarHC) proteins under mild conditions. This direct assembly of stimuli-responsive proteins into hydrogels represents a versatile solution for designing "smart" materials and opens up enormous opportunities for future material biology.

The findings were published in the journal PNAS on June 6, 2017.

"In our research, we were able to create an entirely recombinant protein-based light-sensitive hydrogels by covalently assembling the CarHC photoreceptor proteins using genetically encoded SpyTag-SpyCatcher chemistry," said Fei Sun, author of the paper and assistant professor at HKUST's department of chemical and biomolecular engineering. "The AdoB12-dependent CarHC tetramerization has been shown to be essential for the formation of an elastic hydrogel in the dark, which can undergo a rapid gel-sol transition caused by light-induced CarHC disassembly."

"The resulting hydrogel composed of physically self-assembled CarHC polymers exhibited a rapid gel-sol transition on light exposure, which enabled the facile release/recovery of 3T3 fibroblasts and human mesenchymal stem cells (hMSCs) from 3D cultures while maintaining their viability." Sun added. "Given the growing demand for creating stimuli-responsive "smart" hydrogels, the direct assembly of stimuli-responsive proteins into hydrogels represents a versatile strategy for designing dynamically tunable materials."

Explore further: Investigating folding stability and dynamics of proteins

More information: Ri Wang et al, B12-dependent photoresponsive protein hydrogels for controlled stem cell/protein release, Proceedings of the National Academy of Sciences (2017). DOI: 10.1073/pnas.1621350114

Journal reference: Proceedings of the National Academy of Sciences

Provided by: Hong Kong University of Science and Technology

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(Phys.org)The synthesis of carboxylic acid derivatives from unsaturated carbon compounds is important for making chemicals used in pharmaceuticals, cosmetics, polymers, and agrochemicals. In industry this reaction is done ...

Researchers at The University of Manchester in collaboration with Central South University (CSU), China, have created a new kind of ceramic coating that could revolutionise hypersonic travel for air, space and defense purposes.

Marijuana is now legal for recreational or medicinal use in at least 28 states and the District of Columbia. But driving under the influence of marijuana is illegal no matter which state you're in. To enforce the law, authorities ...

Biofuels like the ethanol in U.S. gasoline could get cheaper thanks to experts at Rutgers University-New Brunswick and Michigan State University.

Trihydrogen, or H3+, has been called the molecule that made the universe, where it plays a greater role in astrochemistry than any other molecule. While H3+ is astronomically abundant, no scientist understood the mechanisms ...

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Photo-responsive protein hydrogels as agent for controlled stem cell/protein release - Phys.Org

Stem cells are the building blocks of lifeessential to every organism. They self-renew and replicate, with the ability to form anytype of tissue in the body. Adult stem cells are undifferentiated cells, meaning that cells from one part of the bodycan transform their function to that ofother types of tissue, a quality known as plasticity. Plasticityis the key function of stem cells in regenerative medicine.

The Lung Institute offers stem cell treatment for many major pulmonary conditions, including chronic obstructive pulmonary disease(COPD), emphysema, chronic bronchitis, pulmonary fibrosisand interstitial lung disease. The Lung Institute usesautologous stem cells, cells derivedfrom the patients own body. These versatilecells are extractedfrom one of the following tissues:

Adult stem cells canform many types of differentiated cells, so when theyare returned to the patient, they can promote the healing of lung tissuepotentially leadingto improved lung function.

The stemcellsare harvested from the patients own blood or bone marrow. The stem cells are separated and returned to the patient intravenously. Once the cells are returned to the patient, they can begin to promote healing.

When something, such as medication, blood, or stem cells, is introduced to your body through an IV, it goes directly to the right side of the heart. Within a heartbeat or two, it is pushed straight to the lungs. Then your blood distributes the item throughout the body. However, this processchanges a little when it comes to stem cells. During studies conducted for the National Institutes of Health (NIH), researchers found that stem cells go through this process but get trapped when they arrive in the lungs. This is commonlycalled the pulmonary trap, and although itmay not be good news for someone who wishes to see those cells move throughout the body, its a happy occurrence forthose looking to slow down the progression ofa chronic lung disease.

If you would like to find out more about treatment optionsand to see if you qualify, contact our patient coordinators today at (800) 729-3065to schedule afree consultation.

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Lung Institute | Stem Cell Treatment Basics

Zhongju Shi,1,2 Hongyun Huang,3 Shiqing Feng1,2

1Department of Orthopaedics, Tianjin Medical University General Hospital, 2Institute of Neurology, Key Laboratory of Post-Neuroinjury Neuro-Repair and Regeneration in Central Nervous System, Ministry of Education, Tianjin City, Tianjin, 3Institute of Neurorestoratology, General Hospital of Armed Police Forces, Beijing, Peoples Republic of China

Abstract: Spinal cord injury (SCI) is a devastating condition and major burden on society and individuals. Currently, neurorestorative strategies, including stem cell therapy products or mature/functionally differentiated cell-derived cell therapy products, can restore patients with chronic complete SCI to some degree of neurological functions. The stem cells for neurorestoration include neural stem cells, mesenchymal stem cells, embryonic stem cells, induced pluripotent stem cells, etc. A better understanding of the merits, demerits and precise function of different stem cells in the treatment of SCI may aid in the development of neurorestorative strategies. However, the efficacy, safety and ethical concerns of stem cell-based therapy continue to be challenged. Nonetheless, stem cell-based therapies hold promise of widespread applications, particularly in areas of SCI, and have the potential to be novel therapeutics, which contributes to the repair of SCI. This review mainly focused on recent advances regarding the stem cell-based therapies in the treatment of SCI and discussed future perspectives in this field.

Keywords: spinal cord injury, neural stem cells, bone marrow-derived mesenchymal stem cells, adipose-derived stem cells, embryonic stem cells, induced pluripotent stem cells

This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

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Stem cell-based therapies to treat spinal cord injury: a review - Dove Medical Press

The arthritis in Maureen Munsies ankles was so intense until barely a year ago, she literally had to crawl on hands and knees to get upstairs.

The pain, she recalls now, took my breath away, and played havoc with the avid hikers favourite pastime.

In desperation, Munsie turned to a Toronto-area clinic that provides a treatment many experts consider still experimental, unproven and of questionable safety.

The 63-year-old says the stem cells she received at Regenervate Medical Injection Therapy 18 months ago were transformational, all but eliminating the debilitating soreness and even allowing her to hike Argentinas Patagonia mountains two months ago.

For me its been a life saver, Munsie says. Ive been able to do it all again I dont have any of that pain, at all.

Canadians drawn to the healing promise of stem cells have for years travelled outside the country to such places as Mexico, China or Arizona, taking part in a dubious form of medical tourism.

But Regenervate is one of a handful of clinics in Canada that have begun offering injections of stem cells, satisfying growing demand but raising questions about whether a medical idea with huge potential is ready for routine patient care.

Especially when those patients can pay thousands of dollars for the service.

Clinics in Ontario and Alberta are treating arthritis, joint injuries, disc problems and even skin conditions with stem cells typically taken from patients fat tissue or bone marrow.

The underlying idea is compelling: stem cells can differentiate or transform into many other types of cell, a unique quality that evidence suggests allows them to grow or regenerate tissue damaged by disease or injury.

Researchers including hundreds in Canada alone are examining stem-cell treatments for everything from ailing hearts to severed spinal cords.

With few exceptions, however, the concept is still being studied in the lab or in human trials; virtually none of the treatments have been definitively proven effective by science or approved by regulators like Health Canada.

The fact that Canadian clinics are now offering stem-cell treatments commercially is concerning on a number of levels, not least because of safety issues, says Ubaka Ogbogu, a health law professor at the University of Alberta.

Three U.S. women were blinded after receiving stem-cell injections in their eyes, while other American patients have developed bony masses or tumours at injection sites, Ogbogu said.

Stem cells have to be controlled to act exactly the way you want them to act, and thats why the research takes time, he said. It is simply wrong for these clinics to take a proof of concept and run with it.

Ogbogu says Health Canada must crack down on the burgeoning industry but says the regulator has so far been conspicuous by its inaction.

Other experts say the procedures provided here typically for joint pain are likely relatively safe, but still warn that care must be taken that the stem cells do not develop into the wrong type of tissue, or at the wrong place.

Alberta Health Services convened a workshop on the issue late last year, concluding there is an urgent need to develop a certification system for cell preparation and delivery to avoid spontaneous transformation of (stem cells) into unwanted tissue.

But one of the pioneers of the service in Canada says theres no empirical evidence that such growths can develop, and suggests the treatments only real risk as with an invasive procedure is infection.

Meanwhile, patients at Regenervate have enjoyed impressive outcomes after paying fees from $750 to $3,900, says Dr. Douglas Stoddard, the clinics medical director.

About 80 per cent report less pain, stiffness and weakness within a few months of getting their stem-cell injection, he said.

I believe medical progress is not just limited to the laboratory and randomized double-blind trials, Stoddard said. A lot of progress starts in the clinic, dealing with patients You see something works, you see something has merit, and then its usually the scientists that seem to catch up later.

The Orthopedic Sport Institute in Collingwood, Ont., the Central Alberta Pain and Rehabilitation Institute and Cleveland Clinic in Toronto all advertise similar stem-cell treatments for orthopedic problems.

Edmontons Regen Clinic says it plans to start doing so this fall.

Ottawas Innovo says it also treats a range of back conditions with injections between the vertebrae, and uses stem cells to alleviate nerve damage.

Orthopedic Sport says its doctor focuses on FDA and Health Canada approved stem-cell injection therapy for patient care.

In fact, no treatment of the sort the clinics here provide has ever been authorized.

Health Canada says the vast majority of stem-cell therapies would constitute a drug and therefore need to be authorized after a clinical trial or new drug submission.

A number of stem-cell trials are underway, but only one treatment Prochymal has been approved, said department spokesman Eric Morrissette. Designed to combat graft-versus-host disease where bone marrow transplants for treating cancer essentially attack the patients body its unlike any of the services the stem-cell providers here offer.

But as the U.S. Food and Drug Administration aggressively pursues the hundreds of clinics in America, Health Canada says only that its committed to addressing complaints it receives.

It will take action based on the risk posed to the general public, said Morrissette, who encouraged people to pass on to the department information about possible non-compliant products.

Stoddard said the injections his clinics provide are made up of minimally manipulated tissue from patients own bodies and any attempt to crack down would be regulation for the sake of regulation.

But academic experts remain skeptical about the effectiveness of the treatments.

Scientific evidence suggests the injections may help alleviate joint pain temporarily, but probably just because of anti-inflammatory secretions from the cells not regeneration, said Dr. David Hart, an orthopedic surgery professor at the University of Calgary who headed the Alberta workshop.

Theres a need for understanding whats going on here and theres a need for regulation, he said.

Most of the clinics say they use a centrifuge to concentrate the stem cells after removing them from patients fat tissue or bone marrow. But its unclear if the clinics even know how many cells they are eventually injecting into patients, says Jeff Biernaskie, a stem-cell scientist at the University of Calgary.

Munsie, on the other hand, has no doubts about the value of her own treatment, even with a $3,000 price tag.

The procedure from extraction of fat tissue in her behind to the injection of cells into her ankles took barely over an hour.

Within three months, the retired massage therapist from north of Toronto says she could walk her dogs again. Last week, she was hiking near Banff.

Im a real believer in it, and the possibility of stem cells, says Munsie. I just think Wow, if we can heal with our own body, its pretty amazing.

tblackwell@nationalpost.com

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Canadian clinics begin offering stem-cell treatments experts call unproven, possibly unsafe - National Post

Bareilly: Dog owners from across the country, including Delhi and Gujarat, are turning up with their paralytic pets at the Indian Veterinary Research Institute (IVRI) here for stem cell therapy. Scientists treat a paralyzed dog by transplanting stem cells from healthy dogs. IVRI is the second institute in the country to offer this treatment, after Madras Veterinary College, Chennai.

According to scientists, no research has been conducted to determine the number of dogs who suffer from paralysis every year in India. However, the institute receives at least four cases every week of spinal trauma which causes paralysis in dogs. IVRI recorded 143 cases of posterior paralysis in 2016. These were treated with stem cell therapy and medicines.

If dogs are treated only with medicines, recovery is witnessed only in a few cases, said Amarpal (who goes by his first name), head and principal scientist, division of surgery, IVRI. On an average, 17% recovery rate was noted among dogs administered only medicines.

However, the best response was recorded among severely affected dogs when they were treated using stem cells, where almost all the patients responded to treatment to variable extent, said the scientist. Though we have cases where recovery was 100%, the average recovery rate is about 50%. The experiment proved the efficacy of stem cell therapy in cases of paralysis due to spinal trauma, said Amarpal.

The paralytic dog is first administered anesthesia before the stem cells are injected into its spinal cord. It takes only one session for a dog to undergo the therapy and it is discharged the same day.. After this, the owner has to bring his pet for check-ups for two or more times so that vets can monitor how the animal is responding to the treatment and if it is suffering from any reaction, said Amarpal.

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Stem cell therapy to treat paralytic dogs draws pet owners from ... - Times of India

Dr. Ren Halverson can emphasize with his patients. Like many of those who walk through his doors at Advanced Chiropractic in Brunswick, he has also experienced injuries and the pain they cause.

I had a torn labrum in my right shoulder, a torn rotator cuff in my left shoulder and and torn meniscus in my right knee. I already had two surgeries on my knees, he said. It was a daily challenge treating patients.

In order to help his patients and himself find relief, the chiropractor is always on the lookout for the latest in scientific health developments that might help. He spends countless hours studying the latest in medical innovations. Not too long ago, Halversons research paid off when he came across amniotic stem cells.

Of course, Halverson was already familiar with stem cells and the long term research concerning some for joint treatment. But the new data, methods and results were something he simply couldnt ignore.

World-wide the results with stem cells are off the charts. There are different types of stem cells ... blood marrow, which is best used for blood diseases. Amniotic, which is the membrane surrounding the placenta and is the safeguard between the mothers blood flow and the babys. That is what we are talking about here, he said. It has proven to be best for joint and tendon repair.

Amniotic arent, however, the same as the controversial fetal stem cells that gained so much attention over the past decade. Halverson says these types of stem cells raise no moral or ethical questions. They are also more effective than other types of stem cells in healing musklo-skeletal injuries.

These are offered by willing, cesarean donors. The FDA has approved the process and it is very strictly regulated. The hosts, the mothers who donate, are screened for all blood born pathogens before they are able to donate.

The regenerative field of medicine is something that has proven itself invaluable over the past few decades. It has convinced Halverson to open that door to his patients. After all, he has experienced the positive effects of the treatment first hand.

I wanted to try the stem cell treatment first. I did it about three months ago and the results are just incredible, he said, moving his arms to illustrate his range of motion.

It takes about eight months for the full effects to set in but Im swimming again. I couldnt do that before. In many cases worldwide, patients have been able to fully heal arthritic joints and tendons or cartilage tears without having to have surgery.

He feels the statistics truly speak for themselves. The company Halverson uses has conducted more than 100,000 similar treatments.

Stem cells contain Hyaluronic Acid which provides a scaffold for mesenchymal growth cells to begin the rebuilding process. They also contain natural anti inflammatory agents known as Cytokines.

Halverson says there is not one documented case of a side effect reported.

There has never been a negative reaction. Patient satisfaction is/over 98 percent ... thats just in the U.S. They are doing this heavily in Europe and Israel, he said. The results are unbelievable. Pre- and post -X-rays show remarkable results.

He will however bring on new faces who will run the expanded medical clinic.

Our medical director is Dr. Theresa Cezar, who is a great internist but has extensive experience in physical medicine. We also have Cynthia White who is our nurse practitioner. They are both excellent, he said. We have a really exceptional staff here.

In addition to the stem cell treatments, Halverson is offering an expanded line of medical services, designed to treat musklo-skeletal patients with a cutting edge integrated approach. Those include trigger point injections, state of the art spinal bracing, biomechanics as well as the regeneration therapy, which includes stem cell and Hormone Replacement Therapy.

Halverson is excited about the opportunity to bring these innovative techniques to the Golden Isles. He sees these treatments as a significant building blocks in the future of healthcare, a departure from relying on medication, dangerous opioids and other invasive options.

Ive experienced it and I know it works. Even Medicare says integration with medicine, chiropractic and therapies together are the wave of the future. We are combining what weve already been doing ... the chiropractic and rehabilitation to really take this to the next level, Halverson said.

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Doctors to offer stem cell treatments - The News (subscription)

Reader Charles Wang wrote in to ask if stem cell therapy is approved for use in Singapore. Stem cell therapy refers to the use of stem cells to treat various medical conditions. Mr Wang also asked if it is available, and where one can seek this treatment.

Health reporter Linette Lai answered.

Any new treatment must be backed by sufficient scientific evidence to ensure that it is safe and effective. However, there is not enough scientific evidence yet for stem cell therapy to be approved as a mainstream treatment in Singapore.

There is not enough scientific evidence yet to ensure that stem cell therapy is safe and effective for it to be approved as a mainstream treatment in Singapore. PHOTO: ST FILE

A Health Ministry spokesman said: "To date, stem cell therapy has not been substantiated by sufficient clinical evidence as a form of mainstream treatment for any diseases or ailments and is not available as a treatment in our public hospitals.

"If any registered medical practitioners or institutions want to administer stem cells as a form of medical treatment, it will have to be conducted within the context of clinical trials."

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askST: Is stem cell therapy available in Singapore?, Health News ... - The Straits Times

Reader Charles Wang wrote to ask if stem cell therapy - the use of stem cells to treat various medical conditions - is approved in Singapore. Mr Wang also asked where one could seek this treatment if it is available. Health reporter Linette Lai answered.

Any new treatment must be backed up by sufficient scientific evidence to ensure that it is safe and effective. However, there is still not enough scientific evidence available for stem cell therapy to be approved as a mainstream treatment in Singapore.

A Ministry of Health spokesman said: "To date, stem cell therapy has not been substantiated by sufficient clinical evidence as a form of mainstream treatment for any diseases or ailments, and it is not available as a treatment in our public hospitals.

"If any registered medical practitioners or institutions want to administer stem cells as a form of medical treatment, it would have to be conducted within the context of clinical trials."

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Is stem cell therapy approved in Singapore? - The Straits Times

LUCY Clarke was facing a downhill spiral when she flew to Russia to undergo a cutting edge stem cell transplant.

Two years on she says the procedure not only halted her illness in its tracks, but reversed much of the damage inflicted by multiple sclerosis.

The 41-year-old from Inverness is now backing crowdfunding efforts so that her friend and neighbour, Rona Tynan, can receive the same life-changing operation in Mexico before she becomes too ill to qualify.

Mrs Tynan, 50, has until the end of August to raise the 60,000 needed.

However, both are angry at a cross-border divide which means that a small number of MS patients in England can undergo the treatment for free on the NHS, while in Scotland despite having some of the highest rates of MS in the world the health service has refused patients' funding and no clinical trials are planned.

Mrs Clarke, a chemistry graduate and acupuncturist, began investigating AHSCT (autologous haematopoietic stem cell transplantation) in 2014 after her condition progressed from relapsing-remitting to secondary progressive MS. At the time her son was three and she feared ending up in a wheelchair.

Although the treatment has been available overseas for decades, it has never been routinely available on the NHS and is considered unproven by many neurologists.

It is also a highly aggressive therapy, using intensive chemotherapy to strip out sufferers faulty immune systems before replenishing it with stem cells harvested from their own bone marrow or donor tissue. Despite the risks, many patients including Mrs Clarke credit it with transforming their lives.

She underwent the procedure in Moscow over a period of four weeks in April and May 2015. She said: From when my son was three to when I had the transplant, my walking had deteriorated, I needed to use a walking stick all the time, I had very poor balance, debilitating fatigue, I had brain fog, I used to slur my words.

"Im left-handed and my left hand was really weak so my writing was bad. Other things would come and go numbness in my legs, tingling, cramps in my calves, sore and painful legs. The majority of them have gone since the transplant.

I noticed quite quick improvements in things like balance. The biggest thing is not really having fatigue, and the brain fog completely went. I stopped slurring my words quite quickly after treatment. I was more alert. I had more concentration, more focus. Within six months the shaking in my left arm had gone. Ive still got drop foot in my right leg and I still use a walking stick, but once youve got to the stage of secondary progressive it all gets a bit scary. Things are going downhill and youre told theres nothing that can be done, so really my goal from treatment was just to halt the progression to know I wasnt getting any worse. Thankfully, and luckily, I have seen lots of benefits.

Eighteen months on, MRI brain scans show no signs of disease progression and while Mrs Clarke stresses that the treatment is neither a magic bullet nor a walk in the park, she is supporting Rona Tynans bid to undergo the same surgery in October.

Mrs Tynan, a retired Metropolitan police sergeant and mother-of-two from Inverness, also has secondary progressive MS. She is already in a wheelchair and fears that unless she undergoes the treatment soon she will become too ill. She said: Im a 7.5 out of 10 on the disease progression scale, where 10 is death. Most clinics stop taking you at seven, but Mexico just raised it to 8.5. Thats brilliant for people like myself, but I cant afford to get any more ill.

So far, Mrs Tynans fundraising page on JustGiving has raised nearly 4000, but she is frustrated that more is not being done to help Scottish patients. In England, clinical trials are ongoing in London and Sheffield but a small number of patients with relapsing-remitting MS can be referred for the treatment off-trial, for free, on the NHS. In Scotland, however, eligible patients have been turned down for NHS funding.

Mrs Tynan said: It seems crazy to me that Brits are going to Chicago and Mexico and Russia for a treatment that in the long-run could save the NHS loads of money. Scotland is one of the worst places in the world for MS yet in England you can get this treatment for free. Why arent we fighting in Scotland to get this?

Mrs Clarke added: Its very unfair. It just seems a no brainer to me why they wouldnt make it available not for all patients but for some. The Scottish Government said referral decisions were "for clinicians".

A spokesman said: "Whilst the vast majority of healthcare provided by NHS Scotland is delivered in Scotland, NHS boards can commission treatment in other countries on an ad hoc basis, particularly where highly specialised treatment is involved. Decisions to refer patients are for clinicians, based on agreed guidelines, which ensure best practice, equity of access and consistency of treatment for all patients.

"HSCT is not currently widely available anywhere on the NHS, but people from Scotland can participate in trials held in other centres across the UK, where clinically determined appropriate and beneficial."

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Anger as Scots patients miss out on 'breakthrough' stem cell therapy offered by NHS England - Herald Scotland

The government of Texas will allow clinics across the state to market unapproved stem-cell therapies, in a move that has met with criticism from bioethicists.

Last week Governor Greg Abbott signed off on the new legislation that allows clinics to by-pass FDA approval for investigational stem cell treatments for patients with certain severe chronic diseases or terminal illnesses. Like right to try laws in other States, the Texas legislation will give desperate patients access to therapies that provide hope after traditional medical treatments have failed.

Currently, most patients wishing to have stem-cell therapy have to travel out of the country to receive it. The new law will allow people with severe chronic or terminal illness to be treated at a clinic that purports to isolate therapeutic stem cells from adult tissuesuch as a patients own fatif their doctor recommends it after considering all other options, and if its administered by a physician at a hospital or medical school with oversight from an institutional review board (IRB). It also requires that the same intervention already be tested on humans in a clinical trial.

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The law sanctions a much broader set of therapies than federal rules, which already exempt certain stem cell interventions from FDAs lengthy approval process, provided the cells are only minimally manipulated and perform the same function they normally have in the body.

Bioethicists have expressed their concern at the move, which they say puts patients at risk of the effects of dangerous, untested therapies.

University of Minnesota bioethicist Leigh Turner said he was sceptical about whether the clinics would be adequately monitored, while NYU Langone Medical Center bioethicist Beth Roxland said it was insufficient to have the therapies tested in clinical trials while by-passing FDA approval. You could gain access to something [as long as its] being studied in a human somewhere on the planet, Roxland told Science, which in the stem cell area makes it really very scary.

LifeNews Note: This appeared at Bioedge.org and is reprinted with permission.

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Texas gives green-light for experimental stem-cell therapies - LifeNews.com

Treatment

The Stem Cell treatment performed at our clinics is a painless medical procedure where Stem Cells (cellular building blocks) are usually administered intravenously and subcutaneously (under the skin). The whole procedure takes approximately one hour and has no known negative side effects.

Following the treatment, the Fetal Stem Cells will travel throughout the body, detecting damaged cells and tissue and attempts to restore them. The Fetal Stem Cells can also stimulate existing normal cells and tissues to operate at a higher level of function, boosting the bodys own repair mechanisms to aid in the healing process. These highly adaptive cells then remain in the body, continually locating and repairing any damage they encounter.

As with any medical treatment, safety should be of the highest priority. The Stem Cells used in our treatment undergo extensive screening for possible infection and impurities.

Utilizing tests more sophisticated than those regularly used in the United States for Stem Cell research and transplant. Our testing process ensures we use only the healthiest cells to enable the safest and most effective Fetal Stem Cell treatment possible. And, unlike other types of Stem Cells, there is no danger of the bodys rejection of Fetal Stem Cells due to the fact they are immune privileged. This means that you can give the cells to any patient without matching, use of immunosuppressive drugs and without rejection. This unique quality eliminates the need for drugs used to suppress the immune system, which can leave a patient exposed to serious infections.

With over 3000 patients treated, Stem Cell Of America has achieved positive results with a wide variety of illnesses, conditions and injuries. Often, in cases where the diseases continued to worsen, our patients have reported substantial improvements following the Stem Cell treatment.

Patients have experienced favorable developments such as reduction or elimination of pain, increased strength and mobility, improved cognitive function, higher tolerance for chemotherapy, and quicker healing and recovery.

To view follow up letters from patients, please visit the patient experiences page on our website.

All statements, opinions, and advice on this page is provided for educational information only. It is not a substitute for proper medical diagnosis and care. Like all medical treatments and procedures, results may significantly vary and positive results may not always be achieved. Please contact us so we may evaluate your specific case.

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Breakthrough Stem Cell Treatments, Stem Cell Therapy, & Stem ...

The government of Texas will allow clinics across the state to market unapproved stem-cell therapies, in a move that has met with criticism from bioethicists.

Last week Governor Greg Abbott signed off on the new legislation that allows clinics to by-pass FDA approval for investigational stem cell treatments for patients with certain severe chronic diseases or terminal illnesses. Like right to try laws in other States, the Texas legislation will give desperate patients access to therapies that provide hope after traditional medical treatments have failed.

Currently, most patients wishing to have stem-cell therapy have to travel out of the country to receive it. The new law will allow people with severe chronic or terminal illness to be treated at a clinic that purports to isolate therapeutic stem cells from adult tissuesuch as a patients own fatif their doctor recommends it after considering all other options, and if its administered by a physician at a hospital or medical school with oversight from an institutional review board (IRB). It also requires that the same intervention already be tested on humans in a clinical trial.

The law sanctions a much broader set of therapies than federal rules, which already exempt certain stem cell interventions from FDAs lengthy approval process, provided the cells are only minimally manipulated and perform the same function they normally have in the body.

Bioethicists have expressed their concern at the move, which they say puts patients at risk of the effects of dangerous, untested therapies.

University of Minnesota bioethicist Leigh Turner said he was sceptical about whether the clinics would be adequately monitored, while NYU Langone Medical Center bioethicist Beth Roxland said it was insufficient to have the therapies tested in clinical trials while by-passing FDA approval. You could gain access to something [as long as its] being studied in a human somewhere on the planet, Roxland told Science, which in the stem cell area makes it really very scary.

MORE ON THESE TOPICS |

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Texas gives green-light for experimental stem-cell therapies - BioEdge

Representational picture

Raising hopes of new and less painful treatment for burn injuries, a 26-year-old patient with Grade 2 burn injuries was successfully treated using stem cell therapy at a city-based hospital, doctors said on Thursday.

Anand Tiwari suffered burns after accidentally falling in a boiler unit while at work. He sustained Grade 2 and early Grade 3 burns in all parts of the body below his neck.

When admitted to the city based StemRx Bioscience Solutions hospital, he had severe burning sensation and pain all over the body. Blisters and swellings were noticed in many areas of his chest and limbs.

According to doctors, after initial care and stabilisation of the patient, for treatment of burns, a treatment protocol was prepared by Pradeep Mahajan, a regenerative medicine researcher at Stemrx Bioscience Solutions Hospital.

Explaining the treatment procedure, Mahajan said: "This involved the use of growth factors and fibroblasts and collagen based gel. These biological agents stimulate natural healing mechanisms in the body."

"The advantage of these growth factors is that they can be obtained from the patients' own body and hence are safe and effective. Additionally, unlike conventional treatment options, biological agents promote faster recovery," he said.

Under the stem cell therapy, the treatment process has to be repeated continuously so as to get rid of the problem completely and accordingly the procedure was performed.

"During the entire treatment, the patient was not given any closed dressing. He also underwent blood and supplementary fluid transfusion as required to maintain systemic homeostasis," said Mahajan.

He said that changes in the patient were observed as early as two-three days after the initiation of therapy. Drying of superficial burns began and swelling started reducing.

"Gradually, dry crusts started peeling and by the end of the third week, initial healing of most areas was complete. There was no odour or oozing from any wound and he did not complain of pain or burning sensation anymore.

"After a month-long treatment, healthy skin formation is being observed and further healing is progressing at an impressive rate," said Mahajan, adding that in treatment through conventional modalities, it takes more than eight weeks for healing to happen and further several months for patient to be able to regain joint and facial movements.

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Patient with severe burns treated using stem cell therapy in Mumbai - Mid-Day

Takeda says it is assessing manufacturing options ahead of potential European approval later this year of the Crohns disease stem cell therapy licensed from TiGenix.

Following its acceptance for review by the European Medicines Agency (EMA), Takeda and TiGenix announced this week Swissmedic has accepted for review the file for compound Cx601, an allogeneic expanded adipose-derived stem cell (eASC) therapy for the treatment of complex perianal fistulas in patients with Crohns disease.

The therapy is being made from TiGenix site in Madrid, Spain but CEO Eduardo Bravo told Biopharma-Reporter its partner Takeda which holds the rights for Cx601 in non-US markets following a licensing agreement inked last year will take responsibility for its manufacture from 2021 from a purpose built manufacturing facility in Europe.

Takeda spokesman Luke Willats told this publication: After a transition period for technology transfer during which TiGenix will manufacture Cx601, Takeda will assume responsibility for manufacturing the compound.

But while Willats added the firm is exploring how itcan best meet manufacturing responsibilities for Cx601 following a potential European Commission (EC) approval decision for the compound in 2017, he could not comment further on specific plans or CAPEX investments.

The Japanese pharma firm has its European headquarters in Switzerland, with production sites in Austria, Belgium, Denmark, Estonia, Germany, Ireland, Italy, Norway, Poland and Russia.

Fat chance

Cx601 is produced by TiGenix in plastic flasks in incubators at a one-litre scale, using stem cells taken from healthy volunteers who have undergone liposuction for cosmetic reasons, Bravo told us.

The fat gets sent to our facility in Madrid and is processed to extract the stem cells, which account for about 2% of the material. These are placed in plastic flasks with serum to multiply the number. This is repeated until there is a large population and then the cells are frozen, creating the master cell bank (MCB).

According to Bravo, one liposuction when expanded produces upwards of 360 billion cells, enough to treat 2,400 patients.

While TiGenix is considering using bioreactors for its future pipeline, it will continue making the product as it does now due to not needing to increase volume and the challenges of making production changes in the middle or end of development.

For cell therapies, the process defines the product. Anything you change could change the cells themselves, effectively changing the product.

US deal with Lonza

TiGenix holds the US rights to Cx601 and is discussing with the US Food and Drug Administration (FDA) whether it can file using EMA data, something Bravo said would be decided in the next six-to-eight months.

US trial material will be produced by TiGenixs contract manufacturing organisation (CMO) Lonza , which is undergoing tech transfer at its site in Maryland.

But looking ahead to commercialisation, Bravo said it is not yet decided whether we continue using a CMO or build our own [US] facility.

See more here:

Takeda prepping to take over EU production of stem cell therapy from 2021 - BioPharma-Reporter.com