I regularly see comments on various social media sites from MS patients who have traveled, or who plan to travel, outside the U.S. to be treated with stem cells. Some of these patients have reported excellent results and a reversal of symptoms. Others have died. Many MS patients are frustrated with the slow stem-cell approval process in the U.S.

I wrote about this slow process in February, but just the other day someone commented on that old column, and said she was heading to Russia soon for a stem cell transplant:

They started studying it in Chicago more than 20 years ago, it is ridiculous that is still has not been approved! Boy, they keep on approving those high priced drugs that dont work and can kill you! I have been studying this and waiting for 17 years for approval in the states. I cant wait any longer, I am heading to Moscow in February to receive the treatment that I need!

But an article that recently appeared in the journal Science Translational Medicine strongly warns against this sort of thing, and what the authors call the marketing of unproven stem cell-based interventions.

Those authors are 15 scientists from seven countries. One of them is Sarah Chan of the University of Edinburgh. Quoted in a university press release, her remarks sound as if they could be directed to the MS patient who is heading to Moscow:

Many patients feel that potential cures are being held back by red tape and lengthy approval processes. Although this can be frustrating, these procedures are there to protect patients from undergoing needless treatments that could put their lives at risk.

The scientists concerns are about stem cell therapies for many diseases, not just those that are used as MS treatments. The authors call the practice of advertising therapies that arent supported by clinical research, and that are often made directly to patients, stem cell tourism.

Chan and her colleagues are calling for the World Health Organization to offer guidance on what should be considered responsible clinical use of cells and tissues, just as the WHO does for medicines and medical devices.

Stem cell therapies hold a lot of promise, Chan writes, but we need rigorous clinical trials and regulatory processes to determine whether a proposed treatment is safe, effective and better than existing treatments.

Rather than rushing through stem cell approval in the U.S., the authors call for tighter regulations on stem cell therapy advertising, especially regarding potential clinical benefits. They also think that international regulatory standards should be established for the manufacture and testing of human cell and tissue-based therapies.

Thats all well and good, but where does that leave the MS patients who need this treatment now, not five or 10 years from now? What do they say to the woman whos been waiting for 17 years and can wait no longer, so shes headed to Russia? How many more months or years of clinical trials are needed before stem cell therapies will be considered safe, effective and better than existing treatments in the United States?

Just askin.

(Youre invited to follow my personal blog at http://www.themswire.com)

***

Note:Multiple Sclerosis News Todayis strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those ofMultiple Sclerosis News Today, or its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to multiple sclerosis.

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A Warning About 'Stem Cell Tourism' - Multiple Sclerosis News Today

Springs Integrated Health offers leading-edge, all-natural medical care. The center provides services intended to get to the root of patient issues and deliver real, lasting results in the simplest, most effective way. Instead of covering up symptoms with medications, the clinic breaks down health into obtainable goals that can optimize the wellness of each and every patient. Services include chiropractic, hormone lab testing, physical rehabilitation, Supartz therapy, trigger point therapy, FAR infrared sauna, stem cell therapy and more.

There was a time when stem cell therapy was out of reach for most people, but it has become increasingly accessible in recent years; and a go-to solution for a range of physiological complications. Stem cells are blank cells in the body that can become any tissue, whether that be knee tissue, bone tissue, cartilage, organ tissue stem cells can become whatever they are closest and nearest to, said Tiffany Graham, DC of Springs Integrated Health. So when you inject them into a joint thats damaged the body is always healing itself anyway it can create new tissue where there has been damage.

Stem cell therapy has been used for decades in Europe, and in the United States has been used by Peyton Manning, Tiger Woods, and many NFL players and other professional athletes. Although stem cells were initially reserved for the ultra wealthy, they have since become both affordable and accessible; and many patients are opting for them over lengthy and expensive knee and shoulder surgeries. One in 400 total knee replacements result in fatal infection, and those that do not end up in infection still prove to have an extensive recovery time. Stem cell therapy is safe and quick, and people can feel results in as little as one week. Further, the company Springs Integrated Health utilizes for stem cells has given more than 50,000 injections with zero side effects and zero adverse reactions.

There are two different types of stem cells. The first is adult stem cells, where patients take their own bone marrow, fat or blood; spin it down; and re-inject into the joints. Thats not what is used at Springs Integrated Health, because its a long procedure that can be very painful and expensive. The second is amniotic stem cells, which are from donated placental tissue. This tissue comes from mothers who have planned c-sections, and who have elected to donate their placenta to science. The stem cells have been thoroughly tested and are clear of all antigens, so there is no risk for rejection or infection. The stem cells used at Springs Integrated Health are 100 percent ethically-sourced, and are not embryonic stem cells, which come from aborted fetal tissue, said Graham.

Rick Paine is a beaming example of the efficacy of stem cell therapy. He is an avid runner and hiker, and coached swimming at the University of Nebraska for 17 years. He was also an Olympic Head Coach in Australia in 2000. Eight years ago, he wore his left knee out and had to get a knee replacement, and it took two to three years to recover. About two years ago, his right knee was becoming worn out, and he did not want to go through the another knee surgery, because it was a very unpleasant experience for him. He was seeing an active release therapist who was helping, but he still had trouble with downhill on hikes, walking on the golf course and doing the everyday activities that make him happy.

Paine had been seeing Dr. Graham for about a year and a half before deciding to commence with stem cell therapy for his torn medial meniscus on the right knee in November 2016. At first I was skeptical, but I thought, lets give it a shot, Paine said. The procedure was quick and pretty painless, and it only took about a month after the injection for my knee to feel really good. He cautions that although the knee may feel great in a month or less, its essential to still take it easy, and give the tissue time to grow before becoming physically active.

Before I got stem cells, I couldnt squat to pick up a ball on the golf course but since getting the stem cells I can definitely do that. Im 65 years old, and a surgery would have taken me out of hiking for two to three years, but with this, it was only three months until I was hiking again, said Paine. We took X-rays a few months ago, and there has been significant improvement in my knee. I didnt expect to see that, I thought it was too good to be true, but Im living proof that stem cell therapy works.

Paine shared that now, eight months after his procedure, his knee still feels perfect. He admits that its not like having a brand new knee, but he has no issues whatsoever with downhill, uphill or bending down. I knew I wanted to do at least one more 14er, and didnt think it would be possible, but stem cells have definitely allowed me to do that. Paine is now gearing up for a 12 mile hike from Crested Butte to Aspen, a hike he couldnt have even considered before stem cells. I wish we had stem cells way back when, because it would have saved a lot of athletes careers.

To receive a complimentary consultation, or to attend an upcoming, free informational seminar at Springs Integrated Health, call 719-301-6649 or visit SpringsIntegratedHealth.com.

Springs Integrated Health is located at 1712 W. Uintah St., Colorado Springs. Hours are Monday, 10 a.m. to 12:30 p.m. and 3 to 6 p.m.; Tuesday, 3 to 6 p.m.; Wednesday, 10 a.m. to 12:30 p.m. and 3 to 6 p.m.; Thursday, 3 to 6 p.m.; and Friday 8 to 10 a.m.

Here is the original post:

Stem Cell Therapy can provide a surgery-free solution to knee and shoulder issues - Colorado Springs Gazette

Stem cell therapy isnt approved to treat heart failure in the US, but dozens of clinics nationwide advertise the treatments anyway, often charging thousands of dollars for procedures that may not be safe or effective, a new study suggests.

Researchers found 61 centers offering stem cell therapies for heart failure as of last year in the US alone, including five that claimed to have performed more than 100 procedures. Only nine centers required copies of patients medical records and just one facility said it had a board certified cardiologist on staff.

We simply do not know anything about the quality of the treatment delivered at these centers, said senior study author Dr. Paul Hauptman director of heart failure at Saint Louis University Hospital.

These centers are not regulated in any way, Hauptman said by email.

Almost 6 million Americans have heart failure, and its one of the most common reasons older adults go to the hospital, according to the American Heart Association.

It happens when the heart muscle is too weak to effectively pump enough blood through the body. Symptoms can include fatigue, weight gain from fluid retention, shortness of breath and coughing or wheezing. Medications can help strengthen the heart and minimize fluid buildup in the body.

While some experimental stem cell therapies for heart failure are currently being tested in late-stage human trials, none have won approval from the US Food and Drug Administration.

In theory, after a transplant, stem cells could permanently become part of the diseased heart and either help grow new healthy heart tissue or tell existing cells to work better, said Paul Knoepfler, a cell biology researcher at the University of California Davis School of Medicine in Sacramento who wasnt involved in the study.

Its also possible stem cells could temporarily visit the heart and stimulate a positive response in cells already there, he said.

Even though theres no conclusive proof yet that any stem cell treatments are safe and effective for heart failure, centers contacted for the study charge an average of $7,694 for each treatment using patients own stem cells and $6,038 for each procedure with donor stem cells.

In one instance, though, a clinic staff member said, If you have a million dollars to spend we will set you up with weekly infusions.

Hauptmans team had used a standard script when contacting each center, asking about the stem cell treatment itself, medical exams before and afterward and pricing.

Among the other responses they received from clinic staff were remarks such as, If you know anyone that can start an IV, a neighbor that is a nurse for example, we can send you the stem cells and that person can administer them to you and We hope you dont believe your doctor when they tell you there is nothing they can do, you were smart to call us.

None of the sites in the study discussed what methods they used to isolate or identify stem cells, though most claimed to use patients cells and 24 said they got cells from fat tissue.

Most centers claimed to deliver cells intravenously, researchers report in JAMA Internal Medicine.

This approach has been associated with complications such as stroke, in which infused cells block blood vessels in the brain, said Douglas Sipp, a researcher at RIKEN Center for Developmental Biology in Kobe, Japan, who wasnt involved in the study.

The biggest risk is that patients will waste their money, time and hopes on an unnecessary and useless invasive procedure, Sipp said by email.

If any stem cell treatment did ultimately prove safe and effective enough to win FDA approval, it would likely offer a significant improvement over the limited treatment options currently available, said Leigh Turner, a researcher at the University of Minnesota Center for Bioethics who wasnt involved in the study.

But its impossible to say what patients would get at unregulated clinics offering unapproved stem cell therapies, Turner said by email. In at least two cases unrelated to the current study, patients died after getting stem cell procedures at a clinic in Florida, and in another case at a different Florida clinic, a woman went blind, Turner noted.

Clinics marketing stem cell treatments to patients suffering from heart failure might be administering anything from slurries of mixed cells, some of which might be stem cells, to nothing more than cellular debris, Turner said. Often one can only speculate.

See the article here:

More than 60 US clinics have sold unproven stem cell therapies for heart failure - New York Post

However, when looking at this great promise in terms of return on investment, let us be completely honest, most early stage stem cell investors have lost their shirts. We are now more than twenty years removed from the earliest commercial stem cell companies that were founded in the late 1980's, went public in the late 1990's and who were once seen as an exciting investment opportunity, but ended up being a huge disappointment.

So, should investors still be interested in regenerative medicine? After all, stem cells have largely produced failures and unregulated stem cell clinics marketing unproven therapies are taking over. The answer is a resounding yes, but the dot-com like era of regenerative medicine, which led investors to pour money into anything and anyone marketing a cell therapy is over. Investors will need to look at companies solving issues with stem cells or those taking a completely new approach.

One company that is looking to address many of the issues with stem cell therapies, as well as developing another approach to regenerative medicine is Endonovo Therapeutics, Inc. (OTCQB: ENDV). On the stem cell front, ENDV is using its Time Varying Electromagnetic Fields (TVEMF) technology, originally developed at the National Aeronautics and Space Administration (NASA) to expand and activate stem cells to produce more biologically potent cell therapies. However, more importantly, ENDV is developing a non-invasive medical device that would render many of the cell therapies currently under development obsolete. These devices, called Electroceuticals, harness the electrical signals that our cells and nerves use to control the immune and regenerative response to treat inflammatory and degenerative diseases. ENDV is developing this exciting technology for treating and preventing heart failure following a heart attack, to treat chronic kidney disease, peripheral artery disease and non-alcoholic steatohepatitis (NASH).

Another small biotech company like ENDV working on electric treatments for diseases is Pulse Biosciences (NASDAQ: PLSE), whose Nano-Pulse Stimulation (NPS) technology uses nano second electric pulses to illicit an immune response for the treatment of cancer. PLSE recently announced the treatment of its first patient in a study to evaluate the safety and efficacy of its novel NPS technology for seborrheic keratosis (SK) lesions. SK is one of the most common types of skin lesions, affecting more than 80 million patients in the United States. Additionally, PLSE announced that it will host its quarterly investor conference call on July 27, 2017, at 1:30 p.m. PDT / 4:30 p.m. EDT. The company will provide an update on the clinical advancement of the PulseTx[TM] System, including progress of the clinical study evaluating NPS for the treatment of seborrheic keratosis (SK), as well as the status of the 510(k) submission from earlier this year.

Another company seeking to address past pitfalls of stem cell therapies is Pluristem Therapeutics, Inc. (NASDAQ: PSTI) is a developer of placenta-based cell therapy product candidates for the treatment of multiple ischemic, inflammatory and hematologic conditions. Pluristem's products include PLX-PAD and PLX R18. The Company's PLX cells are adherent stromal cells (ASCs) that are expanded using a three dimensional (3D) process. The system utilizes a synthetic scaffold to create an artificial 3D environment where placental-derived stromal cells can grow. This process allows the cells to be expanded rapidly while remaining healthy and potent cells that can secrete therapeutic biomolecules. The Company's PLX products are administered using a standard needle and syringe. PSTI recently announced that Austria's regulatory health agency, the Austrian Agency for Health and Food Safety (AGES), had cleared Pluristem to begin enrollment in Austria for its pivotal Phase III trial of PLX-PAD cells to treat critical limb ischemia.

In other stem cell news:

Cytori Therapeutics, Inc. (NASDAQ: CYTX) recently announced that its STAR study assessing its Habeo Cell Therapy for the treatment of Scleroderma had failed to meet its primary endpoint at week 24 nor any of its secondary endpoints at week 24 or week 48. On the other hand, CYTX stated that there were 'clinically meaningful' improvements in both the primary and secondary endpoints of both hand function and scleroderma-associated functional disability compared to placebo in a subgroup of patients with diffuse cutaneous scleroderma, a more severe form of the disease. The company has stated that it will continue it analysis of the data before determining its next steps.

Capricor Therapeutics, Inc. (NASDAQ: CAPR) a biotechnology company developing biological therapies for Duchenne muscular dystrophy and other rare diseases, following news that Janssen Biotech, Inc. had decided not to exercise its option to exclusively license Capricor's lead candidate CAP-1002 for the development and commercialization in the field of cardiology, announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to CAP-1002, Capricor's development candidate for the treatment of Duchenne muscular dystrophy, a debilitating genetic disorder characterized by progressive weakness and chronic inflammation of skeletal, heart, and respiratory muscles. The Rare Pediatric Disease Designation, as well as the Orphan Drug Designation previously granted to CAP-1002 by the FDA, covers the broad treatment of DMD. Upon receiving market approval for CAP-1002 by the FDA, Capricor would be eligible to receive a Priority Review Voucher.

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The Big Deal About Stem Cell Therapies and Regenerative Medicine - PR Newswire (press release)

A stem cell-based method created by University of California, Irvine scientists can selectively target and kill cancerous tissue while preventing some of the toxic side effects of chemotherapy by treating the disease in a more localized way.

Weian Zhao, associate professor of pharmaceutical sciences, and colleagues have programmed human bone marrow stem cells to identify the unique physical properties of cancerous tissue. They added a piece of code to their engineered cells so that they can detect distinctively stiff cancerous tissue, lock into it and activate therapeutics.

In a study appearing inScience Translational Medicine, the researchers report they have effectively and safely employed this stem cell-targeting system in mice to treat metastatic breast cancer that had spread to the lung. They first transplanted the engineered stem cells to let them find and settle into the tumor site where they secreted enzymes called cytosine deaminase. The mice were then administered an inactive chemotherapy called prodrug 5-flurocytosine, which was triggered into action by the tumor site enzymes.

Zhao said his team specifically focused on metastatic cancer, which comes when the disease spreads to other parts of the body. Metastatic tumors are particularly deadly and the cause of 90 percent of cancer deaths.

This is a new paradigm for cancer therapy, Zhao said. We are going in a direction that few have explored before, and we hope to offer an alternative and potentially more effective cancer treatment.

Zhao added that this stem cell-targeting approach can provide an alternative to many forms of chemotherapy, which has a number of bad side effects. While this widely used method is powerful enough to kill rapidly growing cancer cells, it also can harm healthy ones.

Our new type of treatment only targets metastatic tissue, which enables us to avoid some of conventional chemotherapys unwanted side effects, said Zhao, who is a member of the Chao Family Comprehensive Cancer Center and the Sue & Bill Gross Stem Cell Research Center at UCI.

This published work is focused on breast cancer metastases in the lungs, he added. However, the technology will be applicable to other metastases as well, because many solid tumors have the hallmark of being stiffer than normal tissue. This is why our system is innovative and powerful, as we dont have to spend the time to identify and develop a new genetic or protein marker for every kind of cancer.

So far, the Zhao team has done preclinical animal studies to demonstrate that the treatment works and is safe, and they hope to transition to human studies in the near future. They are currently expanding to include other type of cells, including cancer tissue-sensing, engineered immune-system T cells (called CAR-T) to treat metastasizing breast and colon cancers. They also plan to transform the technology for other diseases such as fibrosis and diabetes, which result in stiffening of otherwise healthy tissue.

Along with Zhao, UCI doctoral students Linan Liu and Shirley Zhang, are co-leading authors of the study. The National Institutes of Health, the Department of Defense, the American Cancer Society and the California Institute for Regenerative Medicine provided support.

Read more here:

Stem Cell Therapy Attacks Cancer by Targeting Unique Tissue ... - R & D Magazine

Stem cells in the brain could be the key to extending life and slowing ageing. These cells which are located in the hypothalamus, a region that produces hormones and other signalling molecules can reinvigorate declining brain function and muscle strength in middle-aged mice, according to a study published on July 26in Nature1.

Previous studies have suggested that the hypothalamus is involved in ageing, but the latest research shows that stem cells in this region can slow the process. That makes sense, because the hypothalamus is involved in many bodily functions, including inflammation and appetite, says Dongsheng Cai, a neuroendocrinologist at Albert Einstein College of Medicine in New York City.

In their study, Cai and his colleagues found that stem cells in the hypothalamus disappear as mice grow older. When the researchers injected their mice with viruses that destroy these cells, the animals seemed to grow older faster, experiencing declines in memory, muscle strength, endurance and coordination. They also died sooner than untreated mice of the same age.

Next, the team injected stem cells taken from the hypothalami of newborn mice into the brains of middle-aged mice. After four months, these animals had better cognitive and muscular function than untreated mice of the same age. They also lived about 10% longer, on average.

The researchers found that these stem cells release molecules called microRNAs, which help to regulate gene expression, into the cerebrospinal fluid. When the team injected these microRNAs into the brains of middle-aged mice, they found that the molecules slowed cognitive decline and muscle degeneration.

It's an interesting paper, says Leonard Guarente, a molecular biologist at the Massachusetts Institute of Technology in Cambridge, who studies ageing. He adds that it could lead to various ways of developing anti-ageing therapies in people.

Stem-cell therapies might enhance the ability of the hypothalamus to act as a master regulator, given that the latest results suggest it controls ageing through signalling peptides such as hormones and microRNAs, Cai says. He says that his team is trying to identify which of the thousands of types of microRNA produced are involved in ageing, and hopes to investigate whether similar mechanisms exist in non-human primates.

The findings represent a breakthrough in ageing research, says Shin-ichiro Imai, who studies ageing at Washington University in St Louis, Missouri. The next steps would be to link these stem cells with other physiological mechanisms of ageing, he says. For instance, these cells may have a role in regulating the neurons that release a hormone called GnRH, which is secreted by the hypothalamus and is associated with ageing. Imai would also like to know whether the microRNAs from the cells can pass into the bloodstream, which would carry them throughout the body.

Cai suspects that anti-ageing therapies targeting the hypothalamus would need to be administered in middle age, before a persons muscles and metabolism have degenerated beyond a point that could be reversed.

It is unclear by how much such a therapy could extend a human lifespan, but Guarente says that slowing the effects of ageing is the more important goal. Living longer isnt important if youre not healthy, he says.

This article is reproduced with permission and wasfirst publishedon July 26, 2017.

See the original post:

Brain's Stem Cells Slow Ageing in Mice - Scientific American

Stem cell therapy isn't approved to treat heart failure in the U.S., but dozens of clinics nationwide advertise the treatments anyway, often charging thousands of dollars for procedures that may not be safe or effective, a new study suggests.

Researchers found 61 centers offering stem cell therapies for heart failure as of last year in the U.S. alone, including five that claimed to have performed more than 100 procedures. Only nine centers required copies of patients' medical records and just one facility said it had a board certified cardiologist on staff.

NEUROLOGIST BACKS FAMILY'S FIGHT TO OVERTURN TEEN'S DEATH CERTIFICATE

"We simply do not know anything about the quality of the treatment delivered at these centers," said senior study author Dr. Paul Hauptman director of heart failure at Saint Louis University Hospital.

"These centers are not regulated in any way," Hauptman said by email.

Almost 6 million Americans have heart failure, and it's one of the most common reasons older adults go to the hospital, according to the American Heart Association.

It happens when the heart muscle is too weak to effectively pump enough blood through the body. Symptoms can include fatigue, weight gain from fluid retention, shortness of breath and coughing or wheezing. Medications can help strengthen the heart and minimize fluid buildup in the body.

While some experimental stem cell therapies for heart failure are currently being tested in late-stage human trials, none have won approval from the U.S. Food and Drug Administration.

CTE FOUND IN BRAINS OF 110 OUT OF 111 DECEASED NFLERS

In theory, after a transplant, stem cells could permanently become part of the diseased heart and either help grow new healthy heart tissue or tell existing cells to work better, said Paul Knoepfler, a cell biology researcher at the University of California Davis School of Medicine in Sacramento who wasn't involved in the study.

It's also possible stem cells could temporarily visit the heart and stimulate a positive response in cells already there, he said.

Even though there's no conclusive proof yet that any stem cell treatments are safe and effective for heart failure, centers contacted for the study charge an average of $7,694 for each treatment using patient's own stem cells and $6,038 for each procedure with donor stem cells.

In one instance, though, a clinic staff member said, "If you have a million dollars to spend we will set you up with weekly infusions."

Hauptman's team had used a standard script when contacting each center, asking about the stem cell treatment itself, medical exams before and afterward and pricing.

Among the other responses they received from clinic staff were remarks such as, "If you know anyone that can start an IV, a neighbor that is a nurse for example, we can send you the stem cells and that person can administer them to you" and "We hope you don't believe your doctor when they tell you there is nothing they can do, you were smart to call us."

None of the sites in the study discussed what methods they used to isolate or identify stem cells, though most claimed to use patients' cells and 24 said they got cells from fat tissue.

Most centers claimed to deliver cells intravenously, researchers report in JAMA Internal Medicine.

"This approach has been associated with complications such as stroke, in which infused cells block blood vessels in the brain," said Douglas Sipp, a researcher at RIKEN Center for Developmental Biology in Kobe, Japan, who wasn't involved in the study.

"The biggest risk is that patients will waste their money, time and hopes on an unnecessary and useless invasive procedure," Sipp said by email.

DENTIST FACES CHARGES AFTER 4-YEAR-OLD SUFFERS BRAIN DAMAGE

If any stem cell treatment did ultimately prove safe and effective enough to win FDA approval, it would likely offer a significant improvement over the limited treatment options currently available, said Leigh Turner, a researcher at the University of Minnesota Center for Bioethics who wasn't involved in the study.

But it's impossible to say what patients would get at unregulated clinics offering unapproved stem cell therapies, Turner said by email. In at least two cases unrelated to the current study, patients died after getting stem cell procedures at a clinic in Florida, and in another case at a different Florida clinic, a woman went blind, Turner noted.

"Clinics marketing stem cell treatments to patients suffering from heart failure might be administering anything from slurries of mixed cells, some of which might be stem cells, to nothing more than cellular debris," Turner said. "Often one can only speculate."

The rest is here:

Dozens of US clinics sell unproven stem cell therapies for heart failure - Fox News

Stem cell therapy isnt approved to treat heart failure in the U.S., but dozens of clinics nationwide advertise the treatments anyway, often charging thousands of dollars for procedures that may not be safe or effective, a new study suggests.

Researchers found 61 centers offering stem cell therapies for heart failure as of last year in the U.S. alone, including five that claimed to have performed more than 100 procedures. Only nine centers required copies of patients medical records and just one facility said it had a board certified cardiologist on staff.

We simply do not know anything about the quality of the treatment delivered at these centers, said senior study author Dr. Paul Hauptman director of heart failure at Saint Louis University Hospital.

These centers are not regulated in any way, Hauptman said by email.

Almost 6 million Americans have heart failure, and its one of the most common reasons older adults go to the hospital, according to the American Heart Association.

It happens when the heart muscle is too weak to effectively pump enough blood through the body. Symptoms can include fatigue, weight gain from fluid retention, shortness of breath and coughing or wheezing. Medications can help strengthen the heart and minimize fluid buildup in the body.

While some experimental stem cell therapies for heart failure are currently being tested in late-stage human trials, none have won approval from the U.S. Food and Drug Administration.

In theory, after a transplant, stem cells could permanently become part of the diseased heart and either help grow new healthy heart tissue or tell existing cells to work better, said Paul Knoepfler, a cell biology researcher at the University of California Davis School of Medicine in Sacramento who wasnt involved in the study.

Its also possible stem cells could temporarily visit the heart and stimulate a positive response in cells already there, he said.

Even though theres no conclusive proof yet that any stem cell treatments are safe and effective for heart failure, centers contacted for the study charge an average of $7,694 for each treatment using patients own stem cells and $6,038 for each procedure with donor stem cells.

In one instance, though, a clinic staff member said, If you have a million dollars to spend we will set you up with weekly infusions.

Hauptmans team had used a standard script when contacting each center, asking about the stem cell treatment itself, medical exams before and afterward and pricing.

Among the other responses they received from clinic staff were remarks such as, If you know anyone that can start an IV, a neighbor that is a nurse for example, we can send you the stem cells and that person can administer them to you and We hope you don't believe your doctor when they tell you there is nothing they can do, you were smart to call us.

None of the sites in the study discussed what methods they used to isolate or identify stem cells, though most claimed to use patients cells and 24 said they got cells from fat tissue.

Most centers claimed to deliver cells intravenously, researchers report in JAMA Internal Medicine.

This approach has been associated with complications such as stroke, in which infused cells block blood vessels in the brain, said Douglas Sipp, a researcher at RIKEN Center for Developmental Biology in Kobe, Japan, who wasnt involved in the study.

The biggest risk is that patients will waste their money, time and hopes on an unnecessary and useless invasive procedure, Sipp said by email.

If any stem cell treatment did ultimately prove safe and effective enough to win FDA approval, it would likely offer a significant improvement over the limited treatment options currently available, said Leigh Turner, a researcher at the University of Minnesota Center for Bioethics who wasnt involved in the study.

But its impossible to say what patients would get at unregulated clinics offering unapproved stem cell therapies, Turner said by email. In at least two cases unrelated to the current study, patients died after getting stem cell procedures at a clinic in Florida, and in another case at a different Florida clinic, a woman went blind, Turner noted.

Clinics marketing stem cell treatments to patients suffering from heart failure might be administering anything from slurries of mixed cells, some of which might be stem cells, to nothing more than cellular debris, Turner said. Often one can only speculate.

2017 Thomson/Reuters. All rights reserved.

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Clinics Sell Unproven Stem Cell Therapies to Treat Heart Failure: Study - Newsmax

(Reuters Health) - Stem cell therapy isnt approved to treat heart failure in the U.S., but dozens of clinics nationwide advertise the treatments anyway, often charging thousands of dollars for procedures that may not be safe or effective, a new study suggests.

Researchers found 61 centers offering stem cell therapies for heart failure as of last year in the U.S. alone, including five that claimed to have performed more than 100 procedures. Only nine centers required copies of patients medical records and just one facility said it had a board certified cardiologist on staff.

We simply do not know anything about the quality of the treatment delivered at these centers, said senior study author Dr. Paul Hauptman director of heart failure at Saint Louis University Hospital.

These centers are not regulated in any way, Hauptman said by email.

Almost 6 million Americans have heart failure, and its one of the most common reasons older adults go to the hospital, according to the American Heart Association.

It happens when the heart muscle is too weak to effectively pump enough blood through the body. Symptoms can include fatigue, weight gain from fluid retention, shortness of breath and coughing or wheezing. Medications can help strengthen the heart and minimize fluid buildup in the body.

While some experimental stem cell therapies for heart failure are currently being tested in late-stage human trials, none have won approval from the U.S. Food and Drug Administration.

In theory, after a transplant, stem cells could permanently become part of the diseased heart and either help grow new healthy heart tissue or tell existing cells to work better, said Paul Knoepfler, a cell biology researcher at the University of California Davis School of Medicine in Sacramento who wasnt involved in the study.

Its also possible stem cells could temporarily visit the heart and stimulate a positive response in cells already there, he said.

Even though theres no conclusive proof yet that any stem cell treatments are safe and effective for heart failure, centers contacted for the study charge an average of $7,694 for each treatment using patients own stem cells and $6,038 for each procedure with donor stem cells.

In one instance, though, a clinic staff member said, If you have a million dollars to spend we will set you up with weekly infusions.

Hauptmans team had used a standard script when contacting each center, asking about the stem cell treatment itself, medical exams before and afterward and pricing.

Among the other responses they received from clinic staff were remarks such as, If you know anyone that can start an IV, a neighbor that is a nurse for example, we can send you the stem cells and that person can administer them to you and We hope you don't believe your doctor when they tell you there is nothing they can do, you were smart to call us.

None of the sites in the study discussed what methods they used to isolate or identify stem cells, though most claimed to use patients cells and 24 said they got cells from fat tissue.

Most centers claimed to deliver cells intravenously, researchers report in JAMA Internal Medicine.

This approach has been associated with complications such as stroke, in which infused cells block blood vessels in the brain, said Douglas Sipp, a researcher at RIKEN Center for Developmental Biology in Kobe, Japan, who wasnt involved in the study.

The biggest risk is that patients will waste their money, time and hopes on an unnecessary and useless invasive procedure, Sipp said by email.

If any stem cell treatment did ultimately prove safe and effective enough to win FDA approval, it would likely offer a significant improvement over the limited treatment options currently available, said Leigh Turner, a researcher at the University of Minnesota Center for Bioethics who wasnt involved in the study.

But its impossible to say what patients would get at unregulated clinics offering unapproved stem cell therapies, Turner said by email. In at least two cases unrelated to the current study, patients died after getting stem cell procedures at a clinic in Florida, and in another case at a different Florida clinic, a woman went blind, Turner noted.

Clinics marketing stem cell treatments to patients suffering from heart failure might be administering anything from slurries of mixed cells, some of which might be stem cells, to nothing more than cellular debris, Turner said. Often one can only speculate.

SOURCE: bit.ly/2uQve40 JAMA Internal Medicine, online July 24, 2017.

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Dozens of US clinics sell unproven stem cell therapies for heart failure - Reuters

Spinal facet disease is one of the most common causes of neck pain and can cause pain at any level of the spine. The spinal facet joints are located on both sides of the back of each spinal segment. They connect each spinal level and are responsible for stabilizing the vertebral bodies and counterbalancing the intervertebral discs. The facets can be injured during acute trauma often seen in flexion extension injuries such as whiplash or sports accidents. The surfaces of the facet joints are covered by articular cartilage and are also prone to chronic degenerative arthritis much like the larger joints such as knees and hips.

Pain that is caused by facet dysfunction is typically isolated to the back of the lumbar spine, thoracic region and neck. The pain may radiate into the muscles but does not extend into the extremities. Typically, the pain is worsened with extension and or rotation of the neck. Diagnosis of facet pain begins with a physical exam and imaging studies, but often requires diagnostic injection with local anesthetic and or steroid to confirm the diagnosis.

Stem cell treatment of facet disease is a minimally-invasive, out-patient procedure where your own adult stem cells are harvested and injected into the damaged joints to potentially restore structure (disc height), hydration and function, and minimize pain. Dr. Theofilos is one of currently just a handful of pioneers practicing stem cell therapy for degenerative disc disease and facet joint pain in the United States.

We use adipose-derived stem cells, which are harvested from the patients abdominal fat reserves one of the richest sources of mesenchymal adult stem cells. We also harvest stem cells from bone marrow to provide additional regenerative cells. Although bone marrow has fewer stem cells per volume than fat, its unique growth factors and significant hematopoietic cells help to drive tissue regeneration. The procedure is a multi-step process that builds new soft tissue, cartilage, tendon and also halts the degenerative process and further protects the joints.

Voted as one of Americas Top Surgeons, Charles S. Theofilos, MD, Neurosurgeon and Founder of The Spine Center is a leading provider of the state-of-the-art, most comfortable and effective surgical, minimally invasive and non-surgical treatment options for a full range of cervical and spinal ailments, including stem cell therapy and artificial disc replacement. He was among a field of 20 top neuro and orthopedic surgeons in the U.S. chosen to participate in the groundbreaking Artificial Disc Study, which compared the clinical outcome of disc replacement versus traditional spinal fusion. A widely sought after educator and lecturer, Dr. Theofilos has offices in Palm Beach Gardens and Port St. Lucie. In an effort to maintain and honor the commitment to our patients, we will continue to accept Medicare and Medicare Advantage insurance plans for all new and follow up appointments.

_____________________________________

11621 Kew Gardens Ave., Suite 101; Palm Beach Gardens

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Stem cell therapy for disc and facet joint pain - Palm Beach Post

Californias stem cell agency has awarded $5.8 million to University of California San Diego researchers to develop a new variation of cancer immunotherapy.

The California Institute for Regenerative Medicine, or CIRM, approved the grant last week to adapt CAR T cell technology to fight cancer stem cells. These deadliest of cancer cells have stem cell-like properties that enable them to survive treatment and grow profusely. One surviving cell can recreate an entire tumor.

UCSD Moores Cancer Center physicians led by Ezra Cohen will research the therapy to treat a variety of hard-to-treat solid tumors. These include head and neck squamous cell carcinoma, triple-negative breast cancer, pancreatic cancer and ovarian cancers. The preliminary research that yielded this potential treatment was funded by the San Diego-based Immunotherapy Foundation.

CAR T cell therapy, pioneered by Dr. Carl June of the University of Pennsylvania, has been used against blood cancers. While not all of these gravely ill patients have survived, a number have experienced dramatic and long-lasting remissions.

Heres how it works: doctors genetically engineer a patients T cells, part of the immune system, to recognize a protein, called an antigen, on cancer cells so they can destroy them.

The T cells are given what is called a chimeric antigen receptor, or CAR. This is an artificial construct that can recognize the antigen on cancer cells, signaling the immune system to attack. The antigen targeted varies with different versions of the technology.

The T cells are removed from the patient, given the cancer-fighting receptor construct, grown to sufficient numbers, then re-infused into the patient. The cells act as living drugs. They tend to stick around in the patient, ready to grow and attack again if the cancer recurs.

While this has been demonstrated in blood cancers, solid tumors pose a more difficult problem, because immune cells have more limited access to the interior of these tumors.

Cohen, associate director for translational science at UC San Diego Moores Cancer Center, is a specialist in head and neck cancer. Among his patients: Ricki Rockett, the drummer from the band Poison.

Rockett, facing amputation of his tongue when he met Cohen, was given another kind of cancer immunotherapy, two drugs called checkpoint inhibitors that remove a molecular cloak that cancer cells use to hide from the immune system.

The treatment worked. The cancer disappeared, and Rockett kept his tongue.

Its one year after his complete response, and hes still cancer-free, Cohen said. Rockett also went on tour with the band.

Cohen said the newly funded work with CAR T cells builds on earlier UC San Diego research that identified a receptor on some cancer cells as a promising new target. Its made in both solid tumors and blood cancers, but not in normal cells.

The receptor, tyrosine kinase-like orphan receptor or ROR1, is the target of a drug now being tested by Cohens colleague Dr. Thomas Kipps in patients with relapsed or refractory chronic lymphocytic leukemia. The drug, a monoclonal antibody called cirmtuzumab, is named after CIRM, which funded the research that produced the drug.

ROR1 is produced almost exclusively in the embryonic and early fetal stage, and helps the nascent tissues migrate to the right parts of the body, Cohen said. It appears to have virtually no use after that stage. So it appears to be a safe target. Thats been a challenge to find with cancer stem cells, because their genetic activity somewhat resembles that of normal stem cells.

For obvious reasons you don't want to eliminate all the stem cells in a person's body, Cohen said.

Theres some hints ROR1 might be produced in certain precursors to B cells, immune cells that make antibodies, he said. Its possible to live without B cells, as in the case where drugs destroy B cells to stop B-cell lymphoma.

The new project was sparked by Kipps research indicated ROR1 was produced in high amounts in the hard-to-treat cancers. Cohen, a specialist in head and neck cancer, began thinking of how this knowledge could be applied with CAR T-cell technology

Cohen said preclinical research has already been performed for the new project. In cell culture tests, CAR-T cells with the ROR1 receptor kill cancer stem cells with the receptor in those difficult cancers.

Funding for that research came from the Immunotherapy Foundation, created by San Diego philanthropists Ralph and Fernanda Whitworth in 2015 after Ralph Whitworth was diagnosed with cancer. He died of the disease in September 2016.

Christina Martinez, the Immunotherapy Foundations executive director, said Whitworth met with Cohen after his diagnosis, and became personally interested in advancing the research.

It was a serendipitous encounter, but he really saw the potential for a lasting partnership in his ability to be able to make a long-term contribution to the area of immunotherapy, Martinez said. This project was just one that fell under kind of an umbrella of projects that he was interested in and funding at UCSD. So he and Fernanda seeded that initial investment.

To further improve cancer immunotherapy, the Whitworths established the Immunotherapy Foundation. Fernanda Whitworth, president and co-founder, said shes pleased with the progress.

Ralph and I liked that these projects were designed to be tightly interconnected to leverage information and allow efficient movement into the clinic, she said. Today, I am proud to see this rational, focused approach is working.

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Cancer stem cells target of new grant to UCSD scientists - The San Diego Union-Tribune

Sacramento Bee

California stem cell agency researching cures for brain cancer afflicting McCain Sacramento Bee Earlier this year, Karen Ring, a stem cell scientist and overseer of CIRM's social media, wrote on the agency's blog about a notable, early-stage clinical trial involving glioblastoma. She described the work as a new cell-based therapy that melted ... CIRM Approves $5.8 Million Grant for CAR-T Therapy That Targets Cancer Stem CellsNewswise (press release) $5.8M to Help UCSD Develop Cancer Stem-Cell DrugsTimes of San Diego all 3 news articles »

Originally posted here:

California stem cell agency researching cures for brain cancer afflicting McCain - Sacramento Bee

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At ClinicalTrials.Gov, Untested Stem Cell Clinics Advertise for Free ... - WIRED

Paul Knoepfler PhD is disturbed and concerned. Heres why.

Knoepfler is a stem cell researcher and professor at the University of California-Davis School of Medicine. Over the past couple of years he has noticed more and more big budget ads for unproven stem cell therapies showing up in major American newspapers, such as these:

From left, clockwise: ads from the San Francisco Chronicle, Sacramento Bee, and Seattle Times

Perusing a dozen or so of these adsand some are full-page spreadsyou begin to see some common promises, such as

Many of the ads also include coupons or offer free seminars that qualify people for discounted treatments (discount amount stated; full price not stated).

Paul Knoepfler PhD

Most of the clinics advertised promise to treat dozens of very different problems. The three most common include orthopedic issues (pain in every major joint from your ankles up to your neck), neurologic diseases (including Parkinsons, stroke, traumatic brain injury, multiple sclerosis, and amyotrophic lateral sclerosis or ALS), and a host of autoimmune diseases (like rheumatoid arthritis, Crohns disease, and lupus).

Can a single treatment do all this? (And more, including effective treatment of COPD, blindness, depression, and diabetes, to name a few).

The short answer is no,' says Knoepfler, whos been following the boom of hundreds of stem cell clinics across the country in his blog.

Hypothetically, stem cells of various kinds could help a lot of different conditions. But it doesnt make sense that just one type of stem cell like from fat or bone marrow could treat a variety of conditions from head to toe. Both from a scientific and common sense perspective, how would some fat cells help your vision if they were squirted in your eyeball? The logic and evidence is missing. But you could imagine if you were losing your vision, and were desperate, you might be willing to take more risks.

Jeanne Loring Phd

Jeanne Loring PhD, is a stem cell researcher and professor at the Scripps Research Institute.

She agrees with Knoepfler that, not only are some vulnerable people being preyed upon, but the claims made in the advertising are not backed by science.

Much of what is being injected arent even stem cells. And the ones were told come from fat or bone marrow arent even capable of living in our bodies beyond one day. And they certainly cant turn into heart cells, or neurons, or retinal cells like they may claim.

Whenever I see the people who run these clinics they run away from me. They dont want to talk to real scientists. They dont want to their approaches questioned. Because 99 percent of them know theyre pulling the wool over peoples eyes. This is marketing, not science. Ask yourself: Why are they advertising in the newspaper?

Leigh Turner PhD

And just as important, how are they getting away with it?

Leigh Turner PhD is a bioethicist at the University of Minnesota. It was Turner, along with Knoepfler, who in 2016 documented at least 351 stem cell businesses nationwide pushing unproven stem cell therapies. He says the widely held notion that these stem cell clinics only exist overseas is now clearly outdated.

The central issue in his opinion is: Where is the oversight?

Its not just about desperate people losing lots of money, its about genuine and tangible harms being done. Yet we have this growing market where people can make these dramatic marketing claims about unlicensed and unproven treatments without evidence, without safety data, and without proof of efficacy. Theres a lack of regulatory activity that is basically operating like a green light for these clinics and this kind of advertising to pour into the marketplace. Where is the FDA? The FTC? The consumer protection agencies? And what about the state medical boards?

From an Alaska Airlines inflight magazine

You may be wondering: If these ads are promoting unapproved treatments, then what are stem cells legitimately used for? The FDA has approved stem cells for use in a handful of transplant procedures, some cancers, as well as some immunologic and blood disorders. Unfortunately, as all the researchers I spoke with mentioned, the current hype generated by unproven treatments often draws attention away from legitimate research and advances in stem cell therapy.

But guidance in navigating this complex topic is available. Here are 3 excellent starting points:

And, lest we forget, there are real people at the core of this story. Last week I intervieweda man left permanently blinded by a retinal stem cell procedure that he was told helped 100 percent of people and helped them read at least 2 or 3 more lines on the eye chart.

Now he cant even read the big E at the top of the chart from an arms length away.

That man is George Gibson. And next week, in a special podcast were thinking of calling The Wild West of Stem Cells, youll hear more of Gibsons story, as well as more from the scientists quoted above.

Its the story these advertisements dont tell you.

Only 7 percent of orthopedic surgeons in the United States are women. Dr. Julie Switzer

If you had been in Salt Lake City last month, savoringyour morningcoffee, and watching this

The segment on the WFAA-TV, Dallas, Good Morning Texas program, was headlined "The latest on

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Stem cell ads: Promise much, deliver little - HealthNewsReview.org

Stem cell research for diabetes

Jaime Berg, KUSA 5:06 PM. MDT July 19, 2017

Courtesy: Holger Russ, Barbara Davis Center Description: Cell clusters floating in culture media during generation of insulin-producing cells from human stem cells.

KUSA - Theres some major diabetes research happening right here in Colorado.

Researchers at the Barbara Davis Center on the University of ColoradoAnschutz Medical campus in Aurora are using stem cells to eventually rid diabetics of having to inject insulin on a daily basis.

For people with Type 1 diabetes, a lack of insulin can be life-threatening.

If someone doesnt have access to insulin, they could die. Its something people with Type 1 diabetes have to think about on a daily basis.

Courtesy: Holger Russ, Barbara Davis Center Description: Immunofluorescence image of a section cut through a cluster.

With work being done at the Barbara Davis Center, the eventual hope is that patients can have an injection of stem cells that do the insulin regulating for them.

According to Holger Russ, an assistant professor at the Barbara Davis Center, people who have to take insulin have to be aware of their levels every day, so this stem cell therapy approach could ultimately change the way they live their lives.

It impacts every day, they always have to have their supplies ready," Russ said. "Its a constant thing on their minds.with the cell therapy approach what we are working on this will be gone.

The end result is still several years in the making, but researchers say theyve started to lay the groundwork and are on their way to creating a better life for Type 1 diabetes patients thats as many as three million Americans.

Testing is underway, but it will take several years for the approach to be approved for use.

Russ says this sort of stem cell therapy is already a decade in the making, and that it could be used within our lifetimes. He says ultimately, his end goal is to prevent Type 1 diabetes and predict it.

To generate functional cells that are better and better, and use the cells in what goes wrong in a person with the disease, and then we can find the drugs to help prevent type one diabetes from occurring in a patient, Russ said.

Research conducted at the Barbara Davis Center is largely supported by the Children's Diabetes Foundation.

2017 KUSA-TV

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Researchers in Colorado are hoping stem cells can help those with diabetes - 9NEWS.com

> In an article published today in the journal Regenerative Medicine, it turns out that the federal clinical-trials database ClinicalTrials.gov has allowed 18 ostensible clinical trials of unregulated stem cell therapies, that patients must to pay to enroll, to go up on its site. The article argues that some stem cell clinics are using the site as a marketing tool, claiming that their unapproved meds could potentially help an array of patients. Author Leigh Turner, an associate professor at the University of Minnesotas Center for Bioethics and School of Public Health, says: Absent meaningful changes, it seems likely that there will be more reports of patients harmed after paying for unapproved stem cell interventions that first came to their attention on ClinicalTrials.gov. Regenerative Medicine article.

> Context Therapeutics has hired Erard Gilles M.D., M.Sc., as its new chief medical officer, leaving his former CMO role at Invivis Pharmaceuticals to join the biotech, which is focused on work for Sigma1-related diseases. Gilles will oversee clinical development while taking the lead of its clinical trial strategy. While at Invivis, he developed an anti-progestin therapy and biomarker that was later licensed by Arno Therapeutics. He has around 30 years in the industry, with stints at J&J and Roche, among others.Release.

> UroGen Pharma has seen its bank balance jump by $7.5 million after a biobucks pay out from partner Allergan. This comes after the pharmas recent submission of an FDA IND app for RTGel, in combo with its Botox med, in overactive bladder disorder. Our licensing agreement with Allergan for the use of our RTGel in combination with Botox continues to be productive with the recent achievement of this important IND submission, said Ron Bentsur, CEO at UroGen. Statement.

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News of NoteDodgy stem cell clinics; New CMO for Context; UroGen payday - FierceBiotech

In the days after a heart attack, surviving patients and their loved ones can breathe a sigh of relief that the immediate danger is overbut the scar tissue that forms during the long healing process can inflict lasting damage. Too often it restricts the heart's ability to fill properly between beats, disrupting rhythm and ultimately leading to heart failure. Yet a new possible treatment may help to revitalize an injured ticker.

A cadre of scientists and companies is now trying to prevent or reverse cardiac damage by infusing a cocktail of stem cells into weakened hearts. One company, Melbourne, Australiabased Mesoblast, is already in late-stage clinical trials, treating hundreds of chronic heart failure patients with stem cell precursors drawn from healthy donors' hip bones. A randomized trial that includes a placebo group is scheduled to complete enrollment next year.

Mesoblast's earlier-stage trials, published in 2015 in Circulation Research, found that patients who received injections of its cell mixture had no further problems related to heart failure.

Promising results from the new trial would be a major step forward for a field that has long been criticized for studies that are poorly designed, incomplete or lack control-group comparisons, as well as for the peddling of unproved therapies in many clinics worldwide.

Another company, Belgium-based TiGenix, hopes to attack scar tissue before it forms by treating patients with a mixture of heart stem cells within seven days of a heart attack. This approach has just completed phase II trials, but no findings have yet been published.

There are still many unanswered questions about how stem cellstypically derived from bonescould help heal the heart. Leading theories suggest they may help fight inflammation, revitalize existing heart cells, or drive those cells to divide or promote new blood-vessel growth, says Richard Lee, leader of the cardiovascular program at the Harvard Stem Cell Institute. Other stem cell scientists, including Joshua Hare, who conducted earlier-stage Mesoblast research and directs the Interdisciplinary Stem Cell Institute at the University of Miami, say the cells may work in multiple ways to heal scar tissue. According to Hare, the stem cells could ultimately be a truly regenerative treatment.

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Stem Cell Therapy for Heart Failure Gets a Gold-Standard Trial - Scientific American

Umbilical cord-derived stem cells failed to improve lupus patients impaired kidney function, according to a small clinical trial in China whose results contrasted with previous studies.

The research, A randomised double-blind, placebo-controlled trial of allogeneic umbilical cord-derived mesenchymal stem cell for lupus nephritis, was published in Annals of the Rheumatic Diseases.

Forty to 77 percent of systemic lupus erythematosus patients have reduced kidney function, according to estimates. The condition, known as lupus nephritis, is linked to increased lupus severity and mortality.

Traditional nephritis treatments include immunosuppressive drugs such as steroids, intravenous cyclophosphamide, and mycophenolate mofetil.

As increasing number of studies are examining stem cells as a therapy, however, with a particular focus on human umbilical cord-derived mesenchymal stem cells, or hUC-MSCs. But few randomized clinical trials have examined hUC-MSC as a nephritis treatment.

Researchers decided to evaluate hUC-MSC s effectiveness in a randomized, double-blind trial (NCT01539902) at a medical center in Kunming, China.

The team recruited 18 lupus patients, 16 years or older, with lupus nephritis. Each patients lupus fell into the World Health Organizations Class III or IV disease categories.

Patients were randomly assigned to either hUC-MSC or a placebo. The treatment group was 11 patients and the placebo group six.

All of the patients also received standard immunosuppressive treatment: intravenous methylprednisolone and cyclophosphamide, followed by maintenance with oral prednisolone and mycophenolate mofetil.

Researchers checked the patients nephritis every two weeks for the first two months of the 12-month trial, then every month for two to six months, and finally every two months until the end of the study.

The main goals of the trial were to stabilize patients nephritis by achieving either full or partial remission of the condition, improving their kidney function, or reducing red blood cell and protein levels in their urine. High levels of those components are markers of kidney impairment.

All but one of the 18 patients completed the trial. The one who didnt died three months after enrolling.

Patients who received hUC-MSC experienced no more benefits than the placebo group, the researchers reported. Nine of the 12 treated patients, or 75 percent, achieved remission, versus five of the six placebo patients, or 83 percent.

In addition, measures of nephritis improvement were similar in the two groups. These included kidney function, Systemic Lupus Erythematosus Disease Activity Index scores, British Isles Lupus Assessment Group scores, and levels of serum albumin.

Overall, the trial showed that lupus patients treated with hUC-MSC obtained no benefits beyond those that standard immunosuppression delivered. The bottom line was that the therapy failed to replicate benefits of previous hUC-MSC studies of lupus nephritis.

The trial was abandoned after 18 patients were enrolled when it had become obvious that the trial would be unlikely to demonstrate a positive treatment effect for hUC-MSC, the researchers said.

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Stem Cell Therapy Fails to Improve Lupus Patients' Kidney Impairment, Study Shows - Lupus News Today

A treatment targeting wayward immune cells in people with Type 1 or Type 2 diabetes may help even years later, a new study finds.

For the treatment, researchers take blood from a person with diabetes and separate out the immune system cells (lymphocytes). They briefly expose those cells to stem cells from umbilical cord blood from an unrelated infant. Then they return the lymphocytes to the patient's body.

The researchers have dubbed this treatment "stem cell educator therapy," because when exposed to the stem cells, the errant lymphocytes seem to re-learn how they should behave.

"Stem cell educator therapy is a safe approach" with long-term effectiveness, said the study's lead author, Dr. Yong Zhao, an associate scientist at Hackensack University Medical Center in New Jersey.

Type 1 diabetes, an autoimmune disease, occurs when the body's immune system cells mistakenly attack the insulin-producing (beta) cells in the pancreas. This leaves people with Type 1 diabetes with little to no insulin. They need insulin injections to survive.

Researchers have long thought that any cure for Type 1 diabetes would have to stop the autoimmune attack, while regenerating or transplanting beta cells.

But Zhao and his team developed a new approach to the problem educating the immune cells that had been destroying beta cells so they stop attacking.

In Type 2 diabetes, Zhao said immune cell dysfunction is responsible for chronic inflammation that causes insulin resistance. When someone is insulin-resistant, their body's cells can't properly use insulin to usher sugar from foods into cells for use as energy. Instead, the sugar builds up in the blood.

The researchers hoped the stem cell educator would help decrease insulin resistance for people with Type 2 diabetes.

In earlier trials, the treatment showed significant promise with up to a year of data. The researchers also showed that the treatment was safe.

The current study looked at four years of data on nine Type 1 diabetes patients in China.

To see how well the treatment works, the researchers measured C-peptide, a protein fragment that's a byproduct of insulin production.

Two people with Type 1 diabetes who received a stem cell educator treatment shortly after diagnosis (five and eight months later) still had normal C-peptide production and didn't need insulin four years after a single treatment.

Another Type 1 patient had had the disease for four years when she got a treatment. She still had improvements in her C-peptide levels, but wasn't considered in remission. The remaining six people with Type 1 saw decreases in their C-peptide levels over time. The study authors said this suggests more than one treatment might be needed.

"Because this was a first trial, patients just got one treatment. Now we know it's very safe so patients can receive two or three treatments," Zhao said.

Researchers also looked at six patients with severe, long-standing (15-24 years) Type 2 diabetes. They found that one treatment helped four patients achieve normal C-peptide levels and maintain them over the four-year follow-up.

Zhao said the treatment could help with other autoimmune diseases, too.

Julia Greenstein is vice president of discovery research at JDRF (formerly the Juvenile Diabetes Research Foundation).

"This research is intriguing," she said, "but it needs to be reproduced."

Both Zhao and Greenstein noted that diabetes seems to differ slightly in Chinese populations from Western ones. So, it's not yet clear if this treatment would be as beneficial for people of European descent.

To find out, Zhao plans to conduct a clinical trial of the new treatment with people with Type 1 diabetes at Hackensack Medical Center.

The study was recently published in Stem Cells Translational Medicine.

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New diabetes treatment teaches rogue immune cells to behave - Chicago Tribune

Considering the mushrooming of stem cell clinics offering "cures" for conditions ranging from diabetes to autism across the country, the Indian Council for Medical Research (ICMR) and the Department of Biotechnology (DBT) have come up with guidelines on who can conduct research in this sphere, when and how. Moreover, the draft, for the first time, provides guidelines for cutting-edge gene editing techniques.Giving a three-page list of conditions for which stem cells can be offered, the draft omits conditions such as motor neuron disease, mental retardation or muscular dystrophy . It makes it clear that doctors should stick to their specialty. "Doctors cannot criss-cross areas of specialization," said ICMR deputy director general Dr Geeta Jotwani. "At present, there are orthopaedic surgeons who offer so-called stem cell therapy for neurological problems or vice-versa. We are now clearly saying that only clinicians with subject domain can offer clinical trials."

The 40-page draft is available on the ICMR and DBT's websites, and is open to public comments and concerns till July 31. "Stem cells have a lot of potential in disease management. Our last guidelines came out in 2013, but a lot has changed since then, making us feel the need to update our guidelines. We want to encourage people to do research in stem cells, but at the same time want to ensure nothing unethical is carried out," ICMR director general Dr Soumya Swaminathan told TOI.

On the mention of gene editing techniques, she said, "We want our researchers to take up work in this field. US researchers have been working on gene editing for cancer, HIV, etc, but we in India haven't yet come to that point. We have included CRISPR-Cas9 (gene editing tool) in the guidelines, but only for research in somatic (normal or non-reproductive) cells."

The rest is here:

Read these new rules before going in for a 'stem cell cure' - Times of India