Stem Cell Clinic

FDA Cracks Down on ‘Unscrupulous’ Stem Cell Clinics – New York Times

By Stem Cell Medical Center

On Friday, the agency said, federal marshals seized 500 doses of live Vaccinia virus vaccine for smallpox belonging to StemImmune Inc., a San Diego firm that develops stem cell-based immunotherapies for cancer. The raid came after the F.D.A. learned that the vaccine was being used to create an unapproved stem cell product, a combination of excess amounts of vaccine and stem cells derived from body fat, which was then administered to cancer patients with potentially compromised immune systems.

The F.D.A. said patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, Calif., received the treatment made with the smallpox vaccine. It also said it had serious concerns about how StemImmune obtained the vaccine for use in an unapproved and potentially dangerous treatment.

StemImmune obtained at least some of the vaccine from the Centers for Disease Control and Prevention, according to Thomas Skinner, a C.D.C. spokesman. In its request, the company said it was conducting cancer research involving the vaccinia virus, and needed to vaccinate researchers a seemingly legitimate reason. The company did not tell the C.D.C. that it was going to inject the vaccine into patients, he said.

A statement from StemImmune said the company had lawfully obtained the drug.

The F.D.A. also issued a warning letter to U.S. Stem Cell, a private clinic in Sunrise, Fla. The company was the subject of a March report in The New England Journal of Medicine, describing how one woman went blind and two others suffered severe, permanent eye damage after being given shots of stem cells, extracted from fat, into their eyes.

The warning letter accused the company of impairing the F.D.A.s ability to conduct its inspection by refusing to allow inspectors in, and denying them access to employees. It also said that U.S. Stem Cell had failed to establish proper quality control and sanitary standards.

In a statement Monday afternoon, U.S. Stem Cell denied ever restricting access to F.D.A. inspectors, or having sterility problems. The safety and health of our patients are our number one priority and the strict standards that we have in place follow the laws of the Food and Drug Administration, it said.

Noting that the F.D.A. has asked patients with concerns to come forward, the company said it had asked patients who have had positive experiences with their stem cell treatments to notify the agency.

But in the warning letter, the F.D.A. noted that U.S. Stem Cell had claimed its work was not subject to agency regulation. The F.D.A. disagreed, saying that the cells extracted by the company met the definition of both a drug and a biological product, both of which come under the agencys jurisdiction. In its statement, U.S. Stem Cell said it would abide by the new rules the agency is developing for the field.

Dr. Gottlieb said it was imperative to shut down fraudulent and unsafe players in the field in order to take advantage of the promise of stem cell therapies and to increase innovation in the regenerative medicine field, a program authorized by Congress in the 21st Century Cures Act.

Those enterprises put the entire field at risk, Dr. Gottlieb said. Products that are reliably and carefully developed will be harder to advance if bad actors are able to make hollow claims and market unsafe science.

The California Stem Cell Treatment Centers were founded in 2010 by Dr. Mark Berman, a plastic surgeon, and Dr. Elliot Lander, a urologist. Dr. Berman defended the company, and said that the F.D.A. had not accurately interpreted its cancer pilot study with StemImmune. Dr. Berman, who is also a director of StemImmune, also said that none of the patients had experienced serious adverse effects or died as a result of the treatment involving the vaccine, which he noted, was free.

Dr. Berman and Dr. Lander also train other physicians to perform liposuction, extract stem cells from the fat and inject the cells to treat many ailments, including heart disease, back and knee pain, asthma and neurological disorders.

After training, the physicians can become affiliates of the Cell Surgical Network, which has more than 60 members around the country. Patients are charged $8,900 per procedure, Dr. Berman said in a previous interview. He said affiliates purchase a centrifuge and incubator from the network for about $29,000, and pay the network $1,000 for the disposable liposuction equipment needed for each procedure.

A Florida woman, Doris Tyler, 77, lost her sight after being treated last September at an affiliate of the Cell Surgical Network, the Ageless Wellness Center in Peachtree City, Ga. Cells from her fat were injected into both eyes.

Before the treatment, Mrs. Tylers sight had deteriorated because of age-related macular degeneration. But she said she could still see well enough to get around, cook and read.

Within a month of the injections, Mrs. Tyler had a retinal detachment and lost the sight in her left eye. A few weeks later, the same thing happened to her right eye.

She consulted Dr. Thomas Albini, an eye surgeon at the Bascom-Palmer Eye Institute at the University of Miami, who had also examined the three women who went blind after similar treatment at the U.S. Stem Cell Clinic.

In an interview, Dr. Albini said Mrs. Tylers case resembled the others. The stem cells apparently formed a membrane that pulled the retina off the back of the eye, causing blindness. Attempts to reattach the retinas surgically could not restore Mrs. Tylers sight. She was permanently blinded.

Calls to the clinic in Peachtree City were not returned.

Dr. Berman said that because of her case, affiliates of the Cell Surgical Network were being advised to avoid giving injections directly into the eyes.

We made a bad decision to have this done, Mrs. Tylers husband said.

Dr. Gottlieb said the F.D.A. would soon publish documents detailing which new treatments and products are subject to agency regulation, and which are not, and giving details on a new, expedited path for companies with legitimate products, seeking premarket approval.

Some industry representatives applauded the move.

The F.D.A.s proposal is clear evidence of the fact that the regenerative medicine sector has matured and has moved from just a research sector to a development of market ready products, said Michael Werner, a partner in the law firm of Holland & Knight and the executive director of the Alliance for Regenerative Medicine. Hes clearly distinguishing unscrupulous actors who are playing upon hype and taking advantage of patients and product developers who are actually going to treat diseases.

He is trying to balance patient safety and a regulatory pathway that is as least burdensome as possible, Mr. Werner said.

Public health advocates praised the F.D.A. for moving against the companies, but said it should have happened sooner, given the widespread knowledge of public harm.

We certainly welcome this type of action, although it comes belatedly, said Dr. Michael Carome, director of Public Citizens Health Research Group. The agency has known about these unscrupulous actors for years.

Because of an editing error, an article on Tuesday about a Food and Drug Administration crackdown on stem cell clinics omitted comments from two of the companies cited StemImmune in San Diego and California Stem Cell Treatment Centers in Rancho Mirage, Calif., and Beverly Hills. It is not the case that the companies did not respond to requests for comment. The article reported that the F.D.A. had serious concerns about how StemImmune obtained hundreds of doses of small pox vaccine containing live Vaccinia virus for use in an unapproved and potentially dangerous stem cell treatment. A statement from StemImmune said the company had lawfully obtained the drug. The article also reported that patients at the California Stem Cell Treatment Centers received the treatment made with the smallpox vaccine. In response, Dr. Mark Berman, one of the founders of the centers, said that the F.D.A. had not accurately interpreted a cancer pilot study that the centers conducted with StemImmune. Dr. Berman, who is also a director of StemImmune, said that none of the patients had experienced serious adverse effects or died as a result of the treatment, which he noted was free.

A version of this article appears in print on August 29, 2017, on Page A17 of the New York edition with the headline: F.D.A. Cracks Down On Stem Cell Clinics It Calls Unscrupulous.

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FDA Cracks Down on 'Unscrupulous' Stem Cell Clinics - New York Times

Creative Medical Technology Holdings Achieves 100% Patient … – Markets Insider

By Stem Cell Medical Center

PHOENIX, Aug. 28, 2017 /PRNewswire/ -- Creative Medical Technology Holdings Inc. (OTCQB ticker symbol CELZ) announced today completion of enrollment in the Company's clinical trial assessing safety and efficacy of its CaverstemTM procedure to treat erectile dysfunction in patients who do not respond to currently available treatments.Approximately 30% of the 30,000,000 patients suffering from erectile dysfunction do not respond to drugs like Viagra, Cialis and Levitra, in part due to an underlying degeneration of the biological machinery needed to achieve erections.

"The CaverstemTM procedure, which uses the patient's own bone marrow derived stem cells to induce arterial and venous regeneration, is an outpatient procedure able to be conducted by Urologists in their medical facilities. We are using a patient's own cells and we do not manipulate the stem cells through the use of chemicals, growth factors or expansion and have experienced no procedure-related safety issues," said Dr. Thomas Ichim Co-Founder and Chief Scientific Officer of Creative Medical Technology Holdings, Inc.

The clinical trial covering patients ages 18 to 80 received Institutional Review Board (IRB) approval in December 2016. The trial is sponsored by us based on our patented technology and is conducted by Dr. Jacob Rajfer, Principal Investigator and Los Angeles Biomedical Institute at Harbor UCLA Hospital in Torrance, CA.

"I am pleased with the expedience and efficiency at which enrollment was reached. As someone who regularly sees patients suffering from treatment non-responsive erectile dysfunction, I am excited to see the development of a novel approach to treating this condition using the patient's own natural regenerative processes," said Dr. Alexander Gershman, member of the Company's Scientific Advisory Board and Director of Institute of Advanced Urology at the Cedars-Sinai Medical Tower; Director of Urologic Laparoscopy in the Division of Urology, Harbor-UCLA Medical Center."

"We are very fortunate to work with the expert team at Los Angeles Biomedical Institute - UCLA/Harbor Hospital who have done an outstanding job with subject recruitment, screening, treatment and follow-up.We firmly believe that we are on schedule for commercialization of the Caverstem TM procedure through publication and presentation of trial results, marketing, licensing, training and sales in 2018," said Timothy Warbington, President and CEO of Creative Medical Technology Holdings Inc.

About Creative Medical Technology Holdings

Creative Medical Technology Holdings, Inc. is a clinical stage biotechnology company currently trading on the OTCQB under the ticker symbol CELZ. For further information about the company go to http://www.creativemedicaltechnology.com. For more information on our CaverstemTM procedure please go to http://www.caverstem.com.

Forward-Looking Statements

OTC Markets has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This news release may contain forward-looking statements including but not limited to comments regarding the timing and content of upcoming clinical trials and laboratory results, marketing efforts, funding, etc. Forward-looking statements address future events and conditions and, therefore, involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements. See the periodic and other reports filed by Creative Medical Technology Holdings, Inc. with the Securities and Exchange Commission and available on the Commission's website at http://www.sec.gov.

View original content:http://www.prnewswire.com/news-releases/creative-medical-technology-holdings-achieves-100-patient-enrollment-in-caverstemtm-clinical-trial-for-stem-cell-treatment-of-erectile-dysfunction-300509805.html

SOURCE Creative Medical Technology Holdings, Inc.

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Young cardiac cells rejuvenate heart in animal study – The San Diego Union-Tribune

By Embryonic Stem Cells

Cardiac predecessor cells appear to rejuvenate the hearts of older animals, according to a recent study from Cedars-Sinai Heart Institute that may lead to tests in humans.

Signs of rejuvenation in rats included a 20 percent increase in exercise capacity, faster regrowth of hair, and lengthening of the protective caps of chromosomes.

The study used cardiosphere-derived cells, or CDCs, which are like stem cells, but can only develop into heart cells. These cells are already being used in a human clinical trial to repair damage from heart attacks. The trial is being conducted by Beverly Hills-based Capricor in several hospitals, including Scripps La Jolla.

Since these cells have already been found to be safe, it should be fairly straightforward to extend testing from repairing heart damage in people to rejuvenation, said study leader Dr. Eduardo Marbn. Hes director of the Los Angeles Institute, part of Cedars-Sinai Medical Center. Marbn is also a co-founder of Capricor, publicly traded on Nasdaq.

However, a researcher not involved in the study said that while it was well done, the history of stem cell treatments indicates that proving efficacy in people promises to be far more difficult.

The study used cells taken from newborn rats, injected into the hearts of older, senescent rats. It was published Aug. 14 in the European Heart Journal.

The study is exceptional in both its scope and breadth, said Dr. Richard Schatz, a Scripps Clinic cardiologist involved in the Capricor trial at Scripps La Jolla.

It examines an extraordinary number of variables rarely seen in such studies to ask the question of the impact of CDC (specialized stem cells) on cardiac aging in rats, Schatz said by email. Every parameter of how aging might be studied moved in the right direction, meaning there might be a biologic effect of their cells throughout the body.

Schatz cautioned that scientific excellence doesnt equal clinical success.

The technologys muscle-improving effectiveness could also help patients with Duchenne muscular dystrophy, Marbn said. That use is in clinical testing by Capricor. Early results in patients have been promising enough that more studies are planned.

Capricor clinical trial information is available at http://capricor.com/clinical-trials.

Marbn said the study adds to growing evidence that progenitor cells exert their healing power by secreting chemicals that stimulate repair, not by permanently incorporating themselves into the body. The chemicals are enclosed in tiny vesicles called exosomes that the cells shed.

Until fairly recently, exosomes were dismissed as cellular debris, but are now being appreciated for their role in cell signaling, Marbn said.

There's a staggering number, something like 100 billion to a trillion exosomes per drop of blood, per drop of cerebrospinal fluid, Marbn said. They are plentiful in breast milk. The only thing we know right now is that there is a complex signaling system.

These exosomes travel far beyond the heart to reach skeletal muscle, which is weakened in Duchenne muscular dystrophy, he said.

Schatz said the study provides evidence that the cells exert many different effects beyond those in a single target organ, through the exosomes, seen in humans as well.

This is very good news if you are a rat, but the obvious limitation is how will this play out in humans, Schatz said.

Previous clinical trials of stem cells have been successful in Phase 1 and 2, Schatz said, but fail in Phase 3. So the researchers face a daunting road ahead to demonstrate usefulness in people.

This does not take away from the brilliant science behind this exceptional group of investigators, Schatz said. They should be congratulated for a very thoughtful and expansive look at a fascinating subject, the clinical relevance of which remains to be seen.

The rejuvenation effects to some degree resemble cells created when adult cells are reprogrammed back to being stem cells, Marbn said.

Certain factors are turned on that regress the cells to act like embryonic stem cells. These are called induced pluripotent stem cells, because they can become nearly any cell in the body, a property called pluripotency.

Something like this might be happening through exosome-mediated reprogramming.

We have a suspicion that even though we didn't go about trying to activate those factors, some of them may in fact be turned on by the therapy, Marbn said.

Understanding precisely what is going on will take much more work to sort out, he said. For example, lengthening the protective caps of chromosomes, or telomeres, is presumably caused by production of telomerase, an enzyme that makes them longer. But how?

Knowing the exosomes are involved doesnt narrow it down very much, he said.

We think that there's thousands and thousands of different bioactive molecules within exosomes. And so I can't right now point to, let's say, these five RNAs and say, they're the ones that we think are doing the trick, Marbn said. But somewhere in the genetic instructions in the exosomes are signals that cause telomerase to be activated and elongation of the telomeres.

Even without understanding the precise mechanism, the demonstrated results have been promising enough for Capricor to continue clinical testing in Duchenne muscular dystrophy, Marbn said, even though its outside the companys initial focus on heart disease.

The heart attack research gave mixed messages, he said. Capricor isnt abandoning it, but has given priority to the muscular dystrophy program.

Duchenne muscular dystrophy patients and their parents are more interested in increasing skeletal muscle function than heart function, he said. The disease virtually exclusively affects males, and they often die when quite young.

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Young cardiac cells rejuvenate heart in animal study - The San Diego Union-Tribune

FDA moves to curb dangerous stem cell clinics – Philly.com

By Stem Cell Medicine

The U.S. Food and Drug Administration on Monday announced a crackdown on deceptive and dangerous stem cell clinics, starting with actions against a California company accused of giving smallpox vaccine to cancer patients, and a Florida company that ruined the eyesight of three women.

Our actions today should also be a warning to others who may be doing similar harm, FDA Commissioner Scott Gottlieb said in a statement, urging consumers and health-care providers to report rogue clinics and injuries.

FDA Commissioner Scott Gottlieb

The California company, San Diego-based StemImmune Inc., was combining the vaccine with stem cells derived from fat, then giving it intravenously or injecting it into tumors of cancer patients at clinics in Rancho Mirage and Beverly Hills, Calif., the FDA said.

U.S. marshals on Friday seized five vials of smallpox vaccine, including one that was partially used. The agency is investigating how the company obtained the vaccine, which has been stockpiled by the government in case of a bioterrorist attack.

The vaccine is made with live vaccinia virus, a poxvirus similar to but less harmful than smallpox. The vaccine could cause life-threatening problems in immune-compromised cancer patients, and alsoin certain unvaccinated people who might be accidentally infected by the patients, the FDA explained.

Speaking as a cancer survivor, Gottlieb said in a statement, I know all too well the fear and anxiety the diagnosis of cancer can have and how tempting it can be to believe the hollow claims made by these kinds of unscrupulous clinics. The FDA will not allow deceitful actors to take advantage of vulnerable patients.

In a separate enforcement action, the FDA sent a warning letter last week to U.S. Stem Cell Clinic of Sunrise, Fla., saying it could face product seizure or an injunction. Agency inspectors found that the clinic was processing fat-derived stem cells and claiming to treat a raft of conditions, including Parkinsons disease, amyotrophic lateral sclerosis (ALS), rheumatoid arthritis, diabetes, and heart failure.

In March, U.S. Stem Cell made headlines when an article in the New England Journal of Medicine reported that three women with age-related macular degeneration suffered severe and permanent vision damage one was blinded after stem cells were injected into their eyeballs at the clinic. The article was written by doctors unconnected with the clinic who treated the women for the disastrous results.

Critics of unapproved stem cell treatments have called for tougher oversight by the FDA, as well as by the Federal Trade Commission, which regulates advertising, and by state medical boards, which oversee the practice of medicine.

The regulatory moves come as so-called regenerative medicine is exploding, spawning an industry built on unproven treatments using stem cells from bone marrow or fat. In recent months, networks of chiropractors have run big-budget ads for such treatments in newspaper across the country, including the Inquirer. Those ads, however, focus on addressing orthopedic problems such as degenerative discs and arthriticknees.

The only FDA-approved stem cell therapies involve using cells from bone marrow or umbilical cord blood to treat blood cancers and certain immune disorders. In general, biologic tissues that are processed and marketed as therapies are supposed to go through the FDAs drug approval process, which involves years of costly clinical testing in humans.

However, the FDA has tried to find a middle ground, recognizing the potential promise of stem cells in tissue repair and regeneration. The FDA has published, but has not finalized, draft guidance for stem cell products, saying they can be exempted from the drug approval process under certain scenarios. Among other criteria, the cells must be minimally manipulated and used in a homologous way, meaning for the same function they perform naturally in the body.

In a policy statement issued Monday, Gottlieb promised that this fall, the agency will advance a comprehensive policy framework that will more clearly describe the rules of the road for this new field. It will enable responsible product developers to gain FDAapproval with minimal burdens and costs.

We want to facilitate innovation, he wrote.

Published: August 28, 2017 4:42 PM EDT

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FDA moves to curb dangerous stem cell clinics - Philly.com

Why Doug Baldwin went to England for stem-cell therapy – The News Tribune (blog)

By Stem Cell Medicine

The News Tribune (blog)
Why Doug Baldwin went to England for stem-cell therapy
The News Tribune (blog)
RENTON Turns out, Doug Baldwin started this current Seahawks fad of traveling outside the team's normal medical coverage to get far-flung treatment using body cells. The Seahawks' No. 1 wide receiver told me Monday he went overseas before this season ...

and more »

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Why Doug Baldwin went to England for stem-cell therapy - The News Tribune (blog)

Stem Cell Treatment Helps Puppies With Spina Bifida – Technology Networks

By Stem Cell Medicine

A pair of English bulldog puppies are the first patients to be successfully treated with a unique therapy a combination of surgery and stem cells developed at the University of California, Davis, to help preserve lower-limb function in children with spina bifida.

Because dogs with the birth defect frequently have little control of their hindquarters, they also have little hope for a future. They are typically euthanized as puppies.

At their postsurgery re-check at 4 months old, however, the siblings, named Darla and Spanky, showed off their abilities to walk, run and play to their doctor, veterinary neurosurgeon Beverly Sturges.

The initial results of the surgery are promising, as far as hind limb control, said Sturges. Both dogs seemed to have improved range of motion and control of their limbs.

The dogs have since been adopted, and continue to do well at their home in New Mexico.

A major step toward curing spina bifida

Spina bifida occurs when spinal tissue improperly fuses in utero, causing a range of cognitive, mobility, urinary and bowel disabilities in about 1,500 to 2,000 children born in the U.S. each year. The dogs procedure, which involved surgical techniques developed by fetal surgeon Diana Farmer of UC Davis Health together with a cellular treatment developed by stem cell scientists Aijun Wang and Dori Borjesson, director of the universitys Veterinary Institute for Regenerative Cures, represents a major step toward curing spina bifida for both humans and dogs.

Farmer pioneered the use of surgery prior to birth to improve brain development in children with spina bifida. She later showed that prenatal surgery combined with human placenta-derived mesenchymal stromal cells (PMSCs), held in place with a cellular scaffold, helped research lambs born with the disorder walk without noticeable disability.

Sturges wanted to find out if the surgery-plus-stem-cell approach could give dogs closer-to-normal lives along with better chances of survival and adoption. At 10-weeks old, Darla and Spanky were transported from Southern California Bulldog Rescue to the UC Davis veterinary hospital, where they were the first dogs to receive the treatment, this time using canine instead of human PMSCs.

Another distinction for Darla and Spanky is that their treatment occurred after birth, since prenatal diagnosis of spina bifida is not performed on dogs, Sturges explained. The disorder becomes apparent between 1 and 2 weeks of age, when puppies show hind-end weakness, poor muscle tone, incoordination and abnormal use of their tails.

A unique environment for collaborative research

UC Davis is the only place where this type of cross-disciplinary, transformational medicine could happen, according to Farmer.

Its rare to have a combination of excellent medical and veterinary schools and strong commitment to advancing stem cell science at one institution, she said.

UC Davis is also home to the One Health initiative aimed at finding novel treatments like these for diseases that affect both humans and animals.

Ive often said that I have the greatest job on the planet, because I get to help kids, Farmer said. Now my job is even better, because I get to help puppies too.

Hopes for clinical trials in humans and dogs

With additional evaluation and U.S. Food and Drug Administration approval, Farmer and Wang hope to test the therapy in human clinical trials. Sturges and Borjesson hope to do the same with a canine clinical trial. They hope the outcomes of their work help eradicate spina bifida in dogs and humans.

In the meantime, the team wants dog breeders to send more puppies with spina bifida to UC Davis for treatment and refinements that help the researchers fix an additional hallmark of spina bifida incontinence. While Darla and Spanky are very mobile and doing well on their feet, they still require diapers.

Further analysis of their progress will determine if the surgery improves their incontinence conditions, Sturges said.

Funding for this project was provided by the Veterinary Institute for Regenerative Cures (VIRC) at the UC Davis School of Veterinary Medicine, and the Surgical Bioengineering Lab at the UC Davis School of Medicine. Private donations to the veterinary school for stem cell research also contributed to this procedure. Farmer and Wangs spina bifida research is supported by funding from the National Institutes of Health, the California Institute for Regenerative Medicine, Shriners Hospitals for Children and the March of Dimes Foundation.

This article has been republished frommaterialsprovided byUC Davis. Note: material may have been edited for length and content. For further information, please contact the cited source.

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Stem Cell Treatment Helps Puppies With Spina Bifida - Technology Networks

US FDA steps up scrutiny of stem cell therapies – Reuters

By Stem Cell Medicine

(Reuters) - The U.S. Food and Drug Administration (FDA) is stepping up efforts to better regulate an emerging field of medicine that holds significant promise for curing some of the most troubling diseases by using the body's own cells.

A small number of "unscrupulous actors" have seized on the promise of regenerative medicine and stem cell therapies to mislead patients based on unproven, and in some cases, dangerously dubious products, the FDA said on Monday. (bit.ly/2iB4Xls)

Regenerative medicine makes use of human cells or tissues that are engineered or taken from donors. Health regulators have approved some types of stem cell transplants that mainly use blood and skin stem cells after clinical trials found they could treat certain types of cancer and grow skin grafts for burn victims.

But many potential therapies are still in the earliest stages of development. These therapies are sometimes advertised with the promise of a cure, but they often have scant evidence backing their efficacy or safety.

The FDA said it had taken steps to tackle the problem of some "troubling products" being marketed in Florida and California.

Federal officials on Friday seized from San Diego-based StemImmune Inc vials containing hundreds of doses of a vaccine reserved only for people at high risk for smallpox, the FDA said. (bit.ly/2wC1DMU)

The seizure followed recent FDA inspections that confirmed the vaccine was used to create an unapproved stem cell product, which was then given to cancer patients, the agency added.

The FDA also sent a warning letter to a Sunrise, Florida-based clinic for marketing stem cell products without regulatory approval and for major deviations from current good manufacturing practices. (bit.ly/2giGlx9)

The health regulator will present a new policy framework this fall that will more clearly detail the "rules of the road" for regenerative medicine, FDA Commissioner Scott Gottlieb, a cancer survivor, said in a statement.

Reporting by Natalie Grover in Bengaluru; Additional reporting by Tamara Mathias; Editing by Sai Sachin Ravikumar

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US FDA steps up scrutiny of stem cell therapies - Reuters

ICMR’s stem cell research guidelines soon to be released – ETHealthworld.com

By Stem Cell Medicine

Representative imageBy Priyanka V Gupta

New Delhi: Indian Council of Medical Research (ICMR) will soon release the final document on guidelines for stem cell research, the draft of which was available on the ICMR and the DBT (Department of Biotechnology) websites for public reviews till July 31 this year. The guidelines are expected to help in curbing the unethical practices in regenerative medicine. The information was shared by Dr Geeta Jotwani, deputy director general, ICMR, at a recent event where MoU was signed between ABLE (Association of Biotechnology Led Enterprise) and FIRM (Forum for Innovative Regenerative Medicine) for industry research collaborations.

Dr Jotwani said, On the directives of DCGI (Drug Controller General of India), ICMR has been framing the guidelines for stem cell research and therapy since 2001. Unfortunately, there is no therapy available other than bone marrow transplantation, for which also no standard of care has been laid out. In that direction, we have been making periodic efforts by releasing the guideline documents in 2002, 2007, 2013 and now the updated documentation for 2017 is under finalization.

ICMR has been proactively working towards educating the stakeholders about the ethical practices in stem cell research and therapy, for which a special committee, called National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT), has been formed to advise the scientists community. Regenerative medicine is an innovative science. As part of ICMR, more research is involved than getting into conclusion that we are ready for application. We are proactively making efforts to educate, create awareness and give directions to our scientists community and clinicians on how they should go about the research part of stem cell therapy, said Dr Jotwani.

There are many clinicians entering into unethical practices and promising general public about the available care in almost all sorts of incurable conditions, including autism, according to Dr Jotwani.

She said, We are always concerned about what the end users are getting and the promises that are being made to them. Hence, we are proactively being involved in interacting with different government agencies as well as the industry to curb the unethical practices for which we also established NAC-SCRT under the Department of Health Research, Government of India. The committee, which comprises of different government agencies as well as ethics and social groups, legal experts, representatives of drug controllers office and CDSCO (Central Drug Standard Control Organization), deliberates on the issues of upcoming technologies and takes proactive role in the regenerative medicine.

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ICMR's stem cell research guidelines soon to be released - ETHealthworld.com

FDA cracks down on clinics selling unapproved stem cell therapies – CBS News

By Stem Cell Clinics

The U.S. Food and Drug Administration announced a crackdown on stem-cell clinics marketing and selling unapproved and potentially harmful therapies for cancer and other diseases.

The agency took action against two large clinics in Florida and California, which have started selling treatments that the agency says use stem cells but have not been approved as safe and effective by the FDA.

"A small number unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt, assurances to patients based on unproven and, in some cases, dangerously dubious products," FDA Commissioner Scott Gottlieb, M.D., said in a statement.

The FDA issued a warning letterto US Stem Cell Clinic of Sunrise, Florida, after an inspection in which the agency found that the clinic was processing body fat into stem cells and administering the product both intravenously or directly into the spinal cord of patients with Parkinson's disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease and pulmonary fibrosis.

"The FDA has not reviewed or approved any biological products manufactured by US Stem Cell Clinic for any use," the agency said in a statement.

During the inspection, investigators also reported the clinic deviated from guidelines put in place to prevent microbiological contamination, which puts patients at risk for infections, the agency said.

Also this week, the FDA seized five vials of a smallpox vaccinefrom StemImmune Inc. in San Diego, California, which the agency said was used to create an unapproved treatment of stem cells and excess amounts of the vaccine, which was then administered to cancer patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California.

The FDA says this treatment put patients at risk for potential harms including inflammation and swelling of the heart and surrounding tissues.

The agency said it will investigate how StemImmune Inc. obtained the vials of the vaccine, which each contained 100 doses. The vaccine is not commercially available and is reserved only for people considered at high risk for smallpox, such as some members of the military. One vial was partially used, while four of the vials were still intact, the FDA reports.

"I've directed the agency to vigorously investigate these kinds of unscrupulous clinics using the full range of our tools, be it regulatory enforcement or criminal investigations. Our actions today should also be a warning to others who may be doing similar harm, we will take action to ensure Americans are not put at unnecessary risk," Gottlieb said.

In response, Dr. Mark Berman, co-founder of the California Stem Cell Treatment Centers, told the Los Angeles Times that the comments from the FDA are "disparaging and misrepresentative," and said they showed "a lack of understanding" of surgical procedures in which patients' own stem cells are used to promote regeneration.

Berman, who is also director of stem cell implantation at StemImmune, called the clinic's products "cutting edge cancer therapy" for Stage 4 cancer patients, the Times reports.

US Stem Cell Clinicposted a response to its website, saying, "The safety and health of our patients are our number one priority and the strict standards that we have in place follow the laws of the Food and Drug Administration."

"The FDA has stated that they will have specific stem cell guidelines by the 21st Century Cures Act deadline of December 13, 2017 and we intend to follow those standards as well," the statement continues. "We have helped thousands of patients harness their own healing potential. It would be a mistake to limit these therapies from patients who need them when we are adhering to top industry standards."

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FDA cracks down on clinics selling unapproved stem cell therapies - CBS News

FDA cracks on clinics using unapproved stem cell treatments – Pulse Headlines

By Stem Cell Clinics

The U.S. Food and Drug Administration (FDA) said on Monday that it would take severe measures after it found that clinics around the country are selling unapproved and potentially dangerous stem cell treatments to patients with cancer and other hard diseases, according to a warning letter posted by the agency.

The crackdown was announced due to hundreds of clinics around the country selling unapproved stem cell therapies, but two of them were specifically pointed: the U.S. Stem Cell Clinic of Sunrise, Florida; and California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills. In the last one, certain doctors carried out a surgery where they injected a smallpox vaccine intravenously and directly to the patients tumors.

Many of these patients have suffered great harm, and even death as a result of using unproven stem cell therapies, the President of the International Society for Stem Cell Research, Hans Clevers, said in a statement. We are hopeful that increased regulatory enforcement against clinics offering unproven treatments will deter this practice and help protect patients.

On Monday, the FDA posted on its web page a warning letter sent last week to U.S. Stem Cell Clinic of Sunrise, Florida. In it, the agency condemned the selling of unapproved stem cells treatments, which doctors injected intravenously and directly into the patients spines. Previously, according to a report published by the New England Journal of Medicine, this Florida clinic was already linked with three women who ended up blind after they were subjected to a fat-stem cell treatment for macular degeneration.

However, this is just one of many other clinics around the country that the agency accused to use stem cells vaccines to treat different conditions, such as cancer, Parkinsons disease, amyotrophic lateral sclerosis (ALS), and lung and heart diseases.

Along with it, on the same Monday, the agency announced that last week it accused StemImmune Inc. of San Diego to purchase five live virus vaccine vials, previously designated to only those patients who were at high risk of smallpox. At the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, the vaccines were later combined with stem cells extracted from patients fat and injected directly to patients tumors.

Ive directed the FDA to launch a new working group to pursue unscrupulous clinics through whatever legally enforceable means are necessary to protect the public health, The FDA commissioner, Dr. Scott Gottlieb wrote in a statement. We have examples where some of these unproven treatments have clearly harmed patients.

Doctors might offerunapproved stem cells therapies, and people under high-risk diseases might accept them without having a second thought. This is why the FDA published a series of advice for safe before they choose an unproved and dangerous treatment instead of a secure and adequate therapy.

If you see a business thats making all sorts of dramatic marketing claims across disease categories, claiming to use fat as a treatment for all sorts of indications, these are all signs to be wary of, said Leigh Turner, associate professor at the Center for Bioethics at the University of Minnesota.

According to Turner, it is not easy for patients to either recognize which treatment would be good and beneficial for them, or which one would be totally dangerous.

Source: CNN

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FDA cracks on clinics using unapproved stem cell treatments - Pulse Headlines

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