Skip to main content

US Moves to Shut Down 2 Big Stem Cell Therapy Clinics

Image
By
Federal authorities Wednesday moved to shut down two of the country’s most prominent for-profit providers of stem cell therapy, one of them a network of clinics with more than 100 offices in the United States, including several in the Bay Area.

The Food and Drug Administration filed two complaints in federal court requesting permanent injunctions that would stop Florida-based U.S. Stem Cell Clinic and the California Stem Cell Treatment Center from marketing therapies. Both companies have previously been called out by the FDA for providing unproven, unapproved therapies that could put patients at risk.

The injunction requests are an aggressive move by the FDA to patrol the consumer stem cell market. The agency has come under mounting pressure by scientists and patient advocates to increase oversight of the growing consumer market, which has been allowed to flourish for years.


“In the two cases filed today, the clinics and their leadership have continued to disregard the law and more importantly, patient safety,” FDA Commissioner Scott Gottlieb said in a statement. “We cannot allow unproven products that exploit the hope of patients and their loved ones.”

The complaints were filed in U.S. District Court by the U.S. Department of Justice.

The move was a welcome surprise to scientists who have long criticized both the consumer clinics and the FDA’s seeming reluctance to rein them in. The FDA announced new guidelines in November for the consumer stem cell industry, but had issued just one warning letter since then.

“These are two of the biggest, most visible players in the marketplace. They make dramatic and unscientific marketing claims about treating all kinds of conditions,” said Leigh Turner, a scientist with the Center for Bioethics at the University of Minnesota. “This is more than talk by the FDA. This is real action. It’s a major development.”

Both U.S. Stem Cell Clinic and California Treatment Center use a stem cell product that is made from patients’ own fat cells. The fat is collected via liposuction, then treated in a way to separate stem cells and other cellular products before being re-injected into the patient.

Providers at the clinics use the fat-derived product to treat a host of conditions, including multiple sclerosis, Parkinson’s disease and arthritis. The therapies are not covered by insurance and often cost several thousand dollars.

U.S. Stem Cell Clinic was involved in the cases of three women in 2015 who were given stem cell injections in their eyes to treat vision problems and who ended up permanently blind; a fourth woman has come forward with a similar complaint. The clinic and its operators received a warning letter from the FDA in August accusing them of marketing products that were not federally approved and possibly putting patients at risk.

The California Stem Cell Treatment Center also has been targeted by the FDA in the past. It, too, has been involved in a case of a patient claiming to have been blinded by a stem cell treatment.

The FDA complaint filed Wednesday specifically refers to the California Stem Cell Treatment offices in Rancho Mirage (Riverside County) and Beverly Hills, but a spokeswoman for the agency said the injunction may apply to other clinics in the network. The network’s website lists six clinics in the Bay Area.

Mark Berman, co-founder of the California Stem Cell Treatment Center, said Wednesday he was eager to face the FDA in court and resolve what amounts to “a difference of opinion.”

“They want to say that your cells in your body are a drug. Their position is if it’s a drug it needs to be made just like every other mass-produced chemical product. That’s really silly,” Berman said.

He added that his products may not have gone through the rigorous scientific testing that applies to new drugs, but he’s satisfied that his therapies are safe and effective based on patient reports. “We have a lot of wonderful outcomes,” Berman said.

Turner said that kind of boasting is one reason why clinics like Berman’s need to be better regulated. There is no evidence that these stem cell therapies work or that they’re safe, he said.

“The FDA is taking important steps to provide better oversight and try to create a safer marketplace,” Turner said.

Source : https://goo.gl/h7Pok6

Comments

Post a Comment

Popular posts from this blog

Lab-Grown Blood Stem Cells Produced at Last

By
After 20 years of trying, scientists have transformed mature cells into primordial blood cells that regenerate themselves and the components of blood. The work, described today in Nature, offers hope to people with leukaemia and other blood disorders who need bone-marrow transplants but can’t find a compatible donor. If the findings translate into the clinic, these patients could receive lab-grown versions of their own healthy cells. One team, led by stem-cell biologist George Daley of Boston Children’s Hospital in Massachusetts, created human cells that act like blood stem cells, although they are not identical to those found in nature. A second team, led by stem-cell biologist Shahin Rafii of Weill Cornell Medical College in New York City, turned mature cells from mice into fully fledged blood stem cells. “For many years, people have figured out parts of this recipe, but they’ve never quite gotten there,” says Mick Bhatia, a stem-cell researcher at McMaster University i...
Post a Comment
Read more

Mesentery: New organ discovered inside human body by scientists

By
A new organ has been discovered hiding in plain sight inside the  human body . Known as the mesentery, it was previously thought to be just a few fragmented structures in the digestive system. But scientists have realised it is in fact one, continuous organ.  Although its function is still unclear, the discovery opens up “a whole new area of science,” according to J Calvin Coffey, a researcher at the  University Hospital Limerick  who first discovered it.  "When we approach it like every other organ… we can categorise abdominal disease in terms of this organ," he said.   “Now we have established anatomy and the structure. The next step is the function. If you understand the function you can identify abnormal function, and then you have disease.  “Put them all together and you have the field of mesenteric science.” The research has been published in  The Lancet   medical journa...
Post a Comment
Read more

Your Guide to Stem Cell Therapy

By
  Stem cells are quite a boon for the mankind’s welfare. Surely many of you may have come across the benefits and challenges in stem cell therapy ; while some may not. I know many thousands of people are curious to know more about this transforming therapy and likewise they look on to google, the internet basically. I’ll try my best in delivering what’s needed – factual and trustworthy information. Please note that I am not trying to sell you anything nor am I a physician. Trained physicians and doctors are the best sources to get medical advice from. Always consult them because it’s better to be safe than sorry. While we get into it, your support is very much appreciated and we are delighted to help you anytime. Stem cells are cells found in our body just like other cells; what sets them apart is their ability of regenerate and differentiation. Regeneration is the ability of the cell to renew itself after cell division or injury. The later is the ability to specialize in a gener...
Post a Comment
Read more