In summary
Some stem cell clinics market treatments that have been tested and approved by the FDA. A new court ruling emphasizes that the federal government can regulate the services.
Stem cell clinics have popped up throughout California, promising cures and relief for arthritis, Alzheimer’s and other conditions through cutting-edge technologies. Some, however, are offering services that have not been approved by federal health regulators.
The U.S. Food and Drug Administration last week gained a significant court win against stem cell clinics that promote and administer unproven therapies.
A three-judge panel on the 9th U.S. Circuit Court of Appeals ruled that the FDA can regulate two affiliated Southern California stem cell clinics and their treatments after a lower court had exempted them from regulation.
The decision, experts say, reasserts the FDA’s authority over regenerative medicine at a time when clinics advertising these types of stem cell products are booming. Unproven therapies have led to infections, disabilities and even death, according to adverse reaction reports.
The case dates to 2018, when the FDA sued the California Stem Cell Treatment Center Inc., which has clinics in Rancho Mirage and Beverly Hills, for “improperly manufacturing and labeling” an unapproved product.
The FDA sought to stop the clinics from administering a so-called therapy that takes fat tissue from a patient to create a mixture of cells known as stromal vascular fraction. This is then injected back into the patient to treat a problem area, such as the knee for osteoarthritis.
“In recent years, clinics offering similar stem cell mixtures have proliferated despite concerns over whether such treatments are safe and effective,” one of the 9th Circuit judges wrote.
As stated in the appeals court ruling, the clinics advertised technology that could alleviate dozens of medical conditions, including arthritis, multiple sclerosis, Parkinson’s and heart problems, among others.
Because these treatments are not covered by insurance, people seeking these products pay tens of thousands of dollars out of pocket. A 12-treatment option could cost $41,500, the decision documents show.
The stem cell clinics countered that the treatment should be exempt from FDA oversight because it was more like a surgery than a new drug. In 2022, a federal judge ruled in favor of the clinics and the FDA appealed.
Experts say this most recent ruling strengthens the FDA’s authority over stem cell therapies and will help keep patients safe. It also matches the outcome of an earlier case where the FDA sued a Florida stem cell clinic for administering a similar product and won, barring the clinic from selling such treatment.
“Now there is a coherent federal legal picture that this product can be regulated by the FDA as a drug. As a result, these cells cannot legally be used on patients by stem cell clinics without working with the agency first,” Paul Knoepfler, a professor of cell biology and human anatomy at the University of California, Davis, said via email. “Hundreds of clinics had been marketing them around the U.S. without FDA permission.”
An FDA spokesperson declined to comment on the ruling, saying the agency does not comment on ongoing litigation. Attorneys for the clinics did not return requests for comment.
The landscape of stem cell therapies
The FDA has issued multiple public warnings about stem cell treatments because of their popularity. In its notices, the FDA writes that the only treatments approved for consumers consist of blood-forming stem cells, which are used to fight certain cancers or blood disorders. The list of therapies ready for commercial use is short, experts say. Other types of stem cell treatments have been approved for clinical trials only.
Every drug and therapy approved in the U.S. has to first go through a rigorous and lengthy process that includes a clinical trial to prove it is both safe and effective.
“Please know that if you are being charged for these products or offered these products outside of a clinical trial, you are likely being deceived and offered a product illegally,” the FDA wrote in a warning to consumers in 2021.
Unapproved stem cell products are not only illegal but also dangerous. In a high profile case, three elderly women went blind after receiving an unproven fat tissue-based stem cell treatment for macular degeneration at a Florida clinic, the same one that was later sued by the FDA. According to news reports from when the case was first made public, the women sought treatments because they had difficulty reading fine print. After the procedures, the women suffered detached retinas, vision loss and bleeding inside the eye.
‘You see them on billboards’
The California Institute for Regenerative Medicine, the multi-billion dollar agency voters authorized in 2004 to fund stem cell research, also warns on its website against companies that promote “bogus therapies.”
“The general public knows that stem cells are a very important field that continues to develop, and they believe, as we certainly do, that they’re going to be the source of therapies and cures. The problem is these companies make it sound like we’re there already, and that’s just not the case,” said Jonathan Thomas, president of the agency.
Thomas said last week’s ruling is important because not only does it send a message to clinics that they can’t provide treatments without regulation, but it also gives a nod to researchers who are doing legitimate stem cell work and following the rules.
It’s also a warning for consumers, he said.
It is difficult to track these clinics advertising unapproved cures, so it is unclear how many are operating today. “We just know that they are proliferating because you see signs for them…you see them on billboards, you see ads, you see all sorts of things,” Thomas told CalMatters.
People who are considering a stem cell treatment should ask if the therapy has been approved by the FDA. Thomas said the public should be wary if a stem cell clinic says they are exempt from federal regulation. “Anytime you hear anything like that, I would say that’s a huge red flag,” he said.
Supported by the California Health Care Foundation (CHCF), which works to ensure that people have access to the care they need, when they need it, at a price they can afford. Visit www.chcf.org to learn more.