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.