A federal court has once again ruled against a stem cell clinic, siding with the FDA that fat-derived stem cell treatments are a "drug" and should be regulated as such.
The 9th Circuit Court of Appeals determined that stromal vascular fraction (SVF) -- a mixture of stem cells, other cells, and cell debris spun down from patients' own fat cells -- is a drug, and is not exempt under FDA's "same surgical procedure" exception.
"SVF is now definitively a drug. The FDA can regulate them as a drug throughout the U.S.," Paul Knoepfler, PhD, a stem cell expert at the University of California Davis, wrote on his blog. "This is important for several reasons. In Florida and another state, some patients who received SVF lost their vision. There have been other side effects as well."
Back in 2018, FDA sued the California Stem Cell Treatment Center and the related Cell Surgical Network over its SVF treatments. In 2022, a federal judge in California ruled in favor of the center, agreeing that those treatments weren't subject to regulation. But the FDA appealed and won this most recent case.
This outcome is similar to that seen in another lawsuit brought by the FDA against Florida-based U.S. Stem Cell Clinic over its SVF treatments. The clinic lost its case in 2019 and its appeal was subsequently denied.
Knoepfler called it "the biggest FDA stem cell news in a few years," as there are now two federal court precedents that SVF constitutes a drug.
He also noted that a third case, U.S. v. Regenerative Sciences, determined that another type of stem cell therapy in which mesenchymal stem cells from bone marrow are subsequently cultured and mixed with an antibiotic before being injected back into patients was also a drug.
"Many have wondered whether this lengthy case and the uncertainty it brought had led the FDA to be more cautious in taking action in the stem cell clinic arena," Knoepfler wrote on his blog. "The main uncertainty now is whether this case could be appealed to the Supreme Court. In the meantime, will the agency be bolder in actions related to unproven cell therapy clinics? I hope so."
The California Stem Cell Treatment Center case was unusual in that one of its founders, Mark Berman, MD, died in April 2022 from causes related to a COVID-19 infection he had contracted that previous January. He had co-founded the center in 2010 and went on to create the Cell Surgical Network, which he ran with partner Elliot Lander, MD.
The center has two clinics, in Beverly Hills and Rancho Mirage. As noted in the federal court decision, the clinics provide "patient-funded investigational research"; they don't take any insurance coverage and patients pay out of pocket. A typical treatment costs $8,900, while a 12-treatment option costs $41,500.
The clinics treat a wide range of conditions, including "Alzheimer's, arthritis, asthma, cancer, macular degeneration, multiple sclerosis, heart problems, pulmonary problems, Crohn's, Parkinson's, and erectile dysfunction," according to the court decision.
Its Cell Surgical Network includes other doctors who follow its treatment protocols and pricing. Those doctors also purchase equipment for isolating cells -- known as the "Time Machine" -- from the company, which costs about $30,000.
Though FDA now appears to have more authority over clinics offering SVF, Knoepfler said it's "possible the clinic industry will pivot and focus more on other cells."
"For instance, we could see adipose cell clinics begin marketing birth-related cell preparations," Knoepfler wrote. "However, the FDA has been very consistent that those therapies are also drugs and I think they are on even firmer legal ground there."
He cautioned, however, that there hasn't been a court precedent against stem cells derived from bone marrow, "which in an unmodified form does not appear to constitute a drug."
https://www.medpagetoday.com/special-reports/exclusives/112228
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