Judge Rules in Favor of Stem Cell Clinic

A federal judge has declined to block a California stem cell clinic from continuing to perform what the FDA has called unproven treatments, delivering a potential setback to the agency.

U.S. District Court Judge Jesus Bernal ruled in favor of the California Stem Cell Treatment Center last week, accepting the clinic's position that its stem cell procedures are not subject to FDA regulation.

Bernal ruled that the "[d]efendants are engaged in the practice of medicine, not the manufacture of pharmaceuticals."

The FDA brought the lawsuit against the California company in May 2018, at the same time it brought a similar suit against a Florida stem cell clinic as part of a larger effort to crack down on unproven and potentially dangerous stem cell therapies.

Unlike the California clinic, the Florida clinic -- U.S. Stem Cell Clinic, founded by Kristin Comella, PhD -- lost its case in 2019 and its appeal was subsequently denied.

Bernal's ruling follows a 7-day trial in May 2021, for which closing arguments wrapped up more than a year ago, in August 2021.

And Mark Berman, MD, a co-founder of the California clinic, died in April, though his death didn't come to light for weeks thereafter, with an obituary only appearing in June. The Los Angeles Times reported in May that his death was related to COVID-19, which he'd contracted in January.

In addition to the California center, and prior to his death, Berman ran a national chain of stem cell clinics -- the Cell Surgical Network -- with his partner Elliot Lander, MD.

Critics have raised concerns about the California ruling, charging that it could allow such clinics to proliferate and that it poses a challenge to FDA regulation of these therapies, which the agency has long been attempting to curb.

"Strikingly, Bernal sided with the defendants in almost every way," Paul Knoepfler, PhD, a stem cell expert at the University of California Davis, wrote on his well-known stem cell blog. "To me, the language of his ruling sounded almost like it was written by the defendants."

He said it was "aggravating as a scientist to see a court get the science so wrong."

At the heart of the California and Florida lawsuits is a product called stromal vascular fraction (SVF), which is made by taking a patient's own fat cells and spinning them down to concentrate this purported mixture of stem cells.

Knoepfler said that in the Florida case and another case -- U.S. v. Regenerative Sciences -- the court ruled that this concentrated mixture was indeed a drug.

"It's important to point out that Bernal's ruling here goes against some very important precedent," Knoepfler wrote.

"I'm not aware of good evidence that growing adipose cells in a lab leaves all of their properties unchanged," he added. "To the contrary, there is compelling evidence that cell properties can change substantially when they are cultured in the lab. The cells can also be contaminated in labs."

The FDA can appeal the decision, but the agency said in a statement to MedPage Today that it is "reviewing the court's decision and does not have further comment at this time."

The agency's crackdown on unproven stem cell products has been in the works for a long time, with its long-awaited regenerative medicine guidelines going into effect in May 2021 after a 3.5-year compliance period. Knoepfler previously noted that the FDA has done "surprisingly little" on stem cell clinics since the regulations took effect -- though it did issue warning letters to birth tissue companies earlier this summer.

"There has been a sense that the FDA may have been holding back on large-scale actions on the hundreds of SVF clinics operating in the U.S. until this Bernal ruling came down," Knoepfler wrote in his most recent blog post. "The new judgment in favor of SVF clinics could make FDA even more cautious on taking action on unproven clinics more generally. At the same time, some clinics are more likely to be emboldened by Bernal's ruling."

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