A court ruling Friday will open the door to the FDA more tightly regulating stem cell clinics and a commonly-used stem cell mixture known as stromal vascular fraction (SVF) treatments.
The ruling, made by the US Court of Appeals for the Ninth Circuit, overturned a lower California court’s decision after a chain of stem cell clinics known as the California Stem Cell Treatment Center and the Cell Surgical Network won a 2022 court battle to keep their SVF completely exempt from FDA regulation.
The clinics won the lower court ruling through an exception for certain surgical procedures where human cells or tissue products are removed from patients and implanted back into them during the same procedure.
But the appeals court ruled that this exception only applies to a procedure if the removed cell or tissue products and the implanted ones are the same. In this case, the appeals court ruled, the procedure removes fat tissue, not the cells targeted for implantation, and implants SVF, meaning they are “not exempt from regulation.”
One of the judges concurring with the appeals court ruling found this exception in the law to be “genuinely ambiguous,” but said the court should defer to the FDA’s “reasonable interpretation” of the exception.
Looking ahead, Paul Knoepfler, professor at UC Davis School of Medicine who conducts research on stem cells and cancer, wrote on his blog that “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 case is also similar to one in Florida that the FDA won in 2019 against stem cell clinics.
The FDA didn’t immediately respond to a request for comment.