A recent appeals court decision opens the door for the federal Food and Drug Administration to regulate a procedure offered at several California stem cell clinics that critics say is unproven and potentially harmful.
The Ninth Circuit Court of Appeals on Sept. 27 rejected arguments by defendant doctors and California stem cell clinics that a cell therapy should not be regulated as a drug by the FDA. The federal government sued the California Stem Cell Treatment Center, Cell Surgical Network Corp. and two medical doctors in the Central District of California, arguing that the defendants were violating the Food, Drug and Cosmetic Act through improper manufacture and labeling of the mixture, called stromal vascular fraction (SVF).
Although the district court sided with the defendants, the Ninth Circuit found that SVF constituted a drug that could be regulated by the FDA.
“Defendants argue that their SVF is not a ‘drug’ within the meaning of the (Food, Drug and Cosmetic) Act and that, even if it is, some of their uses of SVF fall under an exception from FDA regulation for certain surgical procedures,” the appeals court decision states. “We reject both arguments. Accordingly, we reverse the district court’s entry of judgment in favor of defendants.”
The defendant doctors create SVF from a patient’s fat cells by liquifying the cells and breaking them down so that a portion of the resulting mixture contains stem cells, according to the opinion. The substance can then be reinjected back into the patient to treat a number of maladies.
“Defendants advertise that they have ‘technology to produce a solution rich with your own stem cells’ that they say can alleviate dozens of medical conditions, including Alzheimer’s, arthritis, asthma, cancer, macular degeneration, multiple sclerosis, heart problems, pulmonary problems, Crohn’s, Parkinson’s and erectile dysfunction,” the appeals court decision says.
One treatment usually costs about $8.900, according to the Ninth Circuit.
The stem cell clinics argued that the SVF treatment, which can be completed during a single day, would be exempt from FDA regulation even if it were considered a drug. That’s because a section of federal law states that human cells, tissues and cellular and tissue-based products (HCT/P) that are removed from an individual and then implanted in the same person receive a ”same surgical procedure” SSP exemption.
But the Ninth Circuit concluded that the fat cells removed during the SVF procedure are not the same as the mixture implanted in the patient. In turn, the exemption does not apply, the decision states.
Some critics of the science embraced by the stem cell clinics expressed satisfaction with the appeals court ruling.
“I see the appeals court ruling as a positive development,” professor Paul Knoepfler of the University of California, Davis, School of Medicine, said in an email to the Southern California Record. “It rightly clarifies that the FDA has the authority to regulate SVF as a drug. This cell mixture does not naturally occur in the body but rather is a lab-creation made through multiple processing steps.”
Knoepfler stressed that SVF has not been proved safe and effective for specific medical conditions.
“This is not just a hypothetical concern,” he said. “The marketing of SVF without FDA approval throughout the U.S. has in past years also led to harm including people losing their vision.”