FDA is cracking down on stem cell clinics that market unapproved products and don't meet good manufacturing practice requirements. On behalf of the agency, the Department of Justice filed two complaints in federal court this week seeking permanent injunctions against a Florida-based clinic and a California-based clinic.
“Cell-based regenerative medicine holds significant medical opportunity, but we’ve also seen some bad actors leverage the scientific promise of this field to peddle unapproved treatments that put patients’ health at risk. In some instances, patients have suffered serious and permanent harm after receiving these unapproved products," said FDA Commissioner Scott Gottlieb, MD.
The agency said Sunrise, FL-based US Stem Cell Clinic ignored the violations outlined in an August 2017 warning letter and failed to come into compliance with the law, continuing to sell unapproved stem cell products. FDA also said US Stem Cell Clinic was found to be in violation of current good manufacturing practice requirements, including some that could impact the sterility of their products and put patients at risk.
FDA also filed for a permanent injunction against Rancho Mirage, CA-based California Stem Cell Treatment Center, which also has a Beverly Hills location, and Rancho Mirage, CA-based Cell Surgical Network Corp., along with Elliot Lander, MD, and Mark Berman, MD. According to the agency's complaint, Berman and Lander control the operations of roughly 100 for-profit affiliate clinics, including the California Stem Cell Treatment Center.
"We cannot allow unproven products that exploit the hope of patients and their loved ones," Gottlieb said. "We support sound, scientific research and regulation of cell-based regenerative medicine, and the FDA has advanced a comprehensive policy framework to promote the approval of regenerative medicine products. But at the same time, the FDA will continue to take enforcement actions against clinics that abuse the trust of patients and endanger their health with inadequate manufacturing conditions or by purporting to have treatments that are being manufactured and used in ways that make them drugs under the existing law but have not been proven safe or effective for any use.”
During an FDA inspection of US Stem Cell Clinic in 2017, investigators found that the clinic was processing body fat into a cellular product derived from body fat and administering that product both intravenously or directly into the spinal cord of patients to treat a variety of diseases and conditions, including Parkinson's disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease, and pulmonary fibrosis. The agency said it has not approved any of the clinic's biological products for any use.
"Investigators also documented evidence of significant deviations from current good manufacturing practices in the manufacture of at least 256 lots of stem cell products by the clinic," FDA noted.
FDA also noted action it took in August 2017 to prevent the use of a potentially dangerous and unproven treatment belonging to San Diego, CA-based StemImmune and administered at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills. On behalf of the agency, U.S. marshals seized five vials of Vaccinia Virus Vaccine (Live), a vaccine that is reserved only for people at high risk for smallpox, such as certain members of the U.S. military.
The seizure came after FDA inspections at StemImmune and the California Stem Cell Treatment Centers confirmed that the vaccine was used to create an unapproved stem cell product. The product was then administered to cancer patients with potentially compromised immune systems and for whom the vaccine posed a potential for harm, including the possibility of inflammation and swelling of the heart and surrounding tissues. The unproven and potentially dangerous treatment was being injected intravenously and directly into patients’ tumors.
California Stem Cell Treatment Center products are also being used for the experimental treatment of patients who suffer from cancer, arthritis, stroke, ALS, multiple sclerosis, macular degeneration, Parkinson’s disease, COPD, and diabetes. The FDA said it has not approved any biological products manufactured by California Stem Cell Treatment Center for any use. During inspections of both of California Stem Cell Treatment Center's facilities in July 2017, FDA investigators also cited the clinics for several manufacturing violations.
During inspections of California Stem Cell Treatment Center’s Beverly Hills and Rancho Mirage facilities in July 2017, FDA investigators documented, among other violations, evidence of significant deviations from current good manufacturing practice requirements. For example, the clinics were cited for failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of products purporting to be sterile, which puts patients at risk for infections.
According to FDA, these cases support the policy framework for the development and oversight of regenerative medicine products, including new cellular therapies. The agency issued four guidance documents in November 2017, two final and two that are still in draft form, that are intended to build upon its existing risk-based regulatory approach. One of the two draft guidance documents laid out a new clinical development model by which promising cell-based products could pursue FDA review and approval.