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The agency is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval and for violating cGMP requirements.
On May 9, 2018, FDA filed two complaints in federal court seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval, as well as for violating current good manufacturing practice (cGMP) requirements.
The agency is seeking a permanent injunction against US Stem Cell Clinic, its chief scientific officer Kristin Comella, and its co-owner and managing officer Theodore Gradel for marketing to patients stem cell products without FDA approval as well as violating cGMPs, including some that could impact the sterility of their products.
FDA states that it is taking action because the Sunrise, FL-based clinic did not address the violations outlined in an August 2017 warning letter to the clinic and failed to come into compliance with the law. The warning letter cited an FDA inspection of the clinic which found that it was processing adipose tissue (body fat) into stromal vascular fraction (a cellular product derived from body fat) and administering the product both intravenously or directly into the spinal cord of patients to treat a variety of serious diseases or conditions, including Parkinson’s disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease, and pulmonary fibrosis. FDA has not approved any biological products manufactured by US Stem Cell Clinic for any use.
The permanent injunction would require US Stem Cell and the individual defendants to cease marketing their stem cell products until, among other things, they obtain necessary FDA approvals and correct their cGMP violations, as stated by the agency.
According to the agency, during the inspection of US Stem Cell Clinic in April and May 2017, FDA investigators also documented evidence of significant deviations from cGMPs in the manufacture of at least 256 lots of stem cell products by the clinic. For example, the clinic was cited for its failure 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.
FDA is also seeking a permanent injunction to stop California Stem Cell Treatment Center, Elliot B. Lander, MD, and Mark Berman, MD, from marketing stem cell products to patients without FDA approval. Berman and Lander control the operations of approximately 100 for-profit affiliate clinics, including the California Stem Cell Treatment Center, with locations in Rancho Mirage and Beverly Hills, CA; Cell Surgical Network of Rancho Mirage, CA. The agency is seeking an order of permanent injunction requiring California Stem Cell Treatment Center and Cell Surgical Network and the individual defendants to cease marketing their stem cell products until they obtain necessary FDA approvals and correct cGMP violations, according to the agency.
In August 2017, FDA took action to prevent the use of a treatment by StemImmune in San Diego, CA and the administration of the treatment to patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, CA. On behalf of FDA, the United States Marshals Service seized five vials of Vaccinia Virus Vaccine (Live), a vaccine that is reserved only for people at high risk for smallpox, such as some members of the US 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 (a combination of excess amounts of vaccine and stromal vascular fraction-a cellular product derived from body fat). 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 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 a variety of serious diseases or conditions, including cancer, arthritis, stroke, ALS, multiple sclerosis, macular degeneration, Parkinson’s disease, COPD, and diabetes. FDA states that it has not approved any biological products manufactured by California Stem Cell Treatment Center for any use.
During inspections of California Stem Cell Treatment Center’s Beverly Hills and Rancho Mirage facilities in July 2017, FDA investigators documented evidence of significant deviations from cGMP requirements, among other violations. 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.
“We support sound, scientific research and regulation of cell-based regenerative medicine, and FDA has advanced a comprehensive policy framework to promote the approval of regenerative medicine products,” said FDA Commissioner Scott Gottlieb, MD, in an agency press release. “But at the same time, 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.”