The US Food and Drug Administration (FDA) has filed two complaints in federal in court, in which it is seeking permanent injunctions against two stem cell clinics to prevent them from marketing stem cell products without FDA approval and for significant deviations from current GMP practice requirements.
Legal outcome
“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. In the two cases filed today, the clinics and their leadership have continued to disregard the law and more importantly, patient safety. We cannot allow unproven products that exploit the hope of patients and their loved ones,” said FDA commissioner Dr Scott Gottlieb. “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.”
Of the two companies in question, the FDA is seeking a permanent injunction against US Stem Cell Clinic of Sunrise, Florida, 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 and while violating current good manufacturing practice requirements, including some that could impact the sterility of their products, putting patients at risk. Additionally, the FDA is seeking a permanent injunction to stop California Stem Cell Treatment Center, with locations in Rancho Mirage and Beverly Hills, California; Cell Surgical Network Corporation of Rancho Mirage, California; and Dr Elliot B. Lander, and Dr Mark Berman, from marketing to patients stem cell products without FDA approval.
More information on these actions can be found on the agency’s website