FDA seeks permanent injunctions against two stem cell clinics

The U.S. Food and Drug Administration, in two complaints filed in federal court, is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements.

“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 Scott Gottlieb, M.D. “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.”

A permanent injunction is being sought against US Stem Cell Clinic LLC 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. The FDA is taking this action because US Stem Cell Clinic did not address the violations outlined in a warning letter to the clinic and failed to come into compliance with the law. The FDA is seeking an order of permanent injunction requiring 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 violations of current good manufacturing practice requirements.

The FDA is also seeking a permanent injunction to stop California Stem Cell Treatment Center Inc., with locations in Rancho Mirage and Beverly Hills, California; Cell Surgical Network Corporation of Rancho Mirage, California; and Elliot B. Lander, M.D. and Mark Berman, M.D., from marketing to patients stem cell products without FDA approval. Berman and Lander control the operations of approximately 100 for-profit affiliate clinics, including the California Stem Cell Treatment Center. The FDA is seeking an order of permanent injunction requiring California Stem Cell Treatment Center Inc. and Cell Surgical Network Corporation and the individual defendants to cease marketing their stem cell products until, among other things, they obtain necessary FDA approvals and correct their violations of current good manufacturing practice requirements.

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