FDA Continues Crack Down on Unapproved Stem Cell Clinics

Megan Brooks

May 10, 2018

The US Food and Drug Administration (FDA) is seeking permanent injunctions to stop two US stem cell clinics from marketing stem cell products without the agency's approval and for "significant deviations" from current good manufacturing requirements.

The actions against the clinics, which are based in Florida and California, are part of a comprehensive approach to the oversight of regenerative medicinal products, the FDA said.

"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," FDA Commissioner Scott Gottlieb, MD, said in a statement.

Some patients have suffered "serious and permanent harm" after receiving these unapproved products, he noted. In relation to the two cases filed May 9, "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," Gottlieb said.

Putting Patients at Risk

The FDA is seeking a permanent injunction 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 unapproved stem cell products and violating current good manufacturing practice requirements that could affect the sterility of their products, putting patients at risk, the FDA said.

The FDA filed the injunction after US Stem Cell Clinic failed to respond to an FDA warning letter issued in August 2017, as reported by Medscape Medical News.

The warning letter cited an FDA inspection that found that the clinic was processing adipose tissue into stromal vascular fraction and administering the product either intravenously or directly into the spinal cord of patients to treat a variety of conditions, including Parkinson's disease, amyotrophic lateral sclerosis, chronic obstructive pulmonary disease, heart disease, and pulmonary fibrosis. The FDA has not reviewed or approved any biological products manufactured by US Stem Cell Clinic for any use.

The FDA is also seeking a permanent injunction to stop California Stem Cell Treatment Center Inc, which is located in Rancho Mirage and Beverly Hills; Cell Surgical Network Corporation, of Rancho Mirage; and Elliot B. Lander, MD, and Mark Berman, MD, from marketing unapproved stem cell products. Berman and Lander run operations of roughly 100 for-profit affiliate clinics, including the California Stem Cell Treatment Center.

Last August, the FDA took action to prevent the use of a "potentially dangerous and unproven" treatment belonging to StemImmune Inc of San Diego, California, which was given to patients at the California Stem Cell Treatment Centers.

On behalf of the FDA, the US Marshals Service seized five vials of vaccinia virus vaccine (live), which is reserved for people at high risk for smallpox, such as some members of the military. Each of the vials originally contained 100 doses of the vaccine. Although one vial was partially used, four of the vials were intact, the FDA said.

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). The unproven and potentially dangerous treatment was being injected intravenously or directly into patients' tumors.

The FDA said California Stem Cell Treatment Center products are also being used for the experimental treatment of patients with arthritis, stroke, amyotrophic lateral sclerosis, multiple sclerosis, macular degeneration, Parkinson's disease, chronic obstructive pulmonary disease, and diabetes.

The FDA has not approved any biological products manufactured by California Stem Cell Treatment Center for any use.

Gottlieb said the FDA supports "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."

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