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US FDA sues 2 stem cell clinics for selling unapproved products

The U.S. Food and Drug Administration, through the U.S. Department of Justice, filed lawsuits against two stem cell clinics to stop them from selling unapproved stem cell products and violating current good manufacturing practice regulations.

The first complaint was filed in the U.S. District Court of Southern District of Florida against U.S. Stem Cell Inc.'s US Stem Cell Clinic LLC of Sunrise, Fla., Chief Scientific Officer Kristin Comella and Co-Owner and Managing Officer Theodore Gradel. Meanwhile, the second complaint against California Stem Cell Treatment Center Inc., Cell Surgical Network Corp., Elliot B. Lander and Mark Berman was filed in the U.S. District Court for the Central District of California.

According to the regulator, it is seeking a permanent injunction against the stem cell clinics relating to the sale of stem cell products until they receive the necessary FDA approvals and comply with current good manufacturing practice rules.

In August 2017, U.S. Stem Cell Clinic received a warning letter from the FDA over the same concerns, adding that an inspection found the clinic of failing to establish and follow applicable written procedures to prevent microbiological contamination of products.

Also in August 2017, the U.S. Marshals Service, on behalf of the FDA, confiscated five vials of the Vaccinia virus vaccine, a vaccine approved for use in people with high risk of smallpox, from California Stem Cell Treatment Centers. Inspections discovered that the vaccine was used by the company to make an unapproved stem cell product, which was then injected directly and indirectly to cancer patients' tumors.

Stem cell therapies use stem cells, or cells that develop into blood, brain, bones and all of the body's organs, to treat or prevent diseases or conditions, especially those with few existing treatments.

The FDA previously issued a warning about illegal and potentially harmful stem cell therapy procedures, citing instances where a patient became blind after receiving an injection of stem cells into the eye and another where a spinal cord injection resulted to the growth of a spinal tumor.

"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," FDA Commissioner Scott Gottlieb said.

U.S. Stem Cell Clinic has released a statement addressing the matter, announcing its plans to "vigorously defend" the company against the lawsuit.