The Justice Department filed litigation Wednesday to stop two companies from offering stem cell treatments, accusing the businesses of marketing their products without FDA approval and without proof of safety and efficacy.
One compliant was filed against U.S. Stem Cell Clinic of Sunrise, Florida, and its officers Kristin Comella and Theodore Gradel. A separate complaint was filed against Stem Cell Treatment Center of Rancho Mirage and Beverly Hills California, and its owners, Elliot Lander and Mark Berman.
According to court documents, the respective defendants offer the products for a host of disease treatments, including cancer, pulmonary disease, arthritis, stroke, ALS and multiple sclerosis. The California complaint also alleges that Stem Cell Treatment Center claimed they could treat Parkinson’s disease, spinal cord injuries, stroke, pulmonary disease and traumatic brain injury.
“Marketing unproven and potentially unsafe treatments puts consumers at risk,” said acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division. “The Department of Justice will continue to work with the FDA to make sure manufacturers of experimental therapies conduct their research within the safe and legal bounds for drug innovation.”
The Justice Department accused the defendants of using their products without obtaining FDA approval and in some cases harming patients. A recent FDA inspection found the defendants’ products were not manufactured, processed, packed in compliance with good manufacturing practice, according to the complaint.
Earlier this year, an Orlando Sentinel investigation revealed three women suffered injuries at U.S. Stem Cell after seeking treatment for vision loss caused by macular degeneration. The treatments, which cost each woman $5,000 involved harvesting stem cells from their body fat and injecting them into their eyes, according to the article. After the treatment, the women reported eye injuries including detached retinas and optic nerve damage, the Sun Sentinel article said.
It was also revealed in the article that at least one of the women thought she was taking part in a government sanctioned study because U.S. Stem Cell promoted the treatment on ClinicalTrials.gov, which is administered by the National Institutes of Health. That prompted Sen. Charles Grassley, Iowa Republican, to demand the FDA explain how U.S. Stem Cell was listed on the site.
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