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The Food and Drug Administration has won a federal judge's backing for its efforts to crack down on the rapidly growing stem cell industry that promises all kinds of unproven treatments for serious diseases.
On Monday, the federal judge ruled that the FDA has the authority to regulate treatments provided by U.S. Stem Cell Clinic and U.S. Stem Inc., which claim stem cells derived from a patient's own fat cells can treat conditions ranging from Parkinson’s disease to pulmonary fibrosis.
The FDA first took legal action against the Florida-based clinics in May 2018, seeking an injunction to stop them from providing their treatments. The legal action came after several attempts by the FDA to provide the clinics the opportunity to work with the agency to come into compliance with regulations and protect patients from harm.
Such stem cell treatments have not been proven to be safe or effective, acting FDA Commissioner Dr. Ned Sharpless said in a statement.
What’s more, the clinics put patients at risk for infection by failing to prevent the contamination of their products, the FDA said.
In 2017, doctors reported in the New England Journal of Medicine that the three elderly women lost their vision after being treated at U.S. Stem Cell. The women, who had vision loss from age-related macular degeneration, received eye injections containing their own fat and blood cells. Rather than seeing an improvement in their condition, all three women showed up at eye hospitals days later with retinas detaching, rapidly worsening vision and hemorrhaging. All of the women lost most of their vision as a result.
“In the case against U.S. Stem Cell Clinic, the clinic and its leadership have put patients at serious risk through their disregard of the law and prior FDA warnings,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement. “We are committed to pursue actions against those who put patients in harm’s way by marketing unapproved stem cell products that skirt FDA’s regulation and federal law.”
In a separate legal action, the FDA is also seeking injunctions against several stem cell clinics in California.
Stem cells are very young cells that can develop into specialized cells, such as blood cells, bone cells and brain cells. The cells are being studied as a potential way to treat many diseases and are currently approved by the FDA for a handful of medical procedures, such as using bone marrow or blood stem cells to treat patients with blood or immune system cancers or disorders.
However, a 2016 study found hundreds of clinics across the U.S. offering bogus stem cell treatments.
“Cell-based regenerative medicine holds significant medical opportunity,” Sharpless said. “We support sound, scientific research and regulation of cell-based generative medicine.”
Outside of that framework, however, the FDA has a warning: “Don’t believe the hype.”