FDA wins in court against stem cell company


June 4, 2019 at 8:50 a.m. PDT   In a decision expected to send a chill through the booming stem cell industry, a federal judge ruled in favor of the Food and Drug Administration on Monday in a lawsuit against a Florida-based stem cell company whose treatments have blinded at least four patients.   Judge Ursula Ungaro agreed that the FDA has the authority to regulate a procedure that has become widespread in the burgeoning industry — using patients’ fat to create a stem cell treatment.  The judge ruled that the FDA is entitled to an injunction ordering U.S. Stem Cell to halt the procedure……………. read more

The US Food and Drug Administration (FDA) has authority to regulate regenerative medicine products, including stem cell products and exosome products. There is a lot of misleading information on the internet about these products, including statements about the conditions they can be used to treat. FDA is concerned that many patients seeking cures and remedies may be misled by information about products that are illegally marketed, have not been shown to be safe or effective, and, in some cases, may have significant safety issues that put patients at risk. FDA wants to help consumers be informed about how these products are regulated, and what to look for when considering treatment with one of these products.

I get a lot of inquiries about stem cells and the growth of new hair follicles arising out of stem cells.  These two articles addresses the problem and challenges in this field. Stem cells have yet to be approved by the FDA for hair loss treatment.

Get a virtual consultation with Dr. William Rassman and Dr. Jae Pak for hair loss options. You can learn more by scheduling an appointment.

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