Will the FDA block stem cell clinics?

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US stem cell will comply with a court ruling in Florida, however, it will adjust their technique to use patient’s bone marrow rather than fat as a source for their own stem cells.

In fact, the lawsuit and this court ruling is a consequence of the increased enforcement by the FDA.

Given clinics in the industry have encountered regulation and scrutiny from prospective patients in the last 12 months, many clinics have responded with changes to their promotional messaging and, in some cases, their clinical trial procedures.

Moreover, chief executive Mike Tomas said “we know cutting-edge therapies can take time to be fully understood and endorsed.” He continued by expressing: “ it is important for us to maintain a portfolio of proven products and services each patient can choose from based on his or her own needs”. “It’s good business and it’s good medicine.”

Furthermore, the FDA’s lawsuit against U.S. Stem Cell is among several cases with stem cell clinics in the US. These cases require huge resources. The judge’s decision comes following a year of extensive motions, reports, as well as court filings. 

Finally, while the FDA has the authority to regulate the industry, their claim that stem cell therapy is a medication or drug is misleading since the biological material is drawn from a patient and reinjected into the same individual patient.

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