fat stem cells

Celltex unsure if FDA agrees product isn’t a drug, but expects 2nd FDA visit soon

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I recently asked Celltex if they had definitely convinced the FDA their product was not a drug (i.e. the FDA confirmed their product was not a drug) or rather they had tried and hoped they had. It appears the latter is correct from the Celltex response below: Dear Dr. Knoepfler, Thank you for your interest …

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Court empowers FDA to regulate stem cells as drugs

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Are stem cells drugs? At least for today, a federal court unambiguously ruled that the answer to this question for manipulated stem cells is “Yes”.  The story has been reported in the media at New Scientist and Scope Blog. You can read over the key issues here. The court ruled in favor of the federal government and FDA and against …

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Surprising FDA audit report of Celltex a blow to dubious stem cell clinics

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As I first reported, the FDA conducted a two-week audit of Texas adult stem cell firm, Celltex, sometime in April. Today I received a copy of the so-called “483 report” of that audit. It is basically a summary of problematic issues that the FDA says need to addressed. The FDA report is cause for some …

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