American CryoStem

Sizing Up Sizzling FDA Warning Letter to Fat Stem Cell Clinic Stemgenex

Stemgenex

Do the hundreds of unproven fat stem cell clinics in the U.S. like Stemgenex have a tenable future without working with the FDA? It seems less certain now in 2018 than it did in 2017, and that’s a good thing in my view. Stemgenex received an FDA warning letter yesterday that included a list of many …

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Take-homes from new FDA NEJM stem cell piece including surprises

Peter-Marks-Scott-Gottlieb-FDA

FDA Commissioner Scott Gottlieb and CBER Director, Peter Marks, have just published a new piece on stem cells and regenerative medicine in the New England Journal of Medicine (NEJM). What are the core points here and what can we learn from reading between the lines a bit? There are some expected things and then some …

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FDA Issues 1st Stem Cell Warning Letter of 2018 to American CryoStem

SVF2

The FDA started off 2018 with a bang on the direct-to-consumer stem cell clinic front with a warning letter on January 3rd to American CryoStem, a firm involved in processing and distributing adipose stem cells. The company’s ATCELL™ adipose stem cell product was the focus of much of letter. The FDA indicated in the warning …

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Cell Surgical Network, largest group of US clinics, using lab-expanded stem cells in patients?

Elliot-Lander-Mark-Berman

Is the largest affiliated group of stem cell clinics in America, Cell Surgical Network, now using laboratory-proliferated stem cells in patients? Do they already have some kind of final FDA approval for this clinical approach given that lab-grown stem cells are generally viewed as drugs requiring premarket approval? Over the years I’ve reached out to …

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