adipose stem cells

My take as a biologist on US Stem Cell “natural” claim in federal court case endgame

SVF2

It’s been less than a year since the FDA sued for a permanent injunction against a major stem cell clinic firm in Florida, but there has been much back and forth in court filings in the lawsuit between them and the firm, US Stem Cell. Now the case is with the judge. My prediction remains …

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Clinic versus clinic? Internecine conflicts among direct-to-consumer stem cell firms

Regenexx-blog

Stem cell clinics marketing non-FDA approved therapies directly to consumers have been in various tense situations at times with the FDA or academics over the years, but more recently these stem cell clinic-related firms also appear in conflict with each other sometimes. The most notable recent example of conflict involves Dr. Christopher Centeno of Regenexx …

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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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Seattle clinics use FDA commish in marketing non-FDA approved stem cells

Generation-stem-cell-clinic-ad-Seattle-Times

How far will stem cell clinics go to market their non-FDA approved “treatments” that they often claim will have miraculous results? I’ve never seen anything quite as striking as what some clinics in the Seattle area are now doing. In the past, we’ve seen clinics take researchers’ pictures, quotes, or videos to use for their …

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How Scott Gottlieb may transform the FDA’s approach to stem cells

Dr.-Scott-Gottlieb

The Trump FDA commissioner nominee Dr. Scott Gottlieb could dramatically alter how the agency regulates investigational stem cell therapies. How might such changes unfold? There are potential upsides and downsides to  the seismic shift that could be in the offing. Gottlieb has written in the past about his perception of FDA over-regulation of stem cells such …

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New paper shows huge American stem cell clinic industry: 570 locations

Stem Cell Clinics Map

My colleague Leigh Turner and I today published a new paper in Cell Stem Cell documenting for the first time the American stem cell clinic arena in a comprehensive way, which we found as of February has a remarkable 570 clinic locations via 351 businesses. These numbers are way beyond the predictions of most researchers …

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Stem cells run amok: Jill Howlin’s satirical cartoon look

Jill-Howlin-stem-cell-treatment-run-amok

Jill Howlin’s drawings about science and policy have a unique, edgy style that packs a punch. I have invited her to weigh in here now and then with new illustrations that touch upon stem cell or other innovative biomedical matters. Jill’s new drawing today relates to some key stem cell issues such as clinical safety, choice of stem cells, homologous …

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Interview with Bioheart CSO, Kristin Comella including on FDA

Kristin-Comella1

I invited the Chief Scientific Officer (CSO) of Bioheart, Kristin Comella, to do an interview after hearing some buzz that this could be a critical time for the company and that it might have been recently visited by the FDA. Note that Comella not just Bioheart CSO, but also the primary instructor for physician training in stem …

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