Search Results for: stromal vascular fraction

Clinic does stem cell penis growth injection: fact check

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When I read about a stem cell penis growth injection, what comes to mind first when you read that is “Ow!” The goal of today’s post is to fact-check this whole area. What’s in this article Stem cell penis growth | Risks |US Stem Cell Clinic claims |Does it work? | Does size matter? | Data check …

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

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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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Fat stem cells are drugs & more: FDA final guidances point to a new era

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Are fat stem cells a drug? Today the FDA definitively indicated “yes” without leaving much of any room for exceptions on this question. This morning the FDA made a major announcement on stem cell policy regarding its current thinking on oversight of regenerative medicine and issued four guidances, including two each in final and in …

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New FDA Inspection 483s: Insights on Stem Cell Clinic & Cell Surgical Network

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Two new FDA inspection reports called 483s provide fresh insights on a stem cell clinic, the network of clinics that it belongs to, and adverse events in patients. These reports detail issues the FDA found at the stem cell clinic California Stem Cell Treatment Center and its parent chain of clinics, Cell Surgical Network. The …

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

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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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Blogging today’s FDA stem cell meeting: Part 2 Clinics, Policy & Ethics

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The FDA is holding its first 2016 stem cell meeting today and you can read about some impressions of the morning session of this meeting here. In this post, I’m focusing on the afternoon session, which has been mostly on policy and ethics, including on stem cell clinics. Jonathan Kimmelman from McGill University got the afternoon going …

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Providing key context for my quote in WSJ on fat stem cell clinics

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Journalist Melinda Beck has a new piece on fat stem cell clinics in the Wall Street Journal (WSJ) today that includes one very brief quote from me that I believe effectively ends up being an unintentional misquote because of a lack of context. Here in this blog piece I want to provide that important missing …

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‘Are fat stem cell clinics selling unapproved drugs?’ reporters ask in talking about our new paper

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Our new paper in the journal Cell Stem Cell on the large stem cell clinic marketplace in the U.S. documented a wide range of different kinds of clinics, stem cells used, and conditions claimed to be treated, but here I want to focus on the fat stem cell clinics in this post. I’m going to try …

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FDA warning points to tougher regulation of fat stem cells & clinics

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Last week I blogged about how the FDA had issued a warning letter to a series of three co-owned fat stem cell clinics across the US. What does this FDA action mean on the broader stem cell clinic arena, particularly to those selling fat stem cells? The FDA is still in the process of getting public comment …

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