Month: August 2016

FDA warning to Amniotic Therapies, LLC: impact on stem cell clinics?

Amniotic-Therapies

The FDA’s CBER branch recently issued a warning letter to Amniotic Therapies, LLC. The warning letter pertains to both AlphaGEMS-related products that are used by a number of stem cell clinics as well as problems determined at the manufacturing facility. I went to the Amniotic Therapies website, but perhaps not coincidentally it is down, which …

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

SVF2

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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Class Action Lawsuit Filed Against Clinic Lung Institute

The-Lung-Institute

A stem cell/regenerative clinic firm called the Lung Institute is facing a filing of a proposed class action suit. Update: Note that this firm also goes by the name the Lung Health Institute and now as of 2019-2020 it does not appear to offer stem cells anymore, perhaps focusing on PRP. You might also find …

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3 more FDA warning letters to stem cell cosmetics makers

Resurgent-Stem-Cell-Firming-Activator

The FDA continues to be very active with warning letters against makers of stem cell cosmetics even as it has been relatively dormant on stem cell clinics. You can read past posts on the long series of warning letters to manufacturers of stem cell cosmetic cream. Three new warning letters to stem cell cream makers …

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Outcome of FDA stem cell meeting likely to please no one

FDA-draft-guidance

It’s been a big 2 weeks in terms of media interest in talking about the upcoming FDA meeting on stem cell oversight taking place in just a few weeks. There are many questions about this meeting and I’m planning to tackle some of the questions in upcoming posts including next week. These questions include, “who …

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Where are all the new CRISPR human embryo papers?

embryo-human

Last year I heard from several sources that there somewhere between 3-5 unpublished manuscripts reporting the use of CRISPR gene targeting in human embryos being shopped around at various journals in addition to the one that had been published. Since that time we’ve seen a grand total of one additional paper reporting on CRISPR of human …

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LA Times Shines Some Light on Stem Cell Clinics including StemGenex

StemGenex

A large and growing number of American clinics are selling stem cells to patients for a variety of ills and one in the San Diego area called StemGenex was the main focus of a recent LA Times piece by columnist Michael Hiltzik. In the piece called “These new stem cell treatments are expensive — and …

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Some weird posts: testicle soup, Kim Kardashian, zombies

kardashian-vampire-facial

After six and a half years blogging here, I’ve seen so much weird stuff. Not all of it was even “bloggable” due to its crazy, not-safe-for-work nature. For TGIF this week, here are 10 of the weirdest posts from this blog over the years. Where’s the Beef? Reality Check on Stem Cell Test Tube Burger …

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Possible class action lawsuit against stem cell clinics

stem-cell-clinics-southern-california-e1471543154180

I often am asked if there are ongoing or possible upcoming lawsuits against stem cell clinics. Doing periodic searches such as on Google is one way to learn more about whether there are stem cell legal cases out there. Recently I did such searches for a variety of terms including “stem cell lawsuit” and “stem …

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