Search Results for: amniotic

Reactions to California’s new stem cell law on non-FDA approved clinic offerings

February 1, 2021 / By / 6 Comments
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What does the wide stem cell and regenerative medicine community think of California’s new stem cell law requiring that clinics selling non-FDA approved stem cell offerings make specific disclosures to prospective customers and that the state medical board keep track of how this all unfolds? You probably already know that I am supportive of the …

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Customers rate Nervana stem cell clinic harshly on Yelp

February 1, 2021 / By / 11 Comments
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Sacramento’s Nervana stem cell clinic has been selling non-FDA approved stem cell therapies to patients for a variety of conditions including arthritis, pain, and neuropathy for a while now since last year, but in my opinion there isn’t good evidence to back up using amniotic or fat stem cells for such conditions. Further, my understanding …

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Six questions as FDA takes new shot at stem cell clinics

February 1, 2021 / By / 7 Comments
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The FDA issued a historic statement today promising to more clearly define its regulatory policies on stem cell therapies and to take strong action on some stem cell clinics that it views as “bad actors”. I’ve never the FDA use such clear-cut language before. I give big kudos to new FDA Commissioner Scott Gottlieb. It already …

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Reading the tea leaves as new FDA commish Gottlieb blogs on regenerative medicine

February 1, 2021 / By / 3 Comments
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New FDA Commissioner Dr. Scott Gottlieb, M.D., has in the past touched on stem cells and regenerative medicine therapies in speeches or written comments prior to starting his tenure at the agency. Now that he is Commissioner, he is poised to have direct impact on our field rather quickly and potentially with major changes in …

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

February 1, 2021 / By / 2 Comments
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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Tom Price & MiMedx: a stem cell connection?

June 6, 2022 / By / 5 Comments
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What’s the deal with Trump’s HHS Secretary pick Rep. Tom Price (now testifying before the Senate) and the amniotic tissue/stem cell company MiMedx that’s caused some buzz in the last 48 hours? I’ve been following MiMedx for a few years since it received an untitled letter from the FDA and I noted its claim of one its …

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Fake stem cell news

February 1, 2021 / By

One of my Top 20 Predictions for Stem Cells for 2017 was that we’d see more instances of fake stem cell news. One type of stem cell fake news consists of promotional press releases that seek to recruit paying customers for unproven stem cell “treatments” based on made up or exaggerated claims about safety and …

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Sacramento Nervana stem cell clinic spreads to San Diego

February 1, 2021 / By / 10 Comments
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It’s been an odd experience having a local stem cell clinic, called Nervana, here in Sacramento to watch in terms of how they handle things such as advertising. I’ve also heard quite a lot from people within our community asking about Nervana. Now the business is selling non-FDA approved stem cell therapies in San Diego …

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