Search Results for: stromal vascular fraction

FDA Warning Letter to Irvine Stem Cell Treatment Center Clinics Across US

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The FDA has sent a Warning Letter to the Irvine Stem Cell Treatment Center. The leader of Irvine Stem Cell Treatment Center is Dr. Thomas Gionis and the letter was addressed to him. Interestingly, this letter, dated December 30, 2015, contains redactions. At one time this clinic was part of the larger Cell Surgical Network (CSN) …

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More tough FDA draft guidance on stem cells…still no action

FDA

The FDA released more draft guidance with strong relevance to the stem cell field. This October 2015 new draft guidance follows about a year after three other previous draft guidances that made it clear the current FDA thinking on various issues including stromal vascular fraction (SVF; fat stem cells) was much more restrictive than generally …

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My new ‘neighbor’ in Sacramento: a fat stem cell clinic

Thomas-A.-Glonis1

For years I’ve been writing about fat stem cell clinics that sell non-FDA approved stem cell “treatments” to vulnerable patients right here in America. These clinics have been sprouting up like mushrooms across the US and their numbers may be above 200 today overall. As a result perhaps it was inevitable that one would arrive in …

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Stem cells sold for better sex part 2: bigger & better penis?

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Does size matter when it comes to a guy’s penis? Can a man get bigger and could he do it via stem cells? Today’s post is the 2nd in a series on stem cells being sold allegedly for a better sex life. You can read the first post here. An increasing number of men around the world …

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FDA Interstate Commerce Regs Surprisingly Broad, Major Implications for Stem Cell Clinics

FDA

The FDA mandate to regulate drugs and devices often invokes a term called “interstate commerce”. Like many people I thought I knew what that meant, but probably like most people I was wrong. After a great discussion on an original post on various key issues related to the many stem cell clinics doing non-FDA approved …

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Stem cell clinics, FDA, & giant, unapproved for-profit human experiments

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When I started blogging in 2010 the stem cell arena was a very different place including the fact I could count the number of US stem cell clinics on one hand. This blog, called The Niche for many years, was just “Knoepfler Stem Cell Blog” back then. Also, back then the hot topic was the …

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FDA to Put Mushrooming Fat Stem Cell Clinics on Crash Diet?

Stembucks, stem cell cartoon

Is it the beginning of the end for dubious American clinics that sell transplants of unproven and non-FDA approved fat stem cell injections? As the year of 2014 was winding down, the FDA issued two key new draft guidances (see here and here) that could prove to be crash diets for these burgeoning fat stem cell clinics. (Update: As of …

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FDA Draft Guidance Views Fat Stem Cells As Drugs

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With a new document released today the FDA is more clearly on a path to regulate dubious stem cell clinics in the US. Update: in the years since this post, the FDA has more concretely defined autologous adipose stem cells as drug products. There are more than 100 such American clinics that are selling stem …

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New Interview with FDA on Key Stem Cell Regulatory Issues & Its Own Research

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It’s been a seemingly rather quiet year on the regulatory front in the US when it comes to direct-to-consumer stem cell interventions even as the number of dubious stem cell clinics continues to skyrocket. I requested an interview with the FDA to cover the key pressing issues in this arena. I want to thank the …

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