Search Results for: warning letter

Rick Perry’s Paid Board Position at Controversial Stem Cell Clinic Celltex

Perry-Scripps

If you rewind the stem cell clock several years, the big news in the stem cell clinic arena was dominated for quite some time by a single stem cell clinic called Celltex in Texas in part because their most famous customer was Governor (at that time) Rick Perry. You can read the many past posts I’ve […]

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What happens next with FDA & stem cells: lower your expectations?

FDA

In the total the FDA has held 3 days of public meetings on stem cells in the last few weeks ranging from science to policy and hearing from many parties including patients and even stem cell clinics so the big question now is, “what happens next?” The FDA has 4 draft guidances pertaining to investigational

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Guide to September 12-13 FDA Stem Cell Meeting

Stembucks, stem cell cartoon

The FDA is holding a 2-day stem cell meeting starting tomorrow and it promises to be a really big deal. What’s the scoop on this meeting and the attendees? Who is likely to say what? If the deregulatory proponents get their way, could we have stem cell clinics like Starbucks popping up in even more neighborhoods? I have

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Federal judge blocks FDA action on Texas amniotic supplier

FDA-judge-amniotic

The FDA issued a warning letter not long ago to Amniotic Therapies, LLC, a supplier of amniotic products including to one or more stem cell clinics, but now a federal judge in Texas has reportedly mostly blocked the FDA action in terms of the shutdown. The law firm representing Amniotic also issued a PR about the

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

SVF2

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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To stem cell clinics: do your homework & take FDA “current thinking” seriously

SVF2

One of the difficult things about the regulatory sphere that covers stem cells in the US is that many aspects are confusing or puzzling both to the public and so-called experts. We’ve been talking through some of the questions that come up in this area in posts and comments on this blog. What does a warning

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Content Wiped on Websites of Stem Cell Clinics Warned by FDA

Irvine-Stem-Cell-Treatment-Center

A couple of months back, the FDA issued a warning letter to three co-owned stem cell clinics selling fat stem cell-based interventions to patients for a variety of ills. You can read all about the warning letter here. It went to lead clinic, Irvine Stem Cell Treatment Center as well as the two co-owned clinics, which

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Predatory stem cell clinics are winning: what can we do?

Stem-cell-facelift-comic-e1452454386279

For years I have been working to educate the community about the predatory stem cell clinics out there. These clinics prey on vulnerable patients and their families. The clinics use hope as a marketing tool. A weapon. As the number of such clinics has mushroomed in the US and elsewhere the risk to both patients

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