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 […]
New FDA Inspection 483s: Insights on Stem Cell Clinic & Cell Surgical Network Read More »
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
Reading the tea leaves as new FDA commish Gottlieb blogs on regenerative medicine Read More »
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
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
Blogging today’s FDA stem cell meeting: Part 2 Clinics, Policy & Ethics Read More »
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
Providing key context for my quote in WSJ on fat stem cell clinics Read More »
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
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
To stem cell clinics: do your homework & take FDA “current thinking” seriously Read More »
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
FDA warning points to tougher regulation of fat stem cells & clinics Read More »
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)
FDA Warning Letter to Irvine Stem Cell Treatment Center Clinics Across US Read More »
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
More tough FDA draft guidance on stem cells…still no action Read More »