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The FDA released more draft guidance with strong relevance to the stem cell field. This October 2015 new draft guidance follows about a year after three other previous draft guidances that made it clear the current FDA thinking on various issues including stromal vascular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More tough FDA draft guidance on stem cells…still no action Read More »
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
My new ‘neighbor’ in Sacramento: a fat stem cell clinic Read More »
Stem cell biotech company Bioheart ($BHRT) has had a rough 2015 so far. Could this year be a decisive, negative tipping point for the company? It has a number of clinical trials going, but from my view things seem increasingly uncertain. An oddity amongst stem cell biotechs, Bioheart and its leadership have at times seemed to toy
Bioheart on the edge in 2015? Read More »
I invited the Chief Scientific Officer (CSO) of Bioheart, Kristin Comella, to do an interview after hearing some buzz that this could be a critical time for the company and that it might have been recently visited by the FDA. Note that Comella not just Bioheart CSO, but also the primary instructor for physician training in stem
Interview with Bioheart CSO, Kristin Comella including on FDA Read More »
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
Stem cells sold for better sex part 2: bigger & better penis? Read More »