By Jeanne Loring Paul did a good job of giving an overview of the FDA meeting today. Being in the room, I have a few observations that complement Paul’s. I’ve never been to a meeting like this- there were 42 scheduled 5 minute presentations, and this is just the first of 2 days. The question […]
Jeanne Loring’s Report from Inside FDA Stem Cell Meeting Day 1 Read More »
Today was the first part of the FDA’s 2-day meeting on stem cell draft guidances. It was a great meeting I thought. A few consistent themes and notable things emerged as raised by participants.
8 key arguments, take-homes on day 1 of FDA stem cell meeting Read More »
The FDA’s CBER branch recently issued a warning letter to Amniotic Therapies, LLC. The warning letter pertains to both AlphaGEMS-related products that are used by a number of stem cell clinics as well as problems determined at the manufacturing facility. I went to the Amniotic Therapies website, but perhaps not coincidentally it is down, which
FDA warning to Amniotic Therapies, LLC: impact on stem cell clinics? 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 »
A stem cell/regenerative clinic firm called the Lung Institute is facing a filing of a proposed class action suit. Update: Note that this firm also goes by the name the Lung Health Institute and now as of 2019-2020 it does not appear to offer stem cells anymore, perhaps focusing on PRP. You might also find
Class Action Lawsuit Filed Against Clinic Lung Institute Read More »
The journal Nature published an excellent editorial earlier this week on stem cell oversight and stem cell clinics. The piece, entitled ” FDA should stand firm on stem-cell treatments. US regulators must regain the upper hand in the approval system” struck just the right balance. It correctly supported the FDA’s data-centered approach to stem cell oversight and
Perspectives: Nature editorial on stem cell oversight & clinics gets it right 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
My colleague Leigh Turner and I today published a new paper in Cell Stem Cell documenting for the first time the American stem cell clinic arena in a comprehensive way, which we found as of February has a remarkable 570 clinic locations via 351 businesses. These numbers are way beyond the predictions of most researchers
New paper with Leigh Turner shows huge American stem cell clinic industry: 570 locations Read More »
For better or worse, I am in the unique position of being a stem cell scientist and also a former cancer patient. Looking on the bright side this gives me a unique perspective on things compared to many of my colleagues. I know there are thousands of people out there looking for more practical information
Patients guide to stem cell treatments for 2021 Read More »
Jill Howlin’s drawings about science and policy have a unique, edgy style that packs a punch. I have invited her to weigh in here now and then with new illustrations that touch upon stem cell or other innovative biomedical matters. Jill’s new drawing today relates to some key stem cell issues such as clinical safety, choice of stem cells, homologous
Stem cells run amok: Jill Howlin’s satirical cartoon look Read More »