FDA Commissioner Scott Gottlieb and CBER Director, Peter Marks, have just published a new piece on stem cells and regenerative medicine in the New England Journal of Medicine (NEJM). What are the core points here and what can we learn from reading between the lines a bit? There are some expected things and then some […]
Take-homes from new FDA NEJM stem cell piece including surprises Read More »
When I read about a stem cell penis growth injection, what comes to mind first when you read that is “Ow!” The goal of today’s post is to fact-check this whole area. What’s in this article Stem cell penis growth | Risks |US Stem Cell Clinic claims |Does it work? | Does size matter? | Data check
Stem cell penile growth fact check Read More »
What happens if we mix stem cells with populism? From a populist view of stem cells, everyday patients should be able to do nearly anything they want with stem cells without any governmental interference or excessive expense. Even stem cells not proven to be safe or effective. This can sound like an appealing idea to
Popping the bubble of stem cell populism Read More »
I’ve been blogging about stem cells now for about 8 years and the recent level of hype about and fluffy media coverage of Celularity, the biotech spun out of Celgene, ranks right up here with the most extreme past cases I’ve seen. What is Celularity and who is its leadership? It’s a new biotech focused
Just one word placentas: Can Celularity live up to hype? Read More »
I’ve got some TGIF recommend reads on stem cells, etc, but first, what a week, right? We need more action on preventing gun violence. It’s a uniquely American health crisis that doesn’t have to be. There’s no real, common sense reason that gun control can’t reduce mass killings of our kids and others like the
TGIF: Guns, stem cells, science weekends reads & good news Read More »
We have a big problem with clinics in the U.S. selling unproven and non-FDA approved stem cell “treatments” to patients and part of the reason in my view why we have this mess today with upwards of 700 such businesses from coast to coast is that regulators including both the FDA and state medical boards
Pending State Medical Boards Group Report on Stem Cell Clinics Could be Game Changer Read More »
There’s some also encouraging action at the state level on direct-to-consumer stem cell clinics operating without FDA approval including most recently in Washington State. Last year here in California we passed a bill into law that (1) requires stem cell clinics selling non-FDA approved therapies to post notices for patients and (2) instructs the state medical
Washington State Bill to Require Unproven Stem Cell Clinics to Post Notices Read More »
The recent news that Texas A&M University has inked a full-blown deal with the direct-to-consumer stem cell clinic firm Celltex struck me as an unusual development. Recently we’ve seen more universities exploring the use of stem cells outside of the traditional FDA clinical trial process that is fundamentally based on an investigational new drug application (IND). Some
Why did Texas A&M ink big deal with stem cell clinic firm Celltex on exosomes? Read More »
Stem cell clinics marketing non-FDA approved therapies directly to consumers have been in various tense situations at times with the FDA or academics over the years, but more recently these stem cell clinic-related firms also appear in conflict with each other sometimes. The most notable recent example of conflict involves Dr. Christopher Centeno of Regenexx
Internecine conflicts among direct-to-consumer stem cell firms Read More »
Stem cells for flu? For me, that idea is new. Some months back there was buzz about the stem cell biotech Longeveron related to its report on early trial data on testing infusions of mesenchymal stem cells for frailty in the aged. Frailty that pops up in some aging folks can manifest in a variety
Stem cells for the flu? Pondering PR email, frailty data from Longeveron Read More »