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, I wonder how much data there are on this. 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 |Who is
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 »
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 are appearing more often in pop culture including movies like Spiderman, newspaper articles (and advertisements), just about a year ago on Dr. Oz, and now yesterday for the first time that I remember in the New York Times (NYT) crossword puzzle. There I was doing the NYT puzzle last night while munching a
Stem cells pop up in pop culture including New York Times crossword Read More »
The FDA started off 2018 with a bang on the direct-to-consumer stem cell clinic front with a warning letter on January 3rd to American CryoStem, a firm involved in processing and distributing adipose stem cells. The company’s ATCELL™ adipose stem cell product was the focus of much of letter. The FDA indicated in the warning
FDA Issues 1st Stem Cell Warning Letter of 2018 to American CryoStem Read More »
Every year I look into my stem cell crystal ball and make predictions for our field including regenerative medicine. Well, I don’t really look into a crystal ball, but I try to use a combination of what I’m hearing through the grapevine, stuff I’m reading, some info that is not yet in the public domain,
20 predictions for stem cells & regenerative medicine in 2018 Read More »
A new stem cell clinic lawsuit has popped up and this one, like some others, relates to a patient alleging vision loss due to a non-FDA approved stem cell offering and involves U.S. Stem Cell, Inc. (formerly called Bioheart). American stem cell clinics market direct-to-consumer stem cell offerings for a whole medical dictionary’s worth of
New lawsuit against U.S. Stem Cell also alleges blindness Read More »
Each year I make a list of predictions for the year to come for the stem cell and regenerative medicine field. Then about a year later I grade myself on how I did as that year winds down. Here’s how I did in 2016. For 2017, late in 2016 I made 20 stem cell predictions. Let’s
Grading my twenty 2017 stem cell predictions Read More »