Take our poll: what will be the fates of the stem cell clinic firms sued by the FDA one year from now in October 2019? To be clear, I am asking for your predictions, not what you hope will be the situation a year from now. U.S. Stem Cell, Inc. (USRM) and California Stem Cell […]
Polls on futures of stem cell clinics sued by FDA Read More »
Ain’t nothing like the real thing…right? No, by the ‘real thing’ I’m not talking about Coke versus Pepsi or Coke versus Diet Coke, but rather stem cells. (On a side note there’s still some people who apparently believe the stem cell myth that there are stem cells in Pepsi). I get a regular stream of
Stem-ish cells: what’s the real thing? Read More »
The FDA via the DOJ has sued to get permanent injunctions against US Stem Cell, Inc. (USRM) and California Stem Cell Treatment Center/Cell Surgical Network (CSN). Both firms use an unapproved fat stem cell product in patients called stromal vascular fraction (the SVF production process is pictured at right) that the FDA indicates is generally
10 questions on FDA suits targeting stem cell clinics Read More »
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 »
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 »
Are fat stem cells a drug? Today the FDA definitively indicated “yes” without leaving much of any room for exceptions on this question. This morning the FDA made a major announcement on stem cell policy regarding its current thinking on oversight of regenerative medicine and issued four guidances, including two each in final and in
Fat stem cells are drugs: new FDA final guidances Read More »
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 »
The stem cell clinic business US Stem Cell Inc., formerly known as Bioheart, has seen its stock take a rollercoaster ride recently include a big run up and now today a big drop so what’s the scoop? US Stem Cell, which includes a few subsidiaries such as US Stem Cell Clinic, focuses on the use
What’s the deal with US Stem Cell Inc stock? 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