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 »
Hat tip to North Dakota! You probably know by now that there are stem cell clinics in just about every state in the U.S. and some states and metro areas are hot spots. Heck, some of you reading this probably run such clinics. But did you know that of all the states, arguably North Dakota
Key takeaways from unique North Dakota action on stem cell clinic Read More »
Does a new lawsuit including Cell Surgical Network and its leadership as defendants pose a broad test to this entire chain of stem cell clinics, which may be the largest such affiliated clinic group in the U.S. and potentially even in the world? Will lawsuits substantially impact stem cell clinics? Lawsuits against unproven, for-profit stem cell
New lawsuit includes big stem cell clinic chain, Cell Surgical Network 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 »
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 »
New FDA Commissioner Dr. Scott Gottlieb, M.D., has in the past touched on stem cells and regenerative medicine therapies in speeches or written comments prior to starting his tenure at the agency. Now that he is Commissioner, he is poised to have direct impact on our field rather quickly and potentially with major changes in
Reading the tea leaves as new FDA commish Gottlieb blogs on regenerative medicine 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
The FDA is holding its first 2016 stem cell meeting today and you can read about some impressions of the morning session of this meeting here. In this post, I’m focusing on the afternoon session, which has been mostly on policy and ethics, including on stem cell clinics. Jonathan Kimmelman from McGill University got the afternoon going
Blogging today’s FDA stem cell meeting: Part 2 Clinics, Policy & Ethics Read More »