The New York State Attorney General (AG) filed suit this week against a Manhattan stem cell clinic. It’s a landmark case. The defendants are Image Plastic Surgery, LLC, Park Avenue Stem Cell, and Joel B. Singer, M.D. The clinic markets adipose stem cell injections for a variety of health conditions. Park Avenue Stem had belonged […]
Why NY AG suit against Manhattan stem cell clinic is such a big deal Read More »
Who decides whether a stem cell therapy is “good” or “bad”, and should that kind of a judgment be more focused on direct patient perspectives such as their stem cell therapy reviews as consumers or based on biomedical science? Both? I’ve written before about how stem cell patients are increasingly thinking of themselves as consumers
Stem cell therapy reviews: knees, lung, autism, & Regenexx Read More »
What is the SCOTS Trial and why are some of its participants raising concerns? There’s a lot going on in Florida with non-FDA approved stem cell offerings. Even just related to stem cells for vision problems alone. While US Stem Cell has drawn the most attention related to patient allegations of severe vision loss in Florida
15 still unanswered interview questions for stem cells for vision SCOTS trial docs Read More »
At the request of the FDA, the DOJ is suing for permanent injunctions against two stem cell clinic firms, U.S. Stem Cell, Inc. and California Stem Cell Treatment Center (and for the latter, its parent chain of around 100 clinics, Cell Surgical Network). What does this big development mean in practical terms and how might it
Helpful Zettler insights from Q&A on FDA suits against stem cell clinics Read More »
Is “snake oil” too harsh a term for some of what is sold at some of the worst stem cell clinics? Is the phrase “stem cell clinics” itself accurate and useful in a broad sense? When we read or write the phrase “stem cell clinics”, most people generally know what we’re talking about, but it
What should we call “stem cell clinics” & is “snake oil” too harsh for some? 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 »
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 »
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 »