We need more investigations of for-profit stem cell clinics selling what some view as ‘snake oil.’ Over the years I’ve mainly resisted using terms like “snake oil,” but that phrase is being used more often and more recently I think we need to be blunt about what is being sold. Part of effectively countering the […]
Several new investigations expose ‘snake oil’ stem cell clinics Read More »
Do the hundreds of unproven fat stem cell clinics in the U.S. like Stemgenex have a tenable future without working with the FDA? It seems less certain now in 2018 than it did in 2017, and that’s a good thing in my view. Stemgenex received an FDA warning letter yesterday that included a list of many
Sizing Up Sizzling FDA Warning Letter to Fat Stem Cell Clinic Stemgenex Read More »
I have a new Cell Stem Cell piece out today that aims to take stock of today’s stem cell regulatory oversight in the U.S., Japan, and elsewhere including Australia, Canada and India. I use a carrot and stick metaphor for encouraging legit research and taking regulatory action on serious non-compliant activities, respectively. Where is stem cell
My new Cell Stem Cell piece: too much carrot & not enough stick on stem cell oversight 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 »
If the FDA can “go big” to issue 40 warning letters to the e-cig industry as it just yesterday, why has it recently only issued 1 or fewer warning letters per year to the unproven, for-profit stem cell clinic industry in the U.S., which includes hundreds of businesses blatantly operating in what seems to be a
40 FDA warnings to e-cig biz, but stem cell clinics allowed to keep blowing smoke Read More »
Early in 2016, we started hearing about patient allegations of having been blinded in Florida by at least one stem cell business and several allegations seemed linked to a publicly-traded company called U.S. Stem Cell, Inc. (USRM). In turn, there have been a number of lawsuits involving USRM, including one filed just a few months
Sen. Grassley asks tough questions for FDA on U.S. Stem Cell, blinded women 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 »
Did you hear the one about the deep state FDA, big pharma stem cell conspiracy theory? This is the phony idea that the FDA, big pharma, and, heck, sometimes even certain academics (who could that be?) are plotting together as some kind of biomedical secret society or “deep state” to block promising stem cell therapies
Predatory clinics push stem cell secret society, deep state conspiracy theory 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 »
How far will stem cell clinics go to market their non-FDA approved “treatments” that they often claim will have miraculous results? I’ve never seen anything quite as striking as what some clinics in the Seattle area are now doing. In the past, we’ve seen clinics take researchers’ pictures, quotes, or videos to use for their
Seattle clinic uses FDA commish in marketing non-FDA approved stem cells Read More »