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 »
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 »
I can see many reasons to be jolly on the regenerative medicine front as we get deeper into the holiday season as there is quite a lot of stem cell good news even if there is also some not so good news. In today’s post the focus is on the good news of late. Semma …
Stem cell good news for the holidays: biotechs, FDA, organoids Read More »
According to The Bismarck Tribune and the AP/US News & World Report, the North Dakota Attorney General’s office is investigating a stem cell clinic in that state amid complaints. From the news articles: “The clinic has been offering stem cell injections for about a week and a half. Consumer Protection Division Director Parrell Grossman says there are …
‘Very Alarmed’: North Dakota AG Investigating Stem Cell Clinic Read More »
In a nutshell, what does all of this week’s big FDA developments on stem cells and regenerative medicine mean for stem cell clinics? There’s much to be upbeat about so overall I’d say it’s good news, but I see three significant potential problems too. Dang. The good news is that the FDA seems determined to …
Deconstructing FDA Mixed Bag Approach to Stem Cell Clinics 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 »
The ability of for-profit stem cell clinics to pitch unproven, risky stem cell offerings to patients may soon get much tougher in Australia. The country’s Therapeutic Goods Administration (TGA), which has some similar responsibilities there as the FDA does here in the U.S., announced planned new reforms that’ll put stem cell clinics under more scrutiny and more …
Australia takes big step to curtail dangerous stem cell clinics Read More »
Right now the FDA has a big fat stem cell conundrum on its hands. The agency is faced with a tough dilemma as how to deal with fat (adipose) stem cell products and the large number of businesses who sell them. Are fat/adipose stem cells a drug or not? If yes, what does the FDA do …