In the latest blow to the unproven stem cell clinic industry, a California federal district court judge just granted class status to a lawsuit against the fat stem cell clinic Stemgenex. (update: Stemgenex has since filed for bankruptcy). What this means in practical terms is that the lawsuit alleging fraud in marketing by the clinic …
It’s been a big week already for the stem cell field due to the court ruling against US Stem Cell Inc. and that the FDA can define stromal vascular fraction (SVF) as a drug (see my old rough sketch of how SVF is sometimes manufactured; my impression is that the company does this slightly differently). …
Reactions to historic stem cell clinic court loss, new court order, & what happens next? Read More »
Unproven stem cell clinics are facing a variety of lawsuits these days including two prominent cases filed by the FDA. There are widespread patient suits against clinics as well. In April we saw a new kind of suit in the form of the NY State Attorney General (AG) Letitia James filing against a Manhattan clinic. …
NY stem cell clinic pushes back on lawsuit by AG Read More »
It’s been less than a year since the FDA sued for a permanent injunction against a major stem cell clinic firm in Florida, but there has been much back and forth in court filings in the lawsuit between them and the firm, US Stem Cell. Now the case is with the judge. My prediction remains …
My take as a biologist on US Stem Cell “natural” claim in federal court case endgame Read More »
There are many potential causes of erectile dysfunction or ED and a host of ideas about how to treat it. Some approaches to erectile dysfunction are evidence-based and even have been rigorously proven such as the drugs Viagra and Cialis, which increase blood flow to the penis. Depending on the causes of the dysfunction, these …
Sexual Medicine Society on Unproven Regenerative Therapies for Erectile Dysfunction Read More »
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 »
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 …
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 »