In what could be a serious legal warning sign for the stem cell field, California federal district court Judge Jesus Bernal denied the government’s motion for summary judgement against Cell Surgical Network, et al. related to their marketing of an unproven fat stem cell product via their chain of clinics. The FDA is seeking a […]
Umbilical “stem cell” supplier Liveyon has suspended sales of its products according to the WaPo after a harsh FDA warning letter. While not fully shutting off the tap to the perinatal stem cell clinic universe, as other suppliers including in Utah seem to be continuing, this Liveyon voluntary hold will equal a major reduction in
Why did clinic supplier Liveyon halt sales but others kept going despite FDA? Read More »
I’m a biologist and genetics researcher, but as I have time I still squeeze in a little research on stem cell clinics when I can, and my new pub in Regenerative Medicine is notable for looking at changes in clinic firms in a unique kind of way. In the paper I went back to the
My Regenerative medicine pub tracking 100s of stem cell clinics over 3 years Read More »
The unproven stem cell clinic firm US Stem Cell Inc. is in a world of hurt. If a federal judge says you can no longer sell your key commercial offering, how do you survive as a company? US Stem probably has been thinking about that possibility for months. Still, it’s not yet clear where the
Can clinic biz US Stem reboot after losing suit? Its email to customers & more Read More »
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 »