June 2, 2020

The Niche

Knoepfler lab stem cell blog

fat stem cells

3 min read

In a precedent-setting decision, a federal court has ruled for the FDA against a key stem cell clinic firm called U.S. Stem Cell, Inc. The court granted summary judgment for the FDA in its suit seeking a permanent injunction against the Florida stem cell clinic firm. While the company is likely going to appeal, this is a major defeat for them and for the hundreds of other unproven fat stem cell clinics in the U.S. It’s a big victory for science, regenerative medicine, and patients. …Read More

3 min read

Institutional review boards or IRBs are some of the biggest enablers of risky, unproven stem cell clinics. We often see statements on stem cell clinic websites to the effect that they have approvals from IRBs so the clinic firms must think that patients like to see that. Why would specific IRBs approve for-profit “experiments” by stem cell clinics using unproven fat stem cell injections, which are now clearly defined by the FDA as unapproved drug products being marketed unlawfully by clinics? First, let’s ask …Read More

3 min read

In a surprising development, the United States government (FDA and DOJ) and the stem cell clinic firm, US Stem Cell (USRM), Inc., that it has sued seeking a permanent injunction, have agreed on something! According to new court records on Pacer (see screenshot), they have both given up on mediation in the federal lawsuit. Further, they are both filing motions asking for summary judgment and asked for more pages to make their respective arguments. Things are moving fast now. Everything is due tomorrow to …Read More

5 min read

When the FDA has a major problem with something, it can issue a warning letter or more rarely it can file suit in court for an injunction against the particular party. The FDA has now done both of these things on different fronts with Beverly Hills stem cell clinic doctor and cosmetic surgeon, Dr. Mark Berman. Berman and his clinic partner, urologist Elliot Lander, run an adipose stem cell firm called California Stem Cell Treatment Center. This clinic seems effectively to also be the HQ …Read More

4 min read

The US has been bursting at the seams with unproven stem cell clinics for years, which in my view necessitates some kind of bold action by the FDA and other governmental agencies so I’ve wondered what new FDA Commissioner Dr. Scott Gottlieb would do on this front. The lead up to and beginning of a likely crackdown A subset of these clinics are particularly risky and egregious in their behavior. While this subset constitutes may be “only” one or two hundred such clinics out …Read More

2 min read

Is fat-free always a good thing…even for unproven stem cell clinics? It must be a challenge for a stem cell clinic firm like US Stem Cell, Inc. (USRM) to face an imminent possible future where it cannot sell injections of its main product, fat stem cells, in the US. After all, “US” and “Stem Cell” constitute its name. Ouch. It’s probable that a year or so from now the FDA lawsuit against USRM will be over and the “fat stem cell lady” will have sung …Read More