July 15, 2020

The Niche

Knoepfler lab stem cell blog

FDA

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

3 min read

Maybe the announcement that Commissioner Scott Gottlieb will be leaving the FDA soon shouldn’t have caught us all off-guard, but it did. Gottlieb isn’t a perfect Commissioner, but he brought a sensible, open approach to running the FDA that was very refreshing. Amongst all the top leadership in the Trump administration, Scott Gottlieb stood out as being particularly supportive of his agency and its core mission. If anything he was the anti-politician in the room. Is that what did him in? It’d be helpful …Read More