July 15, 2020

The Niche

Knoepfler lab stem cell blog

FDA

2 min read

US Stem Cell, Inc. reports in a new SEC filing that its key leader Kristin Comella has resigned as of September 1. I never thought I’d see the day when Kristin Comella and US Stem Cell, Inc. parted ways. To me Comella seemed like the driving force behind the company, which is now subject to an injunction after a big federal court loss. It is appealing the ruling, but faces a tough road ahead in my view. From the new SEC filing: “Effective September …Read More

4 min read

It can be kind of a big deal when politicians, especially at the federal level, write the FDA about stem cells. Is this going to be good news or bad? Some combination? I tend to worry that some senators or representatives might pressure the FDA to weaken oversight. However, lately it seems like the opposite is happening. Perhaps pressure the other direction, for less oversight, doesn’t see the light of day. Last April Senator Grassley wrote the FDA about problematic stem cell clinics and …Read More

4 min read

Today the United States District Court of the Southern District of Florida entered a permanent injunction against stem cell clinic firm US Stem Cell and co-defendants including U.S. Stem Cell Clinic. Patients have been harmed by the unproven treatments sold by these firms. US Stem had lost the case a couple weeks back, but now we know the details of the permanent injunction on them by Judge Ursula Ungaro. The order against US Stem, which is likely to be appealed, is appropriately strict in …Read More

5 min read

A fitness guru named Ben Greenfield has now reported self-injecting non-FDA approved stem cells from US Stem Cell. He says the stem cells came from a clinic that lost a big federal court case 9 days ago. Greenfield posted a Facebook video of the actual injection, which he narrates. There’s some text along with the video. Together they raises many troubling questions. Date of video vs. date of court ruling Greenfield says in the text describing the video that the stem cells were sent …Read More