July 10, 2020

The Niche

Knoepfler lab stem cell blog

fat stem cells

5 min read

It was fascinating to read a new JAMA piece by the FDA on unproven stem cell clinics and other regenerative medicine firms. Many of these guys are profiteering off of buzz about exciting, but mostly unproven technologies. While the JAMA opinion piece reiterates the agency’s commitment to evidence-based regenerative medicine, it also makes some other key points, some of which are newer and worth digging into on a deeper level. What’s new here from the FDA? The piece by CBER Director Dr. Peter Marks …Read More

5 min read

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 judgment 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 permanent injunction. You can read the new ruling here. The reasons why Bernal said he rejected the summary judgment request are concerning and don’t fit with my view of …Read More

2 min read

How much money and how many patients do stem cell clinics like San Diego’s StemGenex make each year? A new court document has some insights from an unexpected angle. I’ve been following StemGenex for years here on The Niche. It’s been a rollercoaster ride. Things hit a new low today, perhaps marking the operational end of the company, but we’ll see. StemGenex has marketed non-FDA approved fat stem cells for a variety of health conditions. Their marketing is central to a patient class action …Read More

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