June 6, 2020

The Niche

Knoepfler lab stem cell blog

US Stem Cell

5 min read

Each year I make a list of stem cell predictions for the following year and I’ll release my predictions for 2019 soon, but first I’m grading how my 20 predictions for 2018 turned out. It seems I did better than usual predicting what would happen this year. I only got a couple partial credit or were hard to grade. The rest were right. Here are my 20 predictions verbatim that I made in late 2017 for what would happen in 2018. 1. Combo cell-gene …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

3 min read

The FDA via the DOJ has sued to get permanent injunctions against US Stem Cell, Inc. (USRM) and California Stem Cell Treatment Center/Cell Surgical Network (CSN). Both firms use an unapproved fat stem cell product in patients called stromal vascular fraction (the SVF production process is pictured at right) that the FDA indicates is generally going to be a drug product requiring premarket approval. You can see my first quick take on these federal suits here as well as initial responses to the suits …Read More

2 min read

It was interesting to see that this blog The Niche was cited in the lawsuit filing by the DOJ in the U.S.A. vs. California Stem Cell Treatment Center, Cell Surgical Network (CSN), et al. case. Yeah, that lawsuit. This suit is part of the DOJ action yesterday that along with the other suit against US Stem Cell seeks permanent injunctions against these firms related to their use of stem cells. Here’s the passage in paragraph 60 of the suit by the DOJ citing this interview that I …Read More

3 min read

I emailed the CSO of US Stem Cell, Kristin Comella, for any reaction to today’s big news of the DOJ filing suit against two stem cell clinic firms including hers seeking injunctions. I also emailed the leaders of the other firm, California Stem Cell Treatment Center/Cell Surgical Network. It’s important to include the clinic firms’ perspectives for balance as this story develops. US Stem Cell’s PR firm and Cell Surgical Network both emailed back. US Stem Cell has issued a response to the action …Read More

4 min read

The DOJ and FDA are seeking permanent injunctions in federal court against two of the most widespread and influential of the for-profit, unproven stem cell clinic firms in the U.S. This story is breaking so I’ll have more later this week. The take home is that I see this action as a positive, probably historic turning point for dealing with the for-profit stem cell clinic problem in the U.S. Update: US Stem Cell says it intends to fight the DOJ in court. According to the Washington …Read More