June 3, 2020

The Niche

Knoepfler lab stem cell blog

U.S. Stem Cell Inc

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

5 min read

We’re seeing more muddy waters in the stem cell universe. A chiropractic stem cell and alternative medicine clinic has popped up calling itself, of all things, CIRM. On another front, an already controversial docuseries set to air tomorrow combines interviews with prominent academic stem cell scientists and unproven stem cell clinic folks, muddying the waters. Was that the goal? What’s the deal? As to the stem cell clinic referring to itself as CIRM, some of us in the stem cell world already know of …Read More

3 min read

Do the hundreds of unproven fat stem cell clinics in the U.S. like Stemgenex have a tenable future without working with the FDA? It seems less certain now in 2018 than it did in 2017, and that’s a good thing in my view. Stemgenex received an FDA warning letter yesterday that included a list of many troubling issues at the clinic. This warning letter just adds to difficult issues facing this clinic firm including a proposed class action patient lawsuit against it that that could get class …Read More

2 min read

Take our poll: what will be the fates of the stem cell clinic firms sued by the FDA one year from now in October 2019? To be clear, I am asking for your predictions, not what you hope will be the situation a year from now. U.S. Stem Cell, Inc. (USRM) and California Stem Cell Treatment Center along with its parent stem cell clinic chain Cell Surgical Network were separately but in parallel sued in May by the FDA via the DOJ seeking permanent injunctions …Read More

7 min read

At the request of the FDA, the DOJ is suing for permanent injunctions against two stem cell clinic firms, U.S. Stem Cell, Inc. and California Stem Cell Treatment Center (and for the latter, its parent chain of around 100 clinics, Cell Surgical Network). What does this big development mean in practical terms and how might it play out? For some discussion and potential answers, I turned again to Professor Patricia Zettler of George State University School of Law, an expert on stem cell oversight, the …Read More

3 min read

Below are the 2016 stem cell predictions I made last year and their status now color-coded near year’s end. Green is right, orange is mixed bag, and red is flat out wrong. Overall, I did better than most past years with only having entirely blown it on four. Stay tuned later this week for my 2017 predictions, which looks to be a dramatic year in the field of stem cells and regenerative medicine. The Score Card on 2016 Predictions Another stem cell biotech acquisition by pharma …Read More