Unproven stem cell clinic firm US Stem Cell and many others are apparently facing potential malpractice lawsuits. How it came to light via US Stem itself is somewhat surprising.
US Stem Cell and malpractice notice
The news popped up in an SEC filing by US Stem Cell, which I wasn’t even sure was still active as a business. The publicly-traded firm, whose stock price hovers near $0.00, listed several legal proceedings in this newest SEC filing. I’ll have more on those in a minute. A reader sent me a heads-up on the SEC filing.
Here’s the part with the surprise:
“On February 2, 2023, the Company received a notice of intent to initiate medical malpractice litigation. The Company is reviewing the notice and responding accordingly. The company was one of 11 entities and persons served with the notice.”
How do they happen to know and mention in the SEC filing that 10 other firms and/or people will be facing possible medical malpractice litigation too?
Who else is facing potential malpractice suits?
Who are these other firms or people?
Is there some connection between all eleven of them including US Stem?
It’s going to be interesting to find out who and what firms are involved.
Note that according to the SEC filing, former leader Kristin Comella is now running an independent entity called US Stem Cell Clinic, “On February 10, 2021, as part of a settlement agreement, the Company transferred its entire member interest in U.S. Stem Cell Clinic, LLC to Dr. Kristen Comella as settlement for $100,000 of accrued interest owed to Dr. Comella.”
This could be confusing for people since both firms’ names contain the phrase “US Stem Cell”.
Other US Stem legal proceedings
The list of other legal proceedings of US Stem Cell reminds us of the firm’s past issues including some patients.
- US Stem will pay hundreds of thousands related to the case of Jeannine Mallard.
- They said they had to pay $100,000 of an insurance deductible related to the case of Patsy Bade. Does US Stem Cell still have malpractice insurance? Is there tail coverage?
- There’s another case mentioned where they will have to pay $500,000 but it doesn’t mention specifics of plaintiffs, etc.
- A case involving a suit by Brenda Leonhardt appears to be pending based on the SEC document.
What is US Stem doing now? Comella?
Overall, this firm is likely to remain in the news for years to come even if they aren’t involved anymore in stem cell clinic offerings.
Their website lists some other efforts including one related to a 2009 IND. I’m not clear on the status of this clinical program. For example, one called Myocell, when searched on Clinicaltrials.gov, pulls up four results but they have “unknown” statuses. A search for another product, Adipocell, finds just one old completed trial with its last update being in 2009.
The SEC filing lists this staggering financial situation amid doubts about the company’s future: “As of December 31, 2022, we have accumulated a deficit of approximately $139.8 million.”
Kristin Comella also had a new business incarnation as Regenerwave at one point, but it’s hard to tell what’s going on with it since the website isn’t working.
A four-month old YouTube interview with her suggests she’s still doing some kind of stem cell stuff. Maybe something outside the scope of the FDA lawsuit that led to a permanent injunction? Perhaps autologous bone marrow? New companies are mentioned.