January 24, 2021

The Niche

Trusted stem cell blog & resources

US Stem Cell

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

2 min read

The last few years for the publicly-traded stem cell clinic biz, US Stem Cell, Inc., which goes by the ticker $USRM, have seemed like a rollercoaster to me as an observer. I can see four main areas of news that to me make the future seem uncertain for this firm. First, the US Stem was linked to the alleged blinding of some of its customers in 2016, faced two lawsuits (now settled) on that front, and now has to deal with a third lawsuit. Second, probably in part …Read More

6 min read

FDA Commissioner Scott Gottlieb and CBER Director, Peter Marks, have just published a new piece on stem cells and regenerative medicine in the New England Journal of Medicine (NEJM). What are the core points here and what can we learn from reading between the lines a bit? There are some expected things and then some surprises. The title of the article is “Balancing Safety and Innovation for Cell-Based Regenerative Medicine,” which really gets to the heart of what I think the FDA is trying …Read More

8 min read

When I read about a stem cell penis growth injection, what comes to mind first when you read that is “Ow!” When a guy willingly has anything injected down there, maybe you’d think that there would be a compelling medical reason such as erectile dysfunction to do so as it seems risky or painful? But the news that the publicly-traded stem cell clinic biz US Stem Cell, Inc. ($USRM) injected some guy’s penis with fat stem cells to attempt to make it bigger when …Read More

7 min read

When you think of Florida, what else crosses your mind first? Orange juice? Heat and humidity? Beaches? Disney? I don’t know if this says more about me or the state, but these days I think of stem cells. Florida and California are the two biggest hotbeds of the for-profit stem cell clinic world, each with a dizzying array of clinics, claims, alleged or confirmed patient injuries, and a feeling of chaos at times. You can see zoomed-in maps of Southern California and Florida clinics …Read More

3 min read

The FDA issued a historic statement today promising to more clearly define its regulatory policies on stem cell therapies and to take strong action on some stem cell clinics that it views as “bad actors”. I’ve never the FDA use such clear-cut language before. I give big kudos to new FDA Commissioner Scott Gottlieb. It already took some action too on clinics in Florida and in California. So today we heard about both a bold statement of vision on how the FDA will deal with …Read More

5 min read

Have more patients been blinded by stem cell clinics? The recent NEJM paper reporting on the blinding of three patients in Florida may be just the beginning of information beginning to flow on negative outcomes for patients who are customers of stem cell clinics selling non-FDA approved offerings. The NEJM authors linked the loss of vision to interventions received by patients from the publicly-traded company US Stem Cell, Inc., but different patients also in Florida have been alleging that they were blinded by a different entity, the “SCOTS trial”. I’ve …Read More

4 min read

Do 3 blinded stem cell clinic patients with major or complete vision loss constitute a significant adverse outcome? I would say so and a new paper details how this happened apparently at a particular publically-traded South Florida stem cell clinic business. You can see the damaged retinas of one such patient below in an image from a new NEJM paper reporting the severe adverse outcomes. The red areas are hemorrhaging with other substantial damage to the retina as well. How did this all happen? Last year the …Read More