August 7, 2020

The Niche

Knoepfler lab stem cell blog

SCOTS trial

5 min read

Could the blinding of three women at a stem cell clinic have been prevented by better oversight or was the clinic acting outside of the scope of oversight by its institutional review board (IRB)? More broadly, when is an IRB conducting proper oversight and how do we know? When on the other hand is it not being careful enough or even outright enabling risky behavior by those selling non-FDA-approved, experimental stem cell “treatments”? It can be hard to really be sure. What makes this area particularly muddled …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

3 min read

I’m hearing more questions from the community about alleged harm from stem cell clinics selling stem cells for a number of vision-related conditions and some concerns include the so-called SCOTS study. I first blogged about SCOTS early this year and back then I myself had questions too. Some commenters then raised concerns or questions about SCOTS in weighing in on that post. In my opinion SCOTS is almost certainly not a traditional FDA phased clinical trial, which raises issues right from the get go. I’m not aware …Read More

3 min read

Should we be injecting bone marrow cells into someone’s eyes? it seems like a terrible idea to me based on what we currently know. Whenever I see a stem cell headline like this one from a recent Baltimore Sun piece, it raises many questions: Stem cells apparently reverse woman’s blindness. First of all, is the reporter, Meredith Cohn in this case, being cautious enough with that “apparently” in the headline? Part of the reason for this question is that the “treatment” in question is unproven, …Read More