Eye surgery image from Wikipedia. Is clinics injecting stem cells into an eye a good idea? OK with FDA?
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 of the trial having, for instance, an IND. Patients must pay $20,000 to participate and that brings additional questions.
The clinicaltrials.gov listing is here (reminder in general that a listing on that website does not equal FDA approval or some kind of NIH approval of the actual clinical science). The company mentioned as the responsible party is Retinal Associates of South Florida in collaboration with another business, MD Stem Cells.
A self-reported SCOTS study patient, George Gibson, made allegations to Scientific American that he lost vision after participating in the study:
“But not every story of stem cell therapy has such a rosy outcome. George Gibson was in his late 60s when he partially lost his vision during heart surgery. He says he paid $20,000 to get stem cells injected into his eye with the guarantee that he would be able to read a few more lines on an eye chart. Gibson claims that instead, he lost vision in that eye completely, but his assertions could not be verified. There have been other reports of vision loss in stem cell procedures performed elsewhere. Gibson didn’t get one of the first-come-first-serve slots to speak at the hearing; instead, he and his wife stood outside the meeting room during breaks with big signs that read, “I lost my sight to the SCOTS stem cell procedure!!!”
To be clear, this outcome has not been independently verified and the SCOTS investigators dispute the allegation.
Another SCOTS patient, Doug Oliver, who has also commented on this blog, has apparently had the opposite kind of experience. He self-reported a very striking positive outcome after receiving the stem cells in SCOTS and this has gotten a lot of media attention.
Two case report publications are listed as associated with the SCOTS study:
So what is going on here?
The short answer is that we as a community don’t know yet.
In a number of different stem cell studies over the years we’ve heard about individual patients having striking outcomes. Anecdotal reports of alleged potential harm or benefit should definitely be paid attention to and given consideration, but what we really need is comprehensive data from properly controlled studies to have confidence that an investigational stem cell therapy is (or is not) safe and effective.
Related to this specific study, I’m very happy for Doug, but the SCOTS study needs to show/publish all the data including any potential adverse outcomes before we can know what is going on with this investigational treatment. Last week I emailed Dr. Steven Levy, MD who is running the study asking if I could do a brief email Q&A with him for the blog, but so far no reply. Dr. Jeffrey Weiss is listed as the Principal Investigator so I may reach out to him as well if I don’t hear from Dr. Levy.