Do three blinded US 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 story began to break of multiple patients alleging they had been blinded by different businesses in South Florida. Dr. Thomas Albini presented on some information on this at the FDA meeting last fall, but things weren’t entirely clear. Back then there were also indications of lawsuits by patients related to alleged vision loss due to experimental stem cell offerings against various parties involved.
Now we have more details on some of the cases in this new NEJM article (Kuriyan, et al.) in which the authors attribute these patients’ experiences to a withdrawn “trial”, NCT02024269, which lists Bioheart (now known as US Stem Cell, Inc.) as the sponsor. I put “trial” in quotes because it was withdrawn and also because as best as I can tell this wasn’t a traditional FDA-approved trial of the kind normally based on pre-clinical data and an IND. US Stem Cell, Inc. is a publicly-traded company ($USRM) and its stock has been all over the place this year. I’m not aware of US Stem Cell having FDA approval for what it is doing.
The NEJM article oddly does not mention Bioheart or US Stem Cell, Inc. by name as the place where the patients were given the stem cells, but the authors do clearly link them together and other information further supports this connection.
For example, US Stem Cell, Inc. leader Kristin Comella acknowledged last year in an NPR interview that two of their patients had retinal detachment following interventions received from the company. From NPR:
“Comella acknowledges that two of her clinic’s patients suffered detached retinas after getting stem cells injected into their eyes. As a result, the clinic has stopped treating eye conditions.”
You can read my 2015 interview with Comella here. I have reached out to her more recently to ask for her perspectives on the situation with these patients, but gotten no reply.
The NEJM article goes through the cases of the three blinded stem cell clinic patients who had received adipose stem cell injections into their eyes:
“We report three cases of vision loss after patients with AMD received bilateral intravitreal injections of autologous adipose tissue-derived stem cells at a stem-cell clinic, which was the study site for the fourth trial described above (NCT02024269). After treatment, in June 2015, the patients were referred to two university-based ophthalmology practices.”
There are so many questions here.
Why would someone think that fat stem cells could be used safely and effectively in eyes? To me as a stem cell biologist that doesn’t make sense.
Why would an IRB approve this kind of risky approach?
Why did they inject into both eyes at once?
And a biggie: if preclinical testing had been done and rodents had been given equivalent transplants, would some of the animals have gone blind? If so, could that have prevented this tragedy?
Since US Stem Cell, through a subsidiary called US Stem Cell Training, sells some kind of stem cell training to others to do stem cell interventions, is that spreading risks to patients even further? Notably on the US Stem Cell Training website none of the personnel listed as doing the stem cell clinical training are MDs. Why is that?
Is this just the tip of the iceberg for negative stem cell clinic outcomes given that there are around 600 such clinics in the US today largely operating generally without FDA approvals, lacking preclinical data to support what they are doing, and experimenting on thousands of patients for profit?
Where was the FDA in all of this and are they doing anything about it now?
In the same issue of NEJM there’s an opinion piece by top stem cell researcher and Harvard Med School Dean George Q. Daley comparing this unfortunate situation to the very different stem cell clinical research done in a 2nd paper (also published in the same issue and about which I will blog in coming days if I have time) that he sees by contrast as having been done in a responsible way.
South Florida seems to be a risky hotbed of stem cell clinics and beyond US Stem Cell, another non-FDA approved vision stem cell study there called the “SCOTS trial” has been controversial as well with a number of patients alleging they were blinded.
The clinicaltrials.gov website remains a great, but also very problematic resource. Many patients seem to view anything listed on there as a legitimate, NIH-approved full-blown clinical trial and some clinics encourage that view, but that’s clearly not the case. I interviewed the leader of clinicaltrials.gov in 2014 and problems were already apparent to me back then from that discussion. Clinicaltrials.gov needs to provide patients with much more information (e.g. IND status, fee as inclusion criteria, etc.) and consider excluding certain listings. While it is quite possible that it lacks the budget, the flexibility, and/or the authority to make such changes quickly, a lot is at stake. They need to make changes asap.
I hope that the NEJM paper on the 3 patients will raise awareness and spark meaningful actions to protect stem cell clinic patients moving forward.