Study links 3 blinded patients to irresponsibly conducted experimental stem cell therapy

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Stem cell clinic therapy leads to loss of vision of 3 patients.

A recent study published in a reputable medical journal reports major or complete loss of vision in 3 patients at a particular publicly-traded South Florida stem cell clinic business due to experimental stem cell offerings. This comes after multiple patients alleged last year they had been blinded by different businesses in South Florida.

stem cells eyes
Damaged retinas of one of the patients. The red areas are hemorrhaging with other substantial damage to the retina as well. Image Source : Kuriyan, et al. 2017 NEJM Figure 2A

These observations by Jeffrey L. Goldberg were published in NEJM in their March 16 edition. The authors have attributed these adverse experiences to a withdrawn “trial”, NCT02024269, which lists Bioheart (now known as US Stem Cell, Inc.) as the sponsor.

“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.”

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.”

This brings into light a number of concerns namely,

  • Why would someone think that fat stem cells could be used safely and effectively in eyes?
  • Why would an IRB approve this kind of risky approach?
  • Why did they inject into both eyes at once?
  • Where was the FDA in all of this and are they doing anything about it now?

Interestingly, the same issue of NEJM published another opinion article by George Q Daley, Harvard Medical School. He compared this unfortunate situation to an independent stem cell clinical research done in another paper published in the same issue.

“In stark contrast to the care and prudence exercised by Mandai et al. is the careless treatment of AMD in three elderly women who received intravitreal injections of a poorly defined slurry of autologous adipose tissue–derived cells in both eyes, as described by Kuriyan et al.,” says Daley and adds further “Kuriyan et al. describe how such interventions were highly injurious, resulting in the induction of blindness in one woman and marked visual loss in the other two women. This report joins a small but growing medical literature highlighting the risks of such wanton misapplication of cellular therapy.

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.

Although stem cells represent new therapeutic strategies to repair and regenerate tissues damaged by disease or injury, much remains to be learned about how stem cells and their derivatives can be manufactured and delivered safely to integrate into existing tissue architecture and restore function.

Hopefully, this NEJM paper on the 3 patients will raise awareness and spark meaningful actions to protect stem cell clinic patients moving forward.