What can go wrong with unapproved stem cell clinics? The answer including from presentations at the FDA today turns out to be very serious, negative results right here in the U.S.
Thomas Albini, MD gave a talk entitled, “Severe Visual Loss After Intravitreal Injection of Autologous Adipose Tissue-derived Stem Cells for Age-related Macular Degeneration”.
Stem cell clinic transplants of fat stem cells led to blindness in three women, reported Dr. Albini.
We’ve heard encouraging news about how stem cells might help patients regain lost vision or preserve existing vision in the face of a disease like macular degeneration in the future. There’s real potential there with rigorous clinical trials that are ongoing.
Here in this very different case we heard from Dr. Albini about how stem cells inappropriately used by a stem cell clinic in South Florida reportedly caused 3 women to go blind. All had retinal detachment potentially, Dr. Albini said, due to the fat stem cells taking up residence and resulting in pulling of the eye tissue internally. A nurse practitioner reportedly did the transplants rather than a physician. The patients assumed, we were told in the talk, that the listing in clinicaltrials.gov of the “trial” meant the interventions were legit.
This is such a deeply tragic case we can only hope that more people aren’t blinded from this kind of stem cell clinic offering. More on this situation here at Nature by Heidi Ledford.
Michael Miller, MD, PhD, spoke next with his talk entitled, “Glioproliferative Lesion of the Spinal cord Arising from Exogenous Stem Cells.” This case already has had quite a lot of media attention and involves stroke patient Jim Gass, who ended up with a large spinal tumor that dramatically negatively affected his health. We have to give Mr. Gass huge credit for having the courage to go public with this case. He got ES cells and allo MSCs both in China. Then he traveled to Argentina for autologous MSCs and then to Mexico where he got MSCs and neural stem cells. See image above from the talk. The spinal tumor had many weird features of various primitive tumors. It was clearly a malignancy. There were no major cancer-related mutations detected in the OncoPanel assay.
The bottom line. So when those promoting stem cell clinics or wanting much less oversight ask “what can go wrong?” and they don’t really believe much can go wrong, we now know for sure that that view is just not accurate. Intensely bad stem cell clinic outcomes are occurring right here in the U.S.
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