A new stem cell clinic lawsuit has popped up and this one, like some others, relates to a patient alleging vision loss due to a non-FDA approved stem cell offering and involves U.S. Stem Cell, Inc. (formerly called Bioheart).
American stem cell clinics market direct-to-consumer stem cell offerings for a whole medical dictionary’s worth of health conditions including vision loss. However, while stem cells have real promise for being the basis of future, safe and effective treatments for various forms of vision loss based on clinical trials run through the FDA and other similar international regulatory bodies, there is little if any concrete evidence that fat or bone marrow stem cells can be safely and effectively used for macular degeneration or other forms of vision loss right now.
In my opinion, offering stem cells outside the IND-based traditional FDA-related clinical trial process for vision loss is extremely risky, particularly when both eyes are injected at once, and has little if any chance of efficacy. Also, keep in mind that finalized FDA guidances now indicate that fat stem cells generally are...