In the United States, three women aged 72, 78 and 88 have lost their sight following stem cell injections in their eyes, in 2015, to treat ARMD. This resulted in “a gradual and irreversible loss of vision”. The injections “were administered as part of a pseudo-study conducted in a Florida Clinic, US Stem Cell, without FDA approval”.
This case highlights controversial but common practices of “stem cell clinics” in the United States. These clinics treat patients “without proof of efficacy and with poor supervision, promising miracles”. In the recently condemned case, the pseudo-study had been registered on the ClinicalTrials.gov site but figures should have alerted patients. They had to pay €5,000 for the procedure and the stem cells taken from fatty tissue were injected in both eyes at the same time, “which is a rare and risky procedure”. In fact, one year on from the injection, “their vision had deteriorated far more than it would have done after one year of conventional ARMD treatment”.
The FDA has repeated its warning about “stem cell clinics”, denouncing“stem cell concepts with no scientific proof “, e.g. “the idea that stem cells injected in a given area will automatically differentiate themselves to repair the damaged areas”. They“are pointing fingers at excessive expectations” regarding stem cells.