WIKIPEDIA, TMHLEEThree women were blinded following a procedure involving the injection of adipose-derived stem cells into their eyes, according to a report in the New England Journal of Medicine today (March 16). The patients were looking for a treatment to abate age-related macular degeneration, but within days of the experimental therapy they suffered severe complications.
Such stem cell treatments—when taken from the patients’ own bodies—are largely unregulated by the US Food and Drug Administration, and also largely unproven. “There is little question that when the FDA is involved in regulatory oversight, it works in favor of patient safety,” Stanford University’s Jeffrey Goldberg, a coauthor of the paper, told STAT News. “That would have protected patients in cases like these.”
According to Kaiser Health News, a Florida-based company formerly known as Bioheart Inc. and now called U.S. Stem Cell, sponsored the experimental treatment, which the firm had listed on clinicaltrials.gov, featuring the stem-cell procedure. But there were serious flaws, according to Goldberg’s report, including a lack of safety data.
“Is this just the tip of the iceberg for negative stem cell ...
