Here’s an informative article from h+ magazine on how the FDA currently argues that culturing adult stem cells amounts to the creation of a new drug. This of course would mean long time lags for getting stem cell procedures approved, which has prompted the creation of at least two groups: the American Stem Cell Therapy Association (ASCTA) and Safe Stem Cells NOW! (both focused on adult stem cells).
It doesn’t make sense to me that my own cells would be considered a “drug,” but Dr. Christopher J. Centeno who was interviewed for this article by Stephen Coles says that “The FDA is working to protect the interests of Big Pharma.” Yikes — if that’s the case, it’s a huge setback for personalized medicine.
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