cell therapy

No Increased Cancer Risk from Your Autologous BMC Treatment

In the previous post, I commented on a paper recently published in the New England Journal of Medicine (NEJM) in which FDA personnel expressed their dissatisfaction with the lack of solid, Level 1 clinical trials for the use of stem cell therapies. Their concern quite naturally was on the lack of systematic recording of adverse...
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Cell Therapy

FDA’s Broadside Against Cell Therapy

The New England Journal of Medicine recently published an article written by folks at the FDA on science-based approaches to regulating the apparently confusing world of stem cell therapy (View Article). The focus of the article was on describing how the FDA views “stem-cell (sic) therapy”: “Often, these cells (whether derived from autologous or allogeneic...
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