This is why America has fallen behind and missed the bus in stem cell research... On an MS stem cell clinical trial that just gained approval in the US: Although the study was initially approved by the International Cellular Medicine Society (ICMS), which is an Institutional Review Board (IRB), in November 2011, it had been delayed due to regulatory issues. Last September, the FDA advised Tisch “that a clinical trial of stem cell therapy falls under FDA jurisdiction as an Investigational New Drug (IND), and that therefore IRB approval in the absence of additional FDA-IND approval is not a sufficient legal basis for initiating the stem cell trial.” All work on the stem cell trial was suspended at that time until the regulatory issues were resolved and the FDA granted this approval. Notice the words risky, unsafe, untested, etc. were not in the FDAs explanation for why the trial was blocked in 2011. It was simply not a sufficient legal basis until the regulatory issues were resolved. Meanwhile, the FDA approved a new MS drug that has already killed one person. At least theyre going forward with it.
Posted on: Tue, 23 Dec 2014 21:42:03 +0000
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