Move towards regulation of stem cell therapeutics

12 October 2009

Speaking at the recent World Stem Cell Summit, president of the International Society for Stem Cell Research (ISSCR) Irving Weissman reportedly announced that the creation of a new committee to regulate companies offering unproven stem cell therapies (see Nature news blog). The panel of lawyers, ethicists, stem cell scientists and representatives from the US Food and Drug Administration (FDA) have been discussing a web-based registry of companies that fail to comply with proposed measures to demonstrate credibility.

These measures, also set out in a recent publication in the journal Cell Stem Cell [Weissman I (2009) Cell Stem Cell. 5(2):151-3], would be citation of peer-reviewed literature supporting the therapy in question is theoretically possible; demonstration of institutional review board oversight of the treatment; and approval from the FDA or other equivalent national regulatory body.

The committee expects to produce a preliminary report by the end of the year, and formal guidelines early in 2010.

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