US to enter the fray on mitochondrial replacement

10 October 2013

The U.S. Food and Drug Administration is examining the modification of human egg cells as part of in vitro fertilisation (IVF) to prevent mitochondrial disease or counter infertility.
 
The Cellular, Tissue and Gene Therapies Advisory Committee is due to meet on 22-23 October, though presumably the government shutdown may delay this.
 
US scientists reportedly say they are ready to move to human trials of the technique, which would require regulatory approval from the FDA.  The UK regulator has already given theoretical assent, and has set in motion changes to the law that will be necessary to legalise its use in humans, though legal and ethical objections have been raised (see previous news).
 
The committee is also to consider issues relating to the design of early-phase clinical trials for cellular and gene therapy products.  

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