U.S. Panel Recommends Limiting Gene Therapy Trials

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Halted U.S. experiments should resume for children with no other option, FDA advisers say.

Federal health advisers recommended late Friday that two U.S. gene therapy trials for children with a severe immune deficiency resume but on a very limited basis.

A Food and Drug Administration advisory panel said the two experiments should be allowed to continue only if the patients have exhausted other “reasonable alternatives,” including bone marrow transplants.

Otherwise, the panel suggested the trials—at the National Institutes of Health and the University of Southern California—remain suspended, the Baltimore Sun reported. Those trials, and another at USC, had been halted after a third child developed Leukemia in a similar French study.

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