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July 18, 1990

Human Gene Therapy in Coming Months?

JAMA. 1990;264(3):314-317. doi:10.1001/jama.1990.03450030028007

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AFTER EARLIER critical reviews, the green light is burning brightly for the first clinical trial of true gene therapy.

If all goes according to a plan developed by the Human Gene Therapy Subcommittee, the study is likely to start in the fall. The main hurdles are expected to have been jumped by the end of this month, when the subcommittee meets again.

The subcommittee's parent body, the Recombinant DNA Advisory Committee, is meeting at the same time (July 30) and is expected to approve the subcommittee's recommendation then and there. The study still will require approval by the Food and Drug Administration and also will have to be approved by the acting director of the National Institutes of Health, William Raub, PhD.

The study, which will be done at the National Institute of Health's Clinical Center by W. French Anderson, MD, of the National Heart, Lung, and Blood Institute, and