FRIDAY 17th OCTOBER 2003
National Institutes of Health
Recombinant DNA Advisory Committee (RAC)
93rd Meeting of the NIH RAC
Bethesda Marriott Hotel
October 17, 2003
8:30 AM Call to Order and Opening Remarks
Theodore Friedmann, M.D., Chair, NIH RAC
8:35 AM Powerpoint Slides
Discussion of Human Gene Transfer Protocol #0307-593 entitled:
A Phase I Open-label Safety Study of Intrastriatal Infusion of Adeno-Associated Virus Encoding Human Aromatic L-amino acid
Decarboxylase (AAV-hAADC-2) in Subjects With Advanced Parkinson's Disease [AAV-hAADC-2-003]
PI: Michael Aminoff, M.D., D.Sc., University of California, San Francisco
RAC Reviewers: Philip Johnson, M.D.
Martha Bohn, Ph.D.
Madison Powers, J.D., D. Phil.
Ad Hoc Reviewer: D. Eugene Redmond, Jr.,M.D., Yale University,
Tab 2314 Protocol
Tab 2315 OBA Summary
OBA Letter to PI on In-depth RAC Review and Public
Outcome of Initial Review by RAC Members
Reviews from Drs. P. Johnson, Bohn, Powers, and Redmond,