658. Development and Evaluation of an Infusion Device for AAV-Mediated Gene Delivery to the Brain

A custom infusion device was developed for delivery of recombinant AAV2 to human putamen in a phase I/II clinical trial for treatment of Parkinson's disease. The device was designed to 1) minimize vector loss to the internal surfaces of the cannula and tubing, 2) minimize the hold-up volume of the device such that vector could be dispensed efficiently from a syringe placed approximately four feet away from the site of infusion, 3) attach to a commonly used stereotactic surgical frame, 4) connect to a programmable syringe pump, and 5) allow manufacturing in compliance with quality system requirements (QSR) for medical devices.