This Program Project Grant application (PPG) seek funding for a Program of Excellence in Gene Therapy (PEGT) at St. Elizabeth's Medical Center (SEMC)/Tufts University School of Medicine Center, George Washington University, Rockville, MD. The PPG consists of three Clinical Projects and two Pre-clinical Projects, supported by four Cores. Dr. Jeffrey M. Isner, Principal Investigator (P.I.) with overall responsibility for the PPG, will serve as Project Director for (clinical) Project 1, """"""""VEGF Gene Transfer for Diabetic Neuropathy."""""""" Dr. Douglas Losordo will direct (clinical) Project 2, """"""""VEGF Gene Transfer to Prevent Coronary Artery Restonosis."""""""" (Clinical) Project 3, """"""""VEGF Gene Transfer to Promote Angiogenesis in Patients with Advanced Heart Failure, will be directed by Dr. Patrick McCarthy, Surgical Director of the Cleveland Clinic Kaufman Center for Heart Failure."""""""" Dr. Takayuki Asahara will direct (pre-clinical) Project 5, """"""""Endothelial Progenitor Cell Gene Transfer."""""""" The research productivity and functional capacity of the PPG will enhanced by four Cores, the Plasmid Core, will provide clinical grade plasmid DNA vector, and will be supervised by administrative assistance. Drs, Losordo and Walsh will also direct the Training Core. Core, the Data Management Core, directed by Kathryn Hirst, PhD. Research Associate Professor of the Biostatistics Center, George Washington University will assist with data management and analysis, and will also ensure compliance with all appropriate regulatory bodies. The studies and organization outlined in this PPG are intended to provide high quality and credible clinical as well as pre-clinical research studies of gene transfer that will represent meaningful contributions to both the scientific community and lay public.
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