David J. Margolis, M.D. MSCE is currently Associate Professor of Dermatology, an Associate Professor of Epidemiology in the Department of Biostatistics and Epidemiology, and Senior Scholar (core faculty member) in the Center for Clinical Epidemiology and Biostatistics of the University of Pennsylvania. He is a patient-oriented researcher with a track record of research. His research has been focused on the prevention and treatment of chronic wounds. He has applied a variety of epidemlologic tools and patient-oriented research methods to address research issues. His immediate and long-term career goals center on his desire and intention to continue to evolve and mature as a patient-oriented researcher, teacher, and mentor. Resources available to him, on and around the Penn campus, include biostatistical support, data management support, and research/clinical laboratory services. The proposed patient-oriented NAIMS-funded research project is in its first of five years. Most patients with chronic wounds of the lower extremity fail to heal in a reasonable period of time. In fact, despite considerable advances in elucidating the molecular basis of wound repair, attempts at developing new therapies have been disappointing. Current methods of applying cytokines to chronic wounds are inadequate. The PI hypothesize that a growth factor associated with wound healing PDGF-BB, when produced in large quantities within the wound bed due to adenovirus-mediated gene overexpression by the cells of the wound bed, will dramatically enhance wound healing. This study will use a gene therapy approach, adenovirus-Ad5 and the PDGF-B gene, to insure delivery of a cytokine growth factor to a non-healing wound.
The aim of the research study is to assess local and systemic toxicity, and the biologic feasibility of using the maximum tolerated dose of H5.020CMVPDGF-B associated with in vivo PDGF-BB gene transduction via an intra-ulcer injection of H5.020CMVPDGF-B in patients with chronic venous leg ulcers. This study is a collaborative effort between investigators from the University of Pennsylvania Medical Center (Dermatology and Institute for Human Gene Therapy), the Wistar Institute, and the Children's Hospital of Philadelphia.
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