Clinical Protocol: Phase I trial to evaluate the safety of H5.020CMV.PDGF-B for the treatment of a diabetic insensate foot ulcer

Most patients with chronic wounds fail to heal in a reasonable period of time. Despite considerable advances in elucidating the molecular basis of wound repair, attempts at developing new therapies have been disappointing. In fact, in the few studies where cytokine growth factors have been efficacious, their effect has been dramatically less than would have been predicted from animal studies. We hypothesize that platelet-derived growth factor-BE, a growth factor associated with wound healing, 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. Simply stated, we plan to insure the delivery of the growth factor by using gene therapy techniques so that cells locally involved in the wound healing process will temporarily increase their production of platelet-derived growth factor-BE. We present the first step in the series of human investigations to test this hypothesis which is a phase I clinical trial, Our proposed study is designed to assess local and systemic toxicity, and the feasibility of using the maximum tolerated dose of H5.020CMV.PDGF-b associated with in vivo platelet-derived growth factor-BE gene transduction via an intraulcer injection of H5.020CMV.PDGF-b in patients with a diabetic insensate foot ulcer.