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Vascular Medicine, Vol. 8, No. 1, 9-13 (2003)
DOI: 10.1191/1358863x03vm460oa

Adenoviral-mediated gene transfer of vascular endothelial growth factor in critical limb ischemia: safety results from a phase I trial

Emile R Mohler, III

Department of Internal Medicine, Section of Vascular Medicine, Division of Cardiology University of Pennsylvania Health System, Philadelphia, PA, USA, mohlere{at}uphs.upenn.edu

Sanjay Rajagopalan

Department of Internal Medicine, Section of Vascular Medicine, Division of Cardiology, University of Michigan Health System, Ann Arbor, MI, USA

Jeffrey W Olin

Department of Internal Medicine, Mount Sinai Medical Center, New York, NY, USA

Jeffrey D Trachtenberg

Decatur Memorial Hospital Cardiac and Vascular Research Institute, Decatur, IL, USA

Henrik Rasmussen

GenVec Inc., Gaithersburg, MD, USA

Raphael Pak

Pfizer Global Research & Development, Ann Arbor, MI, USA

Ronald G Crystal

Department of Internal Medicine, Cornell University, New York, NY, USA

Critical limb ischemia (CLI) is typifi ed by rest pain and/or tissue necrosis secondary to advanced peripheral arterial disease (PAD) and is characterized by diminution in limb per-fusion at rest. We tested the safety of an angiogenic strategy with CI-1023 (AdGV VEGF121.10), a replication-defi cient adenovirus encoding human vascular endothelial growth factor isoform 121 in patients with CLI as part of a phase I trial. Fifteen subjects >35 years of age with CLI and angiographic disease involving the infra-inguinal vessels underwent intramuscular injection of CI-1023 (4 3 108 to 4 3 1010 particle units, n = 13) or placebo (n = 2). All of the patients tolerated the injection well and there were no serious complications related to the procedure. Transient edema was noted in one patient. A total of 79 adverse events were reported over the course of one year. One death (day 136) and one malignancy (day 332) occurred in the CI-1023 group. CI-1023 appears to be well tolerated and safe for single-dose administration in patients with critical limb ischemia due to PAD. Further studies are needed to determine the efficacy of this form of therapeutic angiogenesis.

Key Words: angiogenesis • endothelium


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