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Vascular Medicine, Vol. 9, No. 3, 193-198 (2004)
DOI: 10.1191/1358863x04vm557oa

Therapeutic angiogenesis for critical limb ischemia: design of the hepatocyte growth factor therapeutic angiogenesis clinical trial

Richard J Powell

Division of Vascular Surgery, Department of Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA, Richard.J.Powell{at}Hitchcock.org

John Dormandy

Division of Vascular Surgery, St George’s Hospital, London, UK

Michael Simons

Division of Cardiology, Department of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA

Ryuichi Morishita

Division of Clinical Gene Therapy, School of Medicine, Osaka University, Japan

Brian H Annex

Division of Cardiology, Department of Medicine, Durham VA and Duke University Medical Center, Durham, NC, USA

The objective of the HGF-STAT clinical trial is to determine whether perfusion can be improved by gene transfer with a plasmid DNA containing hepatocyte growth factor (HGF) in the affected limb of patients with unreconstructable critical limb ischemia (CLI). CLI results in a high rate of limb loss and impaired quality of life. The current therapeutic strategies, including bypass surgery and percutaneous interventions, are only successful in treating a subset of patients. Therapeutic angiogenesis is an investigational method that seeks to favorably impact tissue per-fusion in CLI. HGF-STAT is a double-blind, parallel-group, placebo-controlled, dose response study in 100 patients with unreconstructable CLI. Eligible subjects will be randomized 1:1:1:1 to receive saline placebo or one of three dose/regimens of HGF plasmid DNA. The selection of outcome measures, including the primary endpoint, and changes in transcutaneous oxygen pressure (TcPO2) from baseline to 3 months will be discussed. In conclusion, this study will help to determine whether therapeutic angiogenesis with HGF is a viable option in the treatment of patients with CLI.

Key Words: angiogenesis therapy • critical limb ischemia • gene transfer • vascular surgery


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