title: Therapeutic angiogenesis for critical limb ischemia: design of the hepatocyte growth factor therapeutic angiogenesis clinical trial.
abstract: 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 perfusion 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.
authors.affiliation: Division of Vascular Surgery, Department of Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA. Richard.J.Powell@Hitchcock.org
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Powell
authors.forename: John
authors.initials: J
authors.lastname: Dormandy
authors.forename: Michael
authors.initials: M
authors.lastname: Simons
authors.forename: Ryuichi
authors.initials: R
authors.lastname: Morishita
authors.forename: Brian H
authors.initials: BH
authors.lastname: Annex
mesh_terms: D000328:Adult; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D017228:Hepatocyte Growth Factor / Q000097:blood / Q000627:therapeutic use; D006801:Humans; D007511:Ischemia / Q000503:physiopathology / Q000628:therapy*; D035002:Lower Extremity / Q000098:blood supply* / Q000503:physiopathology; D008297:Male; D018919:Neovascularization, Physiologic; D016491:Peripheral Vascular Diseases / Q000628:therapy; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012039:Regional Blood Flow; D012107:Research Design; D016896:Treatment Outcome
chemical_list: D017228:Hepatocyte Growth Factor