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

Richard J. Powell, John Dormandy, Michael Simons, Ryuichi Morishita, Brian H. Annex

Research output: Contribution to journalArticle

28 Scopus citations

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 Rudy in 100 patients with unreconstructable CIL. 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.

Original languageEnglish (US)
Pages (from-to)193-198
Number of pages6
JournalVascular Medicine
Volume9
Issue number3
DOIs
StatePublished - Dec 1 2004
Externally publishedYes

Keywords

  • Angiogenesis therapy
  • Critical limb ischemia
  • Gene transfer
  • Vascular surgery

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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