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

Emile R. Mohler, Sanjay Rajagopaian, Jeffrey W. Olin, Jeffrey D. Trachtenberg, Henrik Rasmussen, Raphael Pak, Ronald G. Crystal

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59 Citations (Scopus)


Critical limb ischemia (CLI) is typified by rest pain and/or tissue necrosis secondary to advanced peripheral arterial disease (PAD) and is characterized by diminution in limb perfusion at rest. We tested the safety of an angiogenic strategy with CI-1023 (AdGVVEGF121.10), a replication-deficient 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 (4X 108 to 4 x 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.

Original languageEnglish
Pages (from-to)9-13
Number of pages5
JournalVascular Medicine
Issue number1
Publication statusPublished - 11 Jul 2003



  • Angiogenesis
  • Endothelium

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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