VEGF-2 for Critical Limb Ischemia: A phase 1-2, randomized, double-blind, placebo controlled dose escalating study of intramuscular vascular endothelial growth factor-2 (VEGF-2) Gene Therapy in Patients with Moderate or High Risk Critical Limb Ischemia

Study of:
Vascular endothelial growth factor-2 (VEGF-2)

Critical limb ischemia (CLI) is a severe manifestation of peripheral artery disease that can necessitate partial or complete amputation of the affected limb (usually a leg). CLI is characterized by persistent ischemic rest pain in the affected limb and is often accompanied by skin ulceration that does not improve without clinical intervention. The diminished healing ability and persistent or recurring limb pain are due to chronic decreased blood circulation to the limb, typically resulting from atherosclerosis. This gene therapy study is for patients with critical limb ischemia. In this study patients will have each received a given dose (2 or 8 mg pVGI.1) or placebo. No viral vectors or liposomes will be used to deliver the above-described plasma.

Since this is an early phase study, there may be no benefit to the patient. If new blood vessels grow, it is possible that the flow of blood to the leg muscles may improve and possibly improve claudication symptoms. This study allows patients ages 21 and older to participate. Patients with Buerger’s Disease will be allowed to participate in this study. If subjects are randomized to receive placebo (salt water), and their rest pain and/or ulcers do not improve or become worse, subjects will have the opportunity to “crossover” to the treatment arm of the study and receive injection of the study agent, VGEF-2 DNA. Gene transfer will occur after the patient has completed 6 months of the study.

• Timothy D. Henry, MD, FACC

• Alan T. Hirsch, MD, FACC
• Daniel Lips, MD, FACC
• Yale Wang, MD, FACC, FSCAI

• JoAnne Goldman, RTR, RCIS, CCRC
• Vicki R. Pink, RN, CCRC

For more information about this study or the Cardiovascular Research program at the Minneapolis Heart Institute Foundation, please contact Vicki Pink, RN at 612-863-6286.