Safety Study of Gene Therapy in Treating Critical Leg Ischemia

Summary

The purpose of this study is to determine the safety, tolerability and preliminary efficacy of intramuscular injections of VM202 for subjects with critical limb ischemia. Subjects selected for this study will have critical limb ischemia that has not responded to standard therapy with symptoms including pain at rest and/or ischemic ulcers.

Timeline

Start

2007-04-03

Primary completion

2009-10-19

Completion

2023-12-11

Publications

• Background Henry TD, Hirsch AT, Goldman J, Wang YL, Lips DL, McMillan WD, Duval S, Biggs TA, Keo HH. Safety of a non-viral plasmid-encoding dual isoforms of hepatocyte growth factor in critical limb ischemia patients: a phase I study. Gene Ther. 2011 Aug;18(8):788-94. doi: 10.1038/gt.2011.21. Epub 2011 Mar 24.

Drugs

Indications