AnGes - HGF Plasmid and Critical Limb Ischemia Treatment Study

Study of:
A hepatocyte growth factor (HGF)

The objective of this study is to increase the blood flow in the lower extremities, by creating the growth of new vessels for patients with critical limb ischemia through gene therapy. (Please choose the following link for more on gene therapy.) This is an angiogenesis study involving hepatocyte growth factor (HGF), a natural substance found in the body. Peripheral angiogenesis is considered a direct route to resolve critical limb ischemia. HGF’s properties are known to be involved in the growth and creation of new cells.

This study involves three different dosing groups, each group receives injections in the hamstring muscle four times each visit. This is done two to three times (depending on the specific dosing group) during the 35 day study trial.

The primary objective is to assess a change in the baseline TcPO2 at 3 months following the first treatment. The secondary objectives are an increase in limb salvage, improved wound healing, decreased rest pain, and increased quality of life.

• Timothy D. Henry, 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 other research studies at the Minneapolis Heart Institute and Minneapolis Heart Institute Foundation, please contact Vicki Pink at 612-863-6286.