A Phase 3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AMG0001 in Subjects with Critical Limb Ischemia
A study for people with leg pain or/and non-healing wounds who have no surgical solution for their vascular problems
Sponsor: AnGes
Enrolling: Male and Female Patients
Study Length: 19 Months
Clinic Visits: 20
IRB Number: AAAN8456
U.S. Govt. ID: NCT02144610
Contact: Diana Catz: 212-342-4102 / dsc6@cumc.columbia.edu
Additional Study Information: The purpose of this study is see if an experimental gene product, the Hepatocyte Growth Factor (HGF) Plasmid (AMG0001) which will be injected into the affected leg's muscles is effective in treating the blockages in your leg without causing adverse effects. Affected leg means the leg that has the severest disease relating to the blockage or narrowing of the arteries in the leg. The HGF plasmid hopefully will help your body to create new vessels in your leg and alleviate the symptoms of lack of circulation such as healing your wounds. You will need to visit the clinic about 20 times during this 19-month study, but we will help with transportation expenses.
This study is closed
Investigator
Roman Nowygrod, MD
Do You Qualify?
Do you have severe renal disease? Yes No
Are you a woman of childbearing potential? Yes No
Did you ever received an organ transplant? Yes No
Are you receiving chemo or radiation therapy? Yes No
Do you have liver disease such as Hepatitis B or C or cirrhosis of the liver? Yes No
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For more information, please contact:
Diana Catz
dsc6@cumc.columbia.edu
212-342-4102
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