Study of HGF Via Plasmid Vector to Improve Perfusion in Critical Limb Ischemia

Completed · Phase 2

Conditions studied: Arterial Occlusive Disease, Peripheral Vascular Disease, Ischemia

In brief

The primary purpose of this study was to assess the overall safety of different dose regimens of AMG0001 (HGF transferred via plasmid vector) as well as evaluate the improvement of blood perfusion in subjects with critical limb ischemia (CLI). This study also evaluated the improvement in wound healing without adverse effects on the quality of life, as well as the potential reduction of amputation, mortality and rest pain in the CLI population.

Key facts

Study ID

NCT00060892

Run by

AnGes USA, Inc.

People needed

104

Starts

2003-04-01

Expected to finish

2007-01-01

Last updated by the study team

2008-01-11

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects will have one or more clinical indications diagnostic of CLI such as: distal extremity pain at rest that requires the subject to use analgesics for >2 weeks; or peripheral ischemic ulcer(s); or areas of gangrene.
• The subject will have a TcPO2 of </= 40 mmHg.
• Subjects will have one or both of the following hemodynamic indicators of severe peripheral arterial occlusive disease: (a) Ankle systolic pressure of </= 70 mmHg; (b)Toe systolic pressure </= 50 mmHg.
• The subject is a poor candidate for standard revascularization treatment options for peripheral arterial disease, based on inadequate bypass conduit, unfavorable anatomy, or poor operative risk.
• Subject has signed an informed consent form either directly or through a legally authorized representative
• If female, the subject must be (a) at least one year post-menopausal, or (b) surgically sterile, or (c) if the subject is of child-bearing potential, she must have been practicing contraception for at least 12 weeks prior to entering the study.
• If subject is of reproductive potential, he or she must be using an accepted and effective (barrier) form of birth control during the study.
• Subjects will be on a statin and an anti-platelet agent as part of their standard of care and must be stable on these regimens for at least 4 weeks prior to treatment.

You may not qualify if…

• Subjects, who in the opinion of the investigator, have a vascular disease prognosis that indicates they would require a major amputation (at or above the ankle) within 4 weeks of start of treatment.
• Subjects with a diagnosis of Buerger's disease (Thromboangitis Obliterans).
• Subjects with hemodynamically significant aorto-iliac occlusive disease.
• Subjects who have had a revascularization procedure within 12 weeks prior to treatment initiation that remains patent. Revascularization procedures that are evidenced to have failed for >2 weeks prior to treatment initiation are acceptable.
• Subjects who require a change in their hypertension medication as part of their standard of care within 4 weeks prior to treatment.
• Evidence or history of malignant neoplasm (clinical, laboratory or imaging), except for basal cell carcinoma of the skin.
• Subjects who have proliferative diabetic retinopathy or severe, non-proliferative retinopathy
• Subjects with end stage renal disease (ESRD) defined as significant renal dysfunction evidenced by a creatinine of > 2.5, or receiving chronic hemodialysis therapy.
• A subject who has hepatic cirrhosis, viral hepatitis, or is HIV positive.
• Subjects with a clinically significant liver enzyme abnormality (i.e., AST or ALT more than two times the upper limit of normal and/or bilirubin more than 50% the upper limit of normal).
• Subjects requiring the use of hyperbaric oxygen treatment for wound healing during the screening and 6 month follow-up period.

Where it is running

• Cardiology, P.C. — Birmingham, Alabama, United States
• Central Arkansas Veteran's Healthcare System — Little Rock, Arkansas, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Falk Cardiovascular Research Center — Stanford, California, United States
• VA Medical Center Surgical Service (112) — Washington D.C., District of Columbia, United States
• Basptist Hospital — Pensacola, Florida, United States
• University of South Florida College of Medicine — Tampa, Florida, United States
• American Cardiovascular Research Institute — Atlanta, Georgia, United States
• University of Chicago Hospitals — Chicago, Illinois, United States
• The Care Group, LLC — Indianapolis, Indiana, United States
• The Ochsner Heart and Vascular Institute — Metairie, Louisiana, United States
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
• Dartmouth - Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Diabetes Foot and Ankle Center — New York, New York, United States
• NYPH-NY Weill Cornell Medical Center — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• Pitt County Memorial Hospital — Greenville, North Carolina, United States
• The Lindner Clinical Trial Center — Cincinnati, Ohio, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Jobst Vascular Center — Toledo, Ohio, United States
• Medical College of Ohio — Toledo, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Baylor College of Medicine — Houston, Texas, United States
• Peripheral Vascular Associates — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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