Trial Information

Summary: A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-Selection Study of Ad2/Hypoxia Inducible Factor (HIF)-1a/VP 16 in patients with intermittent claudication

The purpose of this study is to look at the safety and potential effect of a study drug named Ad2/HIF-1a/VP16. This study drug will be given to muscles in each of your legs through multiple injections at one visit, to see if it can make new blood vessels grow from existing blood vessels in your leg. This process of growing new blood vessels is called angiogenesis. Because a gene is delivered to your body by Ad2/HIF 1a/VP16, this method is called gene transfer.

This study will involve evaluating a total of 300 people between The Mount Sinai Medical Center and approximately 35 medical centers throughout the United States and Europe. The Mount Sinai Medical Center expects to enroll approximatley 30 patients.

The screening visits include cancer screening exams, physical examination, blood pressure readings in your arms and ankles, ultrasound of your legs, chest x-ray, eye examination, and a walking treadmill test. If you qualify after the screening visits, there will be 9 follow-up visits. The visits include physical examinations. The tests will include blood pressure readings in your arms and ankles, blood drawing, walking treadmill tests, and questionnaires.
Compensation Provided

Patient Inclusion/Exclusion Criteria:

1.Males and females 40 to 80 years of age
2.Diagnosis of peripheral arterial disease in both lower limbs, present for at least 6 months.

1.Patients with leg pain at rest
2. Patients who have immunological or inflammatory disorders such as Buerger's Disease.
3.Patients who have had surgical revascularization in the legs within 6 months
4.Patients whom walking impairment due to pain in the legs is the result of other conditions such as severe peripheral nerve pain, back disorders
5.Presence or history of cancer within 5 years.
6.Patients with diabetic retinopathy or wet AMD
7. Diabetes type 1 (juvenile onset)
8. Poorly controlled type 2 diabetes
9.Active hepatitis or other current infectious disease
10. Patients with other comorbities such as severe congestive heart failure, heart attack within 4 weeks, stroke within 3 months, severe chronic obstructive pulmonary disease, undergoing hemodialysis, organ transplant recipient, alzheimer's disease
11.Women who are pregnant or breast feeding will be excluded from this study. Women of childbearing age in this study need to use all means available to prevent themselves from becoming pregnant. Some methods include abstinence, diaphragms, condoms, birth control pills or injectable contraceptive drugs.
12.Fertile men who are not willing to use barrier-type contraception

If you would like to learn more about participating in this study, please send an e-mail message using the form below.