Safety Study of MultiGeneAngio in Patients With Peripheral Arterial Disease (PAD)

Exclusion Criteria

• •Presence of significant inflow disease \[defined as \>50% stenosis\] in the distal aorta, common or external iliac as assessed by conventional angiogram, digital subtraction angiography (DSA), or magnetic resonance angiography (MRA) performed \< 1 year prior to screening.
• •Critical limb ischemia, either chronic or acute ischemia manifested by rest pain, ulceration, or gangrene (Category 4 through 6 of Society for Vascular Surgery \[SVS\] classification \[Rutherford\]).
• •History of malignant neoplasm (except curable non-melanoma skin malignancies).
• •Renal failure (serum creatinine \>2.0 mg/dL) or end-stage renal disease(requiring hemodialysis or renal replacement therapy).
• •Significant hepatic disease (\>3-fold elevation in ALT/AST).
• •HBV or HCV carriers.
• •Severe pulmonary disease (e.g. severe chronic obstructive pulmonary disease).
• •Subjects with Acute Stroke within 6 months prior to screening.
• •Subjects with uncontrolled diabetes mellitus.
• •Specific ophthalmologic conditions that preclude retinal photography,vascular lesions of the anterior segment of the eye, proliferative retinopathy, age-related macular degeneration or intra-ocular surgery within 6 months prior to enrollment.
• •Gross obesity (BMI≥40).
• •Buerger's disease or other forms of inflammatory arteritis.
• •Class IV congestive heart failure, as defined by the New York Heart Association or a myocardial infarction within 6 months prior to screening.
• •Subject with deep vein thrombosis within 3 months prior to screening.
• •Inability to complete the standardized treadmill protocol for reasons other than claudication including symptoms such as angina, dyspnea, joint pains, or excessive fatigue.
• •Percutaneous intervention or surgical revascularization in the index lower limb within 6 months prior to enrollment.
• •Heart angioplasty with or without stent or coronary bypass surgery within the past 6 months.
• •Participation in a structured exercise treatment protocol within 30 days prior to screen testing.
• •Subject is planning to participate in a structured exercise treatment protocol during the 180 days following administration of the investigational product.
• •Participation in a previous gene transfer trial in which the subject received active investigational product (placebo subjects are eligible).
• •Concurrent or prior participation in another clinical trial within 30 days prior to screen testing.
• •Chronic use of Cox-2 inhibitors, defined as subjects needing daily use of the agent for more than 30 days prior to screening.
• •Subject is taking any of the following drugs for life-threatening conditions or as part of a life-sustaining treatment: Cyclosporine (Sandimmune®),Systemic androgens/anabolic steroids, systemic corticosteroids.
• •History of bleeding diathesis (e.g. hemophilia due to Factor VIII or IX deficiency).
• •Pregnancy or breast-feeding.
• •Uncontrolled hypertension or significant hypotension.
• •Immunodeficiency states (e.g, current HIV positivity, or organ transplant recipient) or subject receiving immunosuppressive medications.
• •Alcohol or other substance abuse.