Safety Study of MultiGeneAngio in Patients With Chronic Critical Limb Ischemia

Inclusion Criteria: * Men and women 50 years of age or older * Ischemic rest pain (Rutherford category 4) and/or * Non-healing wounds (Rutherford category 5) * ABI of 0.5 or less, or TBI of 0.3 or less * Ankle systolic pressure of 70 mm Hg or less, or toe systolic pressure of 50 mm Hg or less * Poor or no option for conventional revascularization Exclusion Criteria: * Life expectancy of less than one year * Presence of significant inflow disease (\>50% stenosis) in the distal aorta, common or external iliac * Advanced CLI, characterized by extensive tissue loss or gangrene (Rutherford category 6) * Previous major amputation on the leg to be treated or planned major amputation within a month from enrollment * Evidence of osteomyelitis * Ischemic wounds with uncontrolled infectious symptoms * Heart angioplasty or CABG within 3 months prior to enrollment * Severe congestive heart failure (New York Heart Association stage IV) * Acute cardiovascular event within 3 months prior to enrollment * Uncontrolled blood pressure: SBP≥ 180 mmHg or DBP ≥110 mmHg * Known Buerger's disease * History of bleeding diathesis (e.g., hemophilia due to Factor VIII or IX deficiency) * Renal failure defined as a serum creatinine \>2.5mg/dL * Significant hepatic disease:\>3-fold elevation in ALT/AST, HBV or HCV carriers * Severe pulmonary disease * Active proliferative retinopathy and/or severe macular oedema * Intra-ocular surgery within 6 months prior to enrollment * Immunodeficient states (e.g. known HIV positivity, or organ transplant recipient) or subject receiving immunosuppressive medication * History of malignant neoplasm (except curable non-melanoma skin malignancies) within 5 years prior to enrollment * Pregnant or lactating women * Previous treatment with angiogenic growth factors or stem cells * No demonstrable venous access * Known hypersensitivity to VEGF, Angiopoietin-1, or heparin