Autologous Angiogenic Cell Precursors (ACPs) for the Treatment of Peripheral Artery Disease

Inclusion Criteria: * Subjects having 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 ; or non-healing ischemic ulcers; and * Subjects having one or more of the following hemodynamic indicators of severe peripheral arterial occlusive disease: I. Ankle brachial index ≤ 0.45 or II. Toe brachial index ≤ 0.35 or III. TcPO2 / TcO2 of ≤ 40 mmHg. * The subject being a poor candidate for standard revascularization treatment options for peripheral arterial disease, based on inadequate bypass conduit, or unfavorable anatomy; * Age 18 to 80 years; * Male or non-pregnant, non-lactating female; * Informed consent obtained and consent form signed. Exclusion Criteria: * Patient having on angiography a meaningful supra-popliteal occlusion that may relate to symptoms of CLI; * 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; * Patient who received blood transfusions during the previous 4 weeks (to exclude the potential of non-autologous ACPs in the harvested blood); * Inability to communicate (that may interfere with the clinical evaluation of the patient); * Major operation during the preceding 3 months; * Myocardial infarction or brain infarction or uncontrolled myocardial ischemia or persistent severe heart failure (EF\< 25 %) during the preceding 3 months; * Significant valvular disease or after valve replacement; * After heart transplantation; * Cardiomyopathy; * Renal failure (creatinine \> 2 mg/dl ); * Hepatic failure; * Anemia (lower than 11 mg/dl hemoglobin for female and lower than 12 mg/dl for male); * Abnormal coagulation tests \[platelets, PT (INR), PTT\]; * Stroke within the preceding 3 years; * Malignancy within the preceding 3 years; * Concurrent chronic or acute infectious disease; * Severe concurrent medical disease (e.g., septicemia, HIV-1,2/HBV/HCV infections, poorly controlled insulin-dependent diabetes mellitus; HbAlc \> 8% and proliferative retinopathy, systemic lupus erythematosus, multiple sclerosis, amyotrophic lateral sclerosis); * Chronic immunomodulating or cytotoxic drugs treatment; * Patients who have rectal temp. above 38.4 ºC for 2 consecutive days; * Patient unlikely to be available for follow-up.