Study to Evaluate the Safety and Efficacy of JVS-100 Administered to Adults With Critical Limb Ischemia

Exclusion Criteria

• •Life expectancy of less than 1 year
• •Previous major amputation of the leg to be treated or planned major amputation within the first month following enrollment
• •Patent revascularization (within 6 weeks)in the leg to be treated prior to enrollment
• •NYHA Class IV heart failure
• •Evidence of osteomyelitis or active infection
• •Subjects with Buerger's Disease
• •Subjects with a history of Systemic Lupus Erythematosus (SLE) flare
• •Subjects with established chronic kidney (stage 5) requiring dialysis
• •Uncontrolled blood pressure
• •Significant hepatic disease
• •Diabetic subjects with active proliferative retinopathy
• •Immunodeficient states or subjects receiving chronic immunosuppressive therapy
• •Any patient with a history of cancer unless 1)the cancer was limited to curable non-melanoma skin malignancies, or 2)the cancer was removed by successful tumor resection, with or without radiation or chemotherapy, 5 years or more prior to enrollment in this study without recurrence
• •Pregnant or lactating women or subjects of childbearing potential not protected by an effective method of birth control
• •Men unwilling to agree to barrier contraception or limit sexual activity
• •Presence of any other condition that, in the opinion of the investigator, might compromise any aspect of the trial
• •Acute coronary syndrome within 3 month prior to enrollment
• •Previous treatment with angiogenic growth factors or with stem cell therapy within 1 year
• •Participation in another clinical trial in the last 30 days
• •Clinically significant elevations in PT/PTT/INR
• •Non-heel wound size \>20 cm2 (excluding toe gangrene) or heel wound size \>10cm2 on the index limb
• •History of drug or alcohol abuse in the last year