Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia

Inclusion Criteria: * Male or female, between 30 and 80years of age * Diagnosis of critical limb ischemia(ASO、TAO、DAO)，Rutherford Class 4 or 5, including: * A resting ankle systolic pressure of ≤ 70 mmHg in the affected limb; or * A resting toe systolic pressure of ≤ 50 mmHg in the affected limb; or * For patients in which measurement of ankle systolic pressure is not feasible , TcPO2 ≤ 30mmHg; Only unilateral affected limb receive treatment。 * Significant stenosis (≥ 75%) of one or more of the following arteries: superficial femoral, popliteal as verified by angiography（DSA、CTA、MRA） within 12 months prior to enrollment * Be willing to maintain current drug therapy for peripheral arterial disease throughout the course of the study * Be willing to maintain ulcer treatment * Be willing to infertility throughout the course of the study * If the subject is of child-bearing potential, she must have a negative urine pregnancy test result prior to study enrollment * Tumor screening result is no clinic meaning，including: * Signing the informed consent document prior to being subjected to any study related procedures Exclusion Criteria: * Subjects who have undergone a successful revascularization procedure or sympathectomy within 12 weeks prior to study entry. * Acute advanced CLI * Subjects that will require an amputation in the target leg within 4 weeks, or significant stenosis (≥ 75%) of Aortoiliac * Subjects with evidence of active infection or deep ulceration exposing bone or tendon in the extremity planned for treatment * Heart Failure with a NYHA classification of III or IV * Stroke、myocardial infarction or unstable angina within last 3 months * Uncontrolled hypertension defined as sustained systolic blood pressure (SBP) \> 180 mmHg or diastolic BP (DBP) \> 110 mmHg * Ophthalmologic conditions pertinent to proliferative retinopathy or conditions that preclude standard ophthalmologic examination * Can not correctly describe the symptoms and feeling * Subjects with advanced liver disease including decompensated cirrhosis, jaundice, ascites or bleeding varices * Subjects currently receiving immunosuppressive medications chemotherapy, or radiation therapy * Positive HIV,active Hepatitis B(determined by HBsAb\\ HBcAb\\HBsAg) or C infection * Specific laboratory values at Screening including: Hemoglobin \< 8.0 g/dL, WBC \< 3,000 cells per microliter, platelet count \<75,000/mm3, AST and/or ALT \> 3 times the upper limit of normal or any other clinically significant lab abnormality which in the opinion of the investigator should be exclusionary * Elevated PSA unless prostate cancer has been excluded * Patients with a recent history (\< 5 years) of or new screening finding of malignant neoplasm except basal cell carcinoma or squamous cell carcinoma of the skin (if excised and no evidence of recurrence); patients with family history of colon cancer in any first degree relative are excluded unless they have undergone a colonoscopy in the last 12 months with negative findings * Subjects requiring \> 100 mg daily of acetylsalicylic acid,COX-2 inhibitor drug(s) or high dose steroids (excepting inhaled steroids) * Subjects with any co- morbid conditions likely to interfere with assessment of safety or efficacy or with an estimated life expectancy of less than 12 months * History of drug or alcohol abuse / dependence in the past 12 months * Use of an investigational drug or treatment in past 3 months