Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-1)

Exclusion Criteria

• •1\. Patients with acute lower limb ischemia or acute exacerbation of chronic lower limb ischemia.
• •2\. Vascular reconstruction (bypass or intravascular therapy) or sympathetic resection or amputation was performed within 4 weeks prior to the signing of the informed consent.
• •3\. Due to surgical operation, the patient is still in the postoperative risk period, and the researcher judges that the patient is not suitable for the test.
• •4\. Main-iliac artery stenosis 70%.
• •5\. Patients with ischemic ulcer of lower extremity.
• •6\. NYHA classification of cardiac function is classified as grade (see annex 1 for specific classification criteria).
• •7\. Patients with unstable angina pectoris due to cerebral infarction, cerebral hemorrhage and myocardial infarction within 3 months before signing the informed consent.
• •8\. Refractory hypertension (taking three or more antihypertensive drugs, systolic blood pressure 180mmHg or diastolic blood pressure 110mmHg).
• •9\. Proliferative retinopathy and retinopathy examination is not available.
• •10\. Inability to accurately describe symptoms and emotions.
• •11\. Severe liver disease with uncompensated cirrhosis, jaundice, ascites or hemorrhagic varices.
• •12\. Current recipients of immunosuppressants or chemoradiotherapy.
• •13\. Anti-hiv antibody positive, anti-hepatitis c antibody positive and hepatitis b surface antigen positive (if the subject is HBsAg positive and HBV DNA in peripheral blood is combined, the researcher believes that the subject's chronic hepatitis b is stable and will not increase the risk of the subject, the subject can be selected).
• •14\. Results of laboratory examination during screening period: hemoglobin \<80g/L, white blood cell count \< 3.0109 /L, platelet \<75 109/L, upper limit of normal AST or ALT\> 3 times, upper limit of normal serum creatinine \> 2.5 times, or other laboratory examination indicators appear abnormal that researchers think may affect the evaluation of test results.
• •15\. Patients with poor blood glucose control after treatment (hemoglobin a1c \>10%).
• •16\. Previously diagnosed with malignant tumor, or any of the following test results determined by the investigator to be at risk of tumor: fecal occult blood test;Chest X-ray examination or chest CT examination;Alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA) and ca19-9;Male subjects, prostate specific antigen test (PSA, free PSA);Female subjects, cervical smear (Pap), mammography/b-ultrasound and ca-125 examination;The investigators determined that additional tests were necessary to eliminate the tumor risk.
• •17\. In the opinion of the investigators, patients with comorbidities that affect safety and efficacy evaluation, or with a predicted survival of less than 12 months.
• •18\. Frequent drinkers within the 12 months prior to the signing of the informed consent, i.e., those who drank more than 14 units of alcohol per week (1 unit =360 mL beer or 45 mL alcohol of 40% spirits or 150 mL wine) or substance abusers.
• •19\. Participate in other clinical trials within 3 months before signing the informed consent.