Clinical Drug Experience Knowledgebase

Criteria

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