Please select the eligibility criteria that correspond to the clinical trial below.
Title: Autologous Immunomagnetic Selected cd133+ Cells in the Treatment of No-option Critical Limb Ischemia: Clinical and Ceus Assessed Results.
Brief Summary: Aim: to value the safety and efficacy of local intramuscular administration of immunoselected autologous endothelial progenitor cells in the treatment of critical limb ischemia in patients without revascularization options.

Primary goal: to value the feasibility of mobilization, harvesting, immunoselection and auto transplantation of endothelial progenitor cells.

Secondary goal: to value the efficacy of local administration of autologous endothelial progenitor cells in the treatment of critical limb ischemia


Options:
A: Inclusion Criteria:

* Age \> 18 years
* Severe Peripheral Artery Disease (PAD; Fontaine class III and / or IV):

  * Fontaine III (Rutherford 4): persistent, recurring rest pain requiring analgesia
  * Fontaine IV (Rutherford 5): non-healing ulcers present for \> 4 weeks without evidence of improvement in response to conventional therapies
* Ankle brachial index \< 0.6 or unreliable (non-compressible or not in proportion to the Fontaine classification)
* Not eligible for surgical or endovascular revascularization
* Written informed consent.

Exclusion Criteria:

* History of neoplasm or malignancy in the past 10 years
* Serious known concomitant disease with life expectancy of less than one year
* Rutherford 6 in which amputation on the short term (within 1-2 weeks) is inevitable
* Pregnancy or unwillingness to use adequate contraception during study
* Uncontrolled acute or chronic infection with systemic symptoms
* Follow-up impossible.
B: Inclusion Criteria:

* History of exercise-limiting intermittent claudication and peripheral arterial disease with symptoms in one or both legs, of at least 2 months duration with no change in symptom severity in the 2 months prior to screening.
* A Doppler-measured ankle-brachial index (ABI) of ≤0.80 or toe-brachial index (TBI) of \<0.70 in at least one leg after 10 minutes of rest.
* Limitation in walking secondary to claudication with a mean peak walking time (PWT) of between 1 and 10 minutes on a standardized Gardner protocol for exercise treadmill test (ETT).
* Angiographic or equivalent anatomic evidence (MRA) of arterial occlusive disease (\>70%) in the distal common femoral artery or superficial femoral artery and its branches of at least one leg within 12 months prior to screening.
* Postmenopausal (females),surgically sterile, or use adequate birth control.

Exclusion Criteria:

* Presence of significant inflow disease \[defined as \>50% stenosis\] in the distal aorta, common or external iliac as assessed by conventional angiogram, digital subtraction angiography (DSA), or magnetic resonance angiography (MRA) performed \< 1 year prior to screening.
* Critical limb ischemia, either chronic or acute ischemia manifested by rest pain, ulceration, or gangrene (Category 4 through 6 of Society for Vascular Surgery \[SVS\] classification \[Rutherford\]).
* History of malignant neoplasm (except curable non-melanoma skin malignancies).
* Renal failure (serum creatinine \>2.0 mg/dL) or end-stage renal disease(requiring hemodialysis or renal replacement therapy).
* Significant hepatic disease (\>3-fold elevation in ALT/AST).
* HBV or HCV carriers.
* Severe pulmonary disease (e.g. severe chronic obstructive pulmonary disease).
* Subjects with Acute Stroke within 6 months prior to screening.
* Subjects with uncontrolled diabetes mellitus.
* Specific ophthalmologic conditions that preclude retinal photography,vascular lesions of the anterior segment of the eye, proliferative retinopathy, age-related macular degeneration or intra-ocular surgery within 6 months prior to enrollment.
* Gross obesity (BMI≥40).
* Buerger's disease or other forms of inflammatory arteritis.
* Class IV congestive heart failure, as defined by the New York Heart Association or a myocardial infarction within 6 months prior to screening.
* Subject with deep vein thrombosis within 3 months prior to screening.
* Inability to complete the standardized treadmill protocol for reasons other than claudication including symptoms such as angina, dyspnea, joint pains, or excessive fatigue.
* Percutaneous intervention or surgical revascularization in the index lower limb within 6 months prior to enrollment.
* Heart angioplasty with or without stent or coronary bypass surgery within the past 6 months.
* Participation in a structured exercise treatment protocol within 30 days prior to screen testing.
* Subject is planning to participate in a structured exercise treatment protocol during the 180 days following administration of the investigational product.
* Participation in a previous gene transfer trial in which the subject received active investigational product (placebo subjects are eligible).
* Concurrent or prior participation in another clinical trial within 30 days prior to screen testing.
* Chronic use of Cox-2 inhibitors, defined as subjects needing daily use of the agent for more than 30 days prior to screening.
* Subject is taking any of the following drugs for life-threatening conditions or as part of a life-sustaining treatment: Cyclosporine (Sandimmune®),Systemic androgens/anabolic steroids, systemic corticosteroids.
* History of bleeding diathesis (e.g. hemophilia due to Factor VIII or IX deficiency).
* Pregnancy or breast-feeding.
* Uncontrolled hypertension or significant hypotension.
* Immunodeficiency states (e.g, current HIV positivity, or organ transplant recipient) or subject receiving immunosuppressive medications.
* Alcohol or other substance abuse.
C: Inclusion criteria:

1. age \> 18 years
2. written informed consent
3. critical limb ischemia (TASC 2 criteria)
4. No surgical nor endovascular options

Exclusion criteria:

1. clinical instability
2. extensive gangrene
3. every serious systemic disease
4. life expectancy \< 24 months
5. previous similar studies
6. previous experimental drug studies within 3 months
7. allergy
8. child bearing age
9. conflict of interest in the study
D: Inclusion Criteria:

* Ischemic lower limb based on TASK guide line
* Rutherford score:2,3
* ABI\<0.6
* Absolute ankle pressure \< 60 mmHg
* Both gender
* Age:20-62years

Exclusion Criteria:

* EF\<30%
* Cr\>2
* HbA1c\>8%
* Bone marrow disorders:leukemia
* Cognitive disorders
* Infections
* MI with ST elevation during last month
* Malignancy
* Immunologic or rheumatologic disorders

Answer: C