Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase I / II Clinical Trial Regarding Vascular Regeneration Therapy by Transplantation of Autologous Peripheral Blood Endothelial Progenitor Cells (CD34+ Cells) in No-Option Patients With Chronic Critical Limb Ischemia
Brief Summary: The purpose of this study is to determine if stem cell therapy with one's own cells (autologous cells) delivered intramuscularly to one's leg with ulcer and/or gangrene due to poor blood flow will be safe and if it will relieve leg pain, increase blood flow, and/or cure the leg wound.


Options:
A: 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
B: Inclusion Criteria:

* Chronic severe CLI patients fulfilling all the following criteria are considered suitable for inclusion in the study.

  1. At least 6 months since the onset of CLI (Chronic peripheral artery disease or Buerger disease)
  2. Patients with luminal stenosis \> 50% by leg angiography
  3. Age is between 20 and 80.
  4. Patients whose Rutherford's class is II-4, III-5, or III-6（Patients with rest pain or ischemic ulcer/necrosis)
  5. Patients for whom angioplasty and bypass surgery are not indicated because of anatomical or procedural reasons or frequent reocclusion/ restenosis following the traditional revascularization (No option patients)
  6. Patients who can give informed consent themselves in writing.

Exclusion Criteria:

* Any one of the following exclusion criteria is sufficient to disqualify a patient from the study.

  1. Left ventricular ejection fraction \< 25%
  2. Patients with a history of severe allergic reactions or side effects to G-CSF preparations or apheresis.
  3. Less than 6 months since last episode of myocardial/cerebral infarction.
  4. Patients with unstable angina, with a treatment rating of 3 in the Braunwald system, but a severity of III and a clinical rating of B or C.
  5. Patients with diabetic proliferating retinopathy (new Fukuda classification BI to BV).
  6. Patients with malignant tumor
  7. Patients with chronic rheumatoid arthritis.
  8. Patients with hematological disease (leukemia, myeloproliferative disease, or myelodysplastic syndromes).
  9. Patients currently suffering from or having a history of interstitial pneumonitis.
  10. Patients for whom cranial MRA reveals cerebral aneurysm.
  11. Patients for whom abdominal CT or ultrasonography reveals splenomegaly.
  12. Patients with cirrhosis of the liver.
  13. Patients who cannot discontinue Warfarin.
  14. Leukocytes less than 4,000/µL or exceeding 10,000/µL.
  15. Platelets less than 100,000/µL.
  16. Hemoglobin less than 10 g/dL.
  17. AST (GOT) exceeding 100 IU/L or ALT (GPT) exceeding 100 IU/L.
  18. Patients with severe neural disorder in their legs.
  19. Patients with gait disturbance for reasons other than CLI (such as sciatic neuralgia, or vasculitis), making exercise tolerance evaluation on a treadmill with stress ECG difficult.
  20. Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study period.
  21. Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study.
C: Inclusion Criteria:

* Patients with unilateral critical chronic limb ischemia but not suitable candidates for non-surgical or surgical revascularization
* Before being included, the patient must be screened for human immunodeficiency virus, hepatitis B virus, hepatitis C virus, treponema pallidum

Exclusion Criteria:

* Buerger disease
* Ischemic ulcers with infectious symptoms
* Diabetes mellitus with HbA1c \> 7,5% or with proliferative retinopathy
* Past or current malignancy
* Contra-indication to general anaesthesia
* Chronic haemodialysis
* Prothrombin Time \< 60%,
* Recent onset (within 3 months) of myocardial infarction or brain infarction
* Coronary angioplasty within 1 year
* Atrial fibrillation, mechanical mitral prosthetic valve
* Unexplained hematological abnormality.
* Expected life span less than six months
* Patient not competent to give informed consent
D: Inclusion Criteria:

1. Be ≥ 40 and ≤90 years of age.
2. Patients requiring lower extremity major amputation, as determined by an independent vascular specialist.
3. If ulceration or gangrene present, it is distal to malleoli (to allow adequate length of ATM area of approximately 3cm x 10cm x 3 cm)
4. Amputation can safely be performed up to 30 days after screening, as determined by an independent vascular or orthopedic surgeon.
5. Females of childbearing potential must be willing to use one form of birth control for the duration of the study. Female participants must undergo a blood or urine pregnancy test at screening.

Exclusion Criteria:

1. Patients who are pregnant, planning to become pregnant in the next 12 months, or lactating.
2. CHF hospitalization within the last 1 month prior to enrollment.\*
3. Acute coronary syndrome in the last 1 month prior to enrollment.\*
4. HIV positive, or active, untreated HCV as determined by review of medical records.
5. History of cancer within the last 5 years, except basal cell skin carcinoma
6. Inability to provide written informed consent due to cognitive or language barriers (interpreter permitted).
7. Concurrent enrollment in another clinical investigative trial that may alter the outcomes of enrollment in this trial.
8. Any condition requiring immunosuppressant medications (e.g., for treatment of organ transplants, psoriasis, Crohn's disease, alopecia areata).
9. Presence of any clinical condition that in the opinion of the PI or the sponsor makes the patient not suitable to participate in the trial.

   * As defined by the standard definitions of CHF and ACS by the American Heart Association.

Answer: B