Efficacy and Safety of Umbilical Cord Blood Injection for Critical Limb Ischemia

Inclusion Criteria:

• Atherosclerotic ischemic peripheral vascular disease or Thromboangiitis Obliterans with Critical Limb Ischemia (Fontaine stages III and IV)

• Participant must match either a or b

  1. Ankle brachial index (ABI) ≤ 0.7
  2. Doppler waveforms at posterior tibial artery and dorsalis pedis artery are monophasic with toe pressure < 30 mmHg.
• A non-surgical candidate for revascularization e.g. prior vascular reconstruction, inability to locate a suitable vein for grafting, diffuse multi- segment disease, or extensive infra-popliteal disease not amenable to a vascular graft.
• Age > 18 years old.
• The non-index leg may be treated only in the event and it full fills the same eligibility criteria and exclusion criteria used in this protocol for the treatment leg.
• Patients must be on maximal tolerated medical therapy for PVD including A) Cessation of smoking B) Referral to endocrinologist for control of HgA1c to < 7.0 mg/dl, control of hyperlipidemia with statins or other anti-hyperlipidemic drugs as indicated, control of hypertension as indicated C) Antiplatelet therapy with aspirin and / or cilostazol (unless medically contraindicated, e.g. bleeding or allergy)

Exclusion Criteria:

• Popliteal vascular entrapment syndrome
• Lower extremity infection or infected ulcer
• Hypercoagulable state
• HIV positive
• HBsAg positive
• Uncontrolled arrhythmia, that is, persistence of an arrhythmia despite medical therapy
• Unstable angina
• Thrombocytopenia < 50,000/ul
• Leukemia or myelodysplasia
• Allergy to E coli or its products
• Patients with metal in their bodies cannot undergo MRIs (MRA). Therefore, patients with, cochlear implants, or aneurysm clips are not eligible. Coronary artery stents are not a contraindication. Patients with pacemakers are still candidates provided they have normal creatinine (< 1.1 mg/dl) and can receive contrast dye (no allergy) for angiogram instead of MRA. MRI/MRA does not need to be repeated if a prior MRA or Angiogram Demonstrates inoperable disease.
• Patients who are pregnant
• Poorly controlled diabetes will not be a cause for exclusion but patient must see endocrinologist for better control
• Current malignancy, except squamous cell or basal cell skin cancers thought to be easily controlled.
• AST, ALT, or bilirubin more than twice the upper limit of normal.
• WBC < 2.5 / ul.
• Any patient who is actively bleeding, including blood on urine dipstick or fecal occult blood.
• Patient is on chemotherapy or other immuno-suppressive medications such as steroids, cellcept, cyclosporine, cytoxan, azathioprine, rituxan, humira or remicade.
• Donor is HLA homozygous and shares that HLA haplotype with the recipient (a different donor will have to be found)
• Patients diagnosed with Thromboangiitis Obliterans (Buerger's Disease) who are smokers and are unwilling or unable to quit smoking
• A) Patients with a myocardial infarction within the last 30 days or left ventricular ejection fraction < 35% B) Patients with a history of malignancy in the last 5 years (other than basal cell carcinoma or carcinoma in situ) C) Patients with a CVA within the last 6 months D) Patients with a HbA1c level > 7.0%