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

Exclusion Criteria

• •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)
• •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 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%