The purpose of this study is to determine whether treatment with umbilical cord blood stem
cells will improve blood flow to the most severely affected leg of a participant with
medically refractory and non-surgical peripheral vascular disease of the lower extremity.
Minimum age: 18 Years.
Maximum age: 72 Years.
- 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
- 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
- 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
- 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
- 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%