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

Stopped early · Phase 1

Conditions studied: Critical Limb Ischemia

In brief

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.

Key facts

Study ID: NCT01019681
Run by: Richard Burt, MD
People needed: 1
Starts: 2009-11-01
Expected to finish: 2014-01-01
Last updated by the study team: 2014-02-03

Who can join

Age: 18 and older, up to 72. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Atherosclerotic ischemic peripheral vascular disease or Thromboangiitis Obliterans with Critical Limb Ischemia (Fontaine stages III and IV)
Participant must match either a or b
Ankle brachial index (ABI) ≤ 0.7
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)

You may not qualify if…

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%

Where it is running

Northwestern University — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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