Status:
COMPLETED
Stem Cell Mobilization by G-CSF to Treat Severe Peripheral Artery Disease
Lead Sponsor:
Washington University School of Medicine
Conditions:
Peripheral Vascular Diseases
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This study is designed to test the use of G-CSF in peripheral vascular disease. The investigators hypothesize that mobilization of angiogenic cells into the blood by granulocyte colony stimulating fac...
Detailed Description
One fourth of patients with peripheral artery disease (PAD) of the lower extremities have severe symptomatic disease and 1-2% have critical limb ischemia (CLI). In patients with CLI, the risk of limb ...
Eligibility Criteria
Inclusion
- Patients must have critical limb ischemia secondary to PAD, as defined by the presence of a non-healing ulcer, rest pain, or dry gangrene.
- Patients must have a toe pressure ≤ 30 mm Hg.
- Patients must be ≥18 years old.
- Patient must be able to self-administer a daily subcutaneous injection or have a caregiver who is able to administer a daily subcutaneous injection.
- Patients must be taking or have no absolute contraindication to taking aspirin and clopidogrel. If they are not currently taking aspirin, they must be willing to take aspirin (81 mg daily) and clopidogrel (75 mg daily) for 14 days starting on the first day of G-CSF treatment.
- After being informed of the treatment involved, patients must give written consent. The patient should not have any serious medical or psychiatric illness that would prevent either the giving of informed consent or the receipt of treatment. A built-in period of one week from discussion of the trial and initiation of the trial will be mandatory for enrollment.
Exclusion
- Patients with transmetatarsal or higher amputations in the affected limb are excluded.
- Patients who are candidates for a revascularization procedure.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00797056
Start Date
April 1 2008
End Date
April 1 2012
Last Update
April 1 2015
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110