Status:
COMPLETED
Injection of Autologous CD34-Positive Cells for Critical Limb Ischemia
Lead Sponsor:
Losordo, Douglas, M.D.
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
Peripheral Artery Disease
Peripheral Vascular Disease
Eligibility:
All Genders
21-80 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of intramuscular injections of adult stem cells in patients with Critical Limb Ischemia (CLI).
Eligibility Criteria
Inclusion
- 21-80 years of age
- moderate or high-risk Critical Limb Ischemia (Rutherford Clinical Severity Score 4 or 5)
- unsuitable for conventional revascularization
Exclusion
- advanced CLI (Rutherford Clinical Severity Score 6) characterized by extensive tissue loss or gangrene
- advance AV block or NYHA Class III or Class IV heart failure
- myocardial infarction within 3 months of treatment
- successful coronary or lower extremity revascularization within 3 months of study enrollment
- arterial insufficiency in the lower extremity is the result of a non-atherosclerotic disorder with the exception of thromboangitis obliterans (Buerger's Disease)
- co-morbidity associated with life expectancy of less than 1 year
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00616980
Start Date
December 1 2007
End Date
August 1 2010
Last Update
July 25 2011
Active Locations (12)
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1
Cardiology, PC
Birmingham, Alabama, United States, 35211
2
Florida Research Network LLC
Gainsville, Florida, United States, 32605
3
Orlando Regional Medical Center
Orlando, Florida, United States, 32806
4
Northwestern University
Chicago, Illinois, United States, 60611