Injection of Autologous CD34-Positive Cells for Critical Limb Ischemia
Completed · Phase 1/Phase 2
Conditions studied: Peripheral Artery Disease, Peripheral Vascular Disease, Critical Limb Ischemia
In brief
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).
Key facts
- Study ID
- NCT00616980
- Run by
- Losordo, Douglas, M.D.
- People needed
- 28
- Starts
- 2007-12-01
- Expected to finish
- 2010-08-01
- Last updated by the study team
- 2011-07-25
Who can join
Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 21-80 years of age
- moderate or high-risk Critical Limb Ischemia (Rutherford Clinical Severity Score 4 or 5)
- unsuitable for conventional revascularization
You may not qualify if…
- 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
Where it is running
- Cardiology, PC — Birmingham, Alabama, United States
- Florida Research Network LLC — Gainsville, Florida, United States
- Orlando Regional Medical Center — Orlando, Florida, United States
- Northwestern University — Chicago, Illinois, United States
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Mount Sinai School of Medicine Division of Vascular Surgery — New York, New York, United States
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
- University Hospitals of Cleveland, Case Medical Center — Cleveland, Ohio, United States
- University of Utah-Vascular Surgery Division — Salt Lake City, Utah, United States
- Swedish Medical Center — Seattle, Washington, United States
- Comprehensive Cardiovascular Care St. Luke's Medical Center — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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