Injection of Autologous CD34-Positive Cells for Critical Limb Ischemia
NCT ID: NCT00616980
Last Updated: 2011-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
28 participants
INTERVENTIONAL
2007-12-31
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Low Dose
CD34-positive cells
High Dose
CD34-positive cells
Saline
Saline and 5% autologous plasma
Interventions
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CD34-positive cells
CD34-positive cells
Saline and 5% autologous plasma
Eligibility Criteria
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Inclusion Criteria
* moderate or high-risk Critical Limb Ischemia (Rutherford Clinical Severity Score 4 or 5)
* unsuitable for conventional revascularization
Exclusion Criteria
* 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
21 Years
80 Years
ALL
No
Sponsors
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Baxter Healthcare Corporation
INDUSTRY
Losordo, Douglas, M.D.
INDIV
Responsible Party
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Northwestern University
Locations
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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
Countries
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References
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Moazzami B, Mohammadpour Z, Zabala ZE, Farokhi E, Roohi A, Dolmatova E, Moazzami K. Local intramuscular transplantation of autologous bone marrow mononuclear cells for critical lower limb ischaemia. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD008347. doi: 10.1002/14651858.CD008347.pub4.
Losordo DW, Kibbe MR, Mendelsohn F, Marston W, Driver VR, Sharafuddin M, Teodorescu V, Wiechmann BN, Thompson C, Kraiss L, Carman T, Dohad S, Huang P, Junge CE, Story K, Weistroffer T, Thorne TM, Millay M, Runyon JP, Schainfeld R; Autologous CD34+ Cell Therapy for Critical Limb Ischemia Investigators. A randomized, controlled pilot study of autologous CD34+ cell therapy for critical limb ischemia. Circ Cardiovasc Interv. 2012 Dec;5(6):821-30. doi: 10.1161/CIRCINTERVENTIONS.112.968321. Epub 2012 Nov 27.
Other Identifiers
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11931-02
Identifier Type: OTHER
Identifier Source: secondary_id
STU00009937/STU00001469
Identifier Type: -
Identifier Source: org_study_id
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