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Sponsors and Collaborators: |
Losordo, Douglas, M.D. Baxter Healthcare Corporation |
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Information provided by: | Losordo, Douglas, M.D. |
ClinicalTrials.gov Identifier: | NCT00616980 |
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).
Condition | Intervention | Phase |
---|---|---|
Peripheral Artery Disease Peripheral Vascular Disease Critical Limb Ischemia |
Biological: Autologous Stem Cells (CD34+) |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Injection of Autologous CD34-Positive Cells for Improved Symptomatic Relief and Ischemic Wound Healing in Subjects With Moderate or High-Risk Critical Limb Ischemia |
Estimated Enrollment: | 75 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator |
Biological: Autologous Stem Cells (CD34+)
Intramuscular Injection
|
2: Active Comparator |
Biological: Autologous Stem Cells (CD34+)
Intramuscular Injection
|
3: Placebo Comparator |
Biological: Autologous Stem Cells (CD34+)
Intramuscular Injection
|
Ages Eligible for Study: | 21 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
Cardiology, PC | |
Birmingham, Alabama, United States, 35211 | |
United States, Florida | |
Florida Research Network LLC | |
Gainsville, Florida, United States, 32605 | |
Orlando Regional Medical Center | |
Orlando, Florida, United States, 32806 | |
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States, 60611 | |
United States, Iowa | |
University of Iowa Hospitals and Clinics | |
Iowa City, Iowa, United States, 52242 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
United States, New York | |
Mount Sinai School of Medicine Division of Vascular Surgery | |
New York, New York, United States, 10029 | |
United States, North Carolina | |
University of North Carolina at Chapel Hill | |
Chapel Hill, North Carolina, United States, 27514 | |
United States, Ohio | |
University Hospitals of Cleveland, Case Medical Center | |
Cleveland, Ohio, United States, 44106 | |
United States, Utah | |
University of Utah-Vascular Surgery Division | |
Salt Lake City, Utah, United States, 84132 | |
United States, Washington | |
Swedish Medical Center | |
Seattle, Washington, United States, 98122 | |
United States, Wisconsin | |
Comprehensive Cardiovascular Care St. Luke's Medical Center | |
Milwaukee, Wisconsin, United States, 53215 |
Responsible Party: | Northwestern University ( Director, Feinberg Cardiovascular Research Institute ) |
Study ID Numbers: | 11931-02 |
Study First Received: | January 24, 2008 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00616980 History of Changes |
Health Authority: | United States: Food and Drug Administration |
PAD PVD CLI Stem Cells |
Peripheral Vascular Diseases Vascular Diseases Ischemia |
Pathologic Processes Peripheral Vascular Diseases Vascular Diseases Cardiovascular Diseases Ischemia |