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Sponsored by: |
Losordo, Douglas, M.D. |
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Information provided by: | Losordo, Douglas, M.D. |
ClinicalTrials.gov Identifier: | NCT00346177 |
The purpose of this study is to determine if cell therapy with your own cells (autologous cells) delivered with a catheter to regions of the heart with poor blood flow will be safe and if it will improve your ejection fraction and heart failure symptoms.
Condition | Intervention | Phase |
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Myocardial Ischemia Congestive Heart Failure Cardiovascular Disease |
Biological: Autologous Stem Cells |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Injection of Autologous CD34+ Cells for Neovascularization and Symptom Relief in Patients With Myocardial Ischemia and LVEF < 40% |
Estimated Enrollment: | 24 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Stem Cells
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Biological: Autologous Stem Cells
Intramyocardial injections
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2: Active Comparator
Stem Cells
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Biological: Autologous Stem Cells
Intramyocardial injections
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3: Placebo Comparator
Placebo
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Biological: Autologous Stem Cells
Intramyocardial injections
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Ages Eligible for Study: | 21 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States, 60611 |
Principal Investigator: | Douglas W. Losordo, M.D. | Northwestern University |
Responsible Party: | Northwestern University/Northwestern Memorial Hospital ( Director, Feinberg Cardiovascular Research Institute, Program in Cardiovascular Regenerative Medicine ) |
Study ID Numbers: | BB-IND-11196-02 |
Study First Received: | June 27, 2006 |
Last Updated: | August 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00346177 |
Health Authority: | United States: Food and Drug Administration |
heart stem Cells low EF heart attack cardiomyopathy |
congestive heart failure cardiovascular disease Heart Failure Low Ejection Fraction |
Heart Failure Heart Diseases Myocardial Ischemia Vascular Diseases |
Neovascularization, Pathologic Ischemia Cardiomyopathies Myocardial Infarction |
Pathologic Processes Cardiovascular Diseases |