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Sponsored by: |
Duke University |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00691834 |
The purpose of this study is to test bone marrow mononuclear cells for patients with recent heart attack who are at high risk of experiencing heart failure. This study drug is made of you own cells. Studies similar to this one have suggested that the use of cell-based transfer after heart attack can improve the recuperation of the heart. The purpose of this study is to assess whether cell transfer can improve the healing of the heart after a heart attack.
Condition | Intervention | Phase |
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Acute Myocardial Infarction Heart Failure |
Biological: Intracoronary delivery of unfractionated bone marrow mononuclear cells Biological: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | ReNEW: A Phase 2, Randomized, Placebo-Controlled, Double-Blinded Study of the Efficacy and Safety of Autologous Bone Marrow Mononuclear Cell Transfer for Myocardial Salvage in Acute Myocardial Infarction |
Estimated Enrollment: | 50 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Intracoronary delivery of unfractionated bone marrow mononuclear cells
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Biological: Intracoronary delivery of unfractionated bone marrow mononuclear cells
Maximal intracoronary cell dose: 50 x 10e7 cells diluted in 10 ml Maximal intracoronary volume: 10 ml (diluted in plasma and culture medium)
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2: Placebo Comparator
Intracoronary delivery of placebo
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Biological: Placebo
Plasma and culture medium (10 ml)
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Christopher B Granger, MD | 919-668-8900 | christopher.granger@duke.edu |
Contact: Marc E Jolicoeur, MD MSc | 919-668-7808 | marc.jolicoeur@duke.edu |
United States, North Carolina | |
Duke Clinical Research Institute | |
Durham, North Carolina, United States, 27705 |
Principal Investigator: | Christopher B Granger, MD | Duke University |
Principal Investigator: | Marc E Jolicoeur, MD MSc | Duke University |
Responsible Party: | Duke Clinical Research Institute ( Dr Christopher B Granger ) |
Study ID Numbers: | Pro00003467 |
Study First Received: | June 3, 2008 |
Last Updated: | June 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00691834 |
Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
Magnetic resonance Imaging |
Necrosis Heart Failure Heart Diseases Myocardial Ischemia |
Vascular Diseases Ischemia Infarction Myocardial Infarction |
Pathologic Processes Cardiovascular Diseases |