Cell Therapy in Chronic Ischemic Heart Disease
|Ischemic Heart Disease Coronary Artery Disease||Procedure: Intramyocardial injection of autologous bone marrow cells||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Intramyocardial Injection of Autologous Bone-Marrow Cells in Patients With Severe, Chronic Ischemic Heart Disease Undergoing Coronary Bypass Surgery|
- Reduction in the ischemic score (global/regional) at 12 months; increase in left ventricle ejection fraction (LVEF) at 12 months.
- All-cause and cardiovascular mortality during the first year; increase in VO2max, increase in quality of life, reduction in angina/heart failure functional class at 12 months; percentage of patients with a 5% increase in LVEF at 6 and 12 months.
|Study Start Date:||January 2006|
|Study Completion Date:||November 2008|
|Estimated Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
Severe ischemic heart disease (IHD) remains a clinical challenge; many patients with IHD have undergone myocardial revascularization procedures (either percutaneous or surgical) but still remain symptomatic despite maximally tolerated medical therapy. Others are considered non-optimal candidates for a complete myocardial revascularization procedure due to the extension and diffuseness of the disease.
Cell therapy with autologous bone marrow-derived cells (BMC) is a novel therapeutic strategy being tested for many cardiovascular diseases, including heart failure, acute myocardial infarction, chronic ischemic heart disease.
The primary objective of this study is to assess the efficacy of intramyocardial injection of autologous BMC on the myocardial perfusion and left ventricular function as an adjunctive therapy (compared to placebo) in patients undergoing coronary artery bypass surgery (CABG).
The secondary objective of this study is to assess the effect of intramyocardial injection of autologous BMC on functional class (angina/heart failure), functional capacity, global and cardiovascular mortality, and quality of life in patients undergoing coronary artery bypass surgery (CABG).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00362388
|Instituto do Coração de Pernambuco do Real Hospital Português de Beneficência|
|Recife, PE, Brazil, 52010-040|
|Irmandade da Santa Casa de Misericórdia|
|Curitiba, PR, Brazil, 80010-030|
|Clínica Cardiologyca C. Constantini|
|Curitiba, PR, Brazil, 80320-320|
|Instituto Nacional de Cardiologia Laranjeiras (INCL)|
|Rio de Janeiro, RJ, Brazil, 22240-002|
|Rio de Janeiro, RJ, Brazil, 22280-000|
|Heart Institute (InCor), Hospital das Clínicas, University of São Paulo Medical School|
|São Paulo, SP, Brazil, 05403-900|
|Principal Investigator:||Sergio A. de Oliveira, MD, PhD||Heart Institute (InCor), Hospital das Clinicas, University of São Paulo Medical School|
|Study Director:||Jose Eduardo Krieger, MD, PhD||Heart Institute (InCor), Hospital das Clinicas, University of São Paulo Medical School|