A Phase 3 interventional study of Intramyocardial injection of autologous bone marrow cells in Ischemic Heart Disease and Coronary Artery Disease, sponsored by Ministry of Health, Brazil. Terminated at 6 sites in Brazil. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-01-27.
Sponsored by Ministry of Health, Brazil · Phase 3, Interventional, and Treatment
This study was designed to test the hypothesis that direct injection of bone-marrow cells in the heart may increase the number of blood vessels, ameliorating the heart's performance, and relieving patients from symptoms like angina and/or shortness of breath.
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).
3,242 studies on the registry are indexed under Myocardial Ischemia; 390 are open to participants now.
This study's planned enrollment of 300 is above the median of 120 across 1,901 interventional studies indexed under Myocardial Ischemia.
Browse Myocardial Ischemia studies →Ministry of Health, Brazil is the lead sponsor of 11 studies on the registry; none are open to participants now.
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Abnormal myocardial perfusion tests:
i. Cardiac scintigraphy ii. Magnetic resonance imaging iii. Dobutamine-atropine stress-echocardiogram
Non-candidates for a percutaneous coronary intervention (PCI) due to ANY of the following:
i. High risk lesion ii. Extensive lesion iii. Diffuse, small vessel disease
Exclusion Criteria:
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.
The record gives a start of Jan 2006, a primary completion of Nov 2008 and a completion of Nov 2008. It does not say whether these dates are actual or estimated.
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This study is terminated, as verified in Nov 2008. You cannot join it, but the record below documents what was studied.
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Ministry of Health, Brazil