Cell Therapy in Severe Chronic Ischemic Heart Disease

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

Patients with advanced coronary artery disease usually undergo incomplete myocardial revascularization due to the extension and diffuseness of the disease, with very poor distal arterial beds unsuitable for direct revascularization.

This study was designed to test the hypothesis that direct, intramyocardial injection of autologous bone marrow cells may further improve myocardial perfusion in patients undergoing incomplete bypass surgery.

All eligible patients will undergo coronary artery bypass grafting (CABG) and, in previously identified areas of viable, ischemic myocardium unsuitable for direct revascularization, be randomized to either placebo (saline) or intramyocardial injection of bone marrow-derived cells (BMC) during surgery.

During follow-up, myocardial perfusion assessment will be performed to determine the improvement in treated areas compared to non-treated segments.

Inclusion Criteria:

• symptoms of angina or angina equivalent
• documented coronary artery disease (invasive angiography)
• documented myocardial ischemia (stress echo, cardiac scintigraphy, or MRI)
• unsuitable for complete myocardial revascularization (PCI or CABG) OR even if a complete procedure in feasible, it is anticipated that myocardial perfusion may not be restored due to poor distal beds

Exclusion Criteria:

• severe LV dysfunction (EF < 25% on echo)
• short life expectacy (below < 1 year)
• diagnosis of cancer in the past 5 years
• diagnosis of hematological diseases
• diagnosis of severe heart disease of other etiologies including valvular heart disease, Chagas' disease, etc)
• diagnosis of acute coronary syndrome in the past 3 months
• diagnosis of chronic kidney disease stage V requiring chronic dialysis