Effectiveness of Stem Cell Treatment for Adults With Ischemic Cardiomyopathy (The FOCUS Study)

Inclusion Criteria: * Patients \>18 years of age with significant coronary heart disease not amenable to revascularization. * Left ventricular dysfunction (LVEF) less than or equal to 45%, measured by echocardiogram; limiting angina (Class II to IV); and/or congestive heart failure (CHF), NYHA class II to III * Receiving maximal medical therapy, defined as a medical regimen that includes the maximal tolerated dose of at least two antiangina medications, such as beta-blockers, nitrates, or calcium-channel blockers * Presence of a defect, as identified by single photon emission computed tomography (SPECT) isotope protocol, or viability, as identified by NOGA electromechanical cardiac mapping system * Coronary artery disease not well suited to any other type of revascularization procedure in the target region of the ventricle, as determined by a cardiovascular surgeon and interventional cardiologist who are not investigators in the trial * Hemodynamic stability, as defined by systolic blood pressure of at least 80 mm Hg without intravenous pressors or support devices * Females of childbearing potential must be willing to use two forms of birth control for the duration of the study Exclusion Criteria: * Atrial fibrillation or flutter without a pacemaker that guarantees a stable heart rate * Unstable angina * Left ventricular (LV) thrombus, as documented by echocardiography or LV angiography * A vascular anatomy that precludes cardiac catheterization * Severe valvular disease or mechanical aortic valve that precludes safe entry of the catheter into the left ventricle * Pregnant or lactating * Platelet count less than 100,000 per mm3 * White blood cell count less than 2,000 per mm3 * Revascularization within 30 days of consent * Transient ischemic attack or stroke within 60 days of study consent * Implantable cardioverter-defibrillator shock within 30 days of baseline consent, and within 30 days of randomization * Presence of ventricular tachycardia lasting 30 seconds or more on 24-hour Holter monitor or electrocardiogram (ECG) performed during screening period * Bleeding diathesis, defined as an international normalized ratio of at least 2.0 in the absence of warfarin therapy * A history of malignancy in the last 5 years excluding basal cell carcinoma, that has been surgically removed, with proof of surgical clean margins * Has a known history of HIV, has active hepatitis B or active hepatitis C * Any condition requiring immunosuppressive medication * High-risk…