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 acute coronary syndrome (ACS) or a myocardial infarction in the month prior to consent
• A left ventricular wall thickness of <8 mm (by echocardiogram) of the infero-lateral wall at the target site for cell injection.
• Inability to walk on a treadmill, except for class IV angina patients, who will be evaluated separately
• Enrolled in an investigational device or drug study within the previous 30 days
• Hepatic dysfunction, as defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 1.5 times the upper limit of normal range prior to study entry
• Chronic renal insufficiency, defined as a serum creatinine level greater than 2.5 mg/dL or requiring dialysis
• Any other condition that in the judgment of the investigator would be a contraindication to enrollment or follow-up