Allogeneic Heart Stem Cells to Achieve Myocardial Regeneration (ALLSTAR)

Inclusion Criteria:

1. History of anterior MI within the prior 4 weeks to 12 months due to coronary artery atherosclerotic disease and evidenced by typical ischemic symptoms, serial ST-T changes (new ST elevation or new left bundle block) and elevated troponin or CK-MB >5 times the upper limit of normal with at least one of the following: development of pathological Q wave ECG changes, imaging evidence of new loss of viable myocardium, or new regional wall motion abnormalities.
2. History of percutaneous coronary intervention (PCI), with or without stent placement resulting in TIMI flow = 3, in the left anterior descending coronary artery supplying the infarcted, dysfunctional territory and through which the treatment will be infused.
3. Left ventricular ejection fraction (LVEF) of ≤ 0.45 as determined by clinically-indicated assessment of cardiac function (echocardiography, gated blood pool scan, x-ray contrast ventriculography, CT and/or MRI) one day or more following successful reperfusion.
4. An area of regional dysfunction in the anterior LV wall, i.e. hypokinetic, akinetic, or dyskinetic, with no aneurysmal area as assessed by echocardiography, left ventriculography, or MRI one day or more following successful reperfusion.
5. Left ventricular ejection fraction of ≥ 0.25 and ≤ 0.50 and infarct size of ≥ 15% of left ventricular mass as determined by screening MRI. In patients with infarcts in ≥1 myocardial wall, >50% of the total LV scar should be in the anterior/anterolateral regions.
6. No further revascularization clinically indicated at the time the patient is assessed for participation in the clinical trial.
7. Ability to provide informed consent and follow-up with protocol procedures.
8. Age > 18 years.

Exclusion Criteria

1. Patients with a history of coronary artery bypass surgery, and a graft (left internal mammary artery or saphenous vein graft) attached to the left anterior descending coronary artery.
2. Measurable anti-Human Leukocyte Antigen (HLA) antibody levels (Panel Reactive Antibodies > 0%) at screening.
3. Diagnosed or suspected myocarditis.
4. History of cardiac tumor, or cardiac tumor demonstrated on screening MRI.
5. History of previous stem cell therapy.
6. History of radiation treatment to the chest or thorax.
7. History of treatment with immunosuppressive agents, including chronic systemic corticosteroids, biologic agents targeting the immune system, anti-tumor and anti-neoplastic drugs, anti-VEGF, or chemotherapeutic agents within 3 months prior to enrollment.
8. Contraindications to MRI, including prior ICD placement, estimated glomerular filtration rate < 50 mL/min (or GFR <30 mL/min during screening MRI), known reaction to gadolinium, claustrophobia, pacemaker, ear implant, and cochlear implant. Special screening may be required by individual study sites for patients with a history of possible presence of ferromagnetic material including programmable shunt, shrapnel, penile prosthesis, intrauterine device, bullets, tattoos, artificial limb, blood vessel coil, and tissue expander.
9. Non-cardiovascular disease with life expectancy of < 3 years.
10. Requirement for chronic immunosuppressive therapy.
11. Participation in an on-going protocol studying an experimental drug or device.
12. Diagnosis of arrhythmogenic right ventricular cardiomyopathy.
13. Current alcohol or drug abuse because of anticipated difficulty in complying with protocol-related procedures.
14. Pregnant/nursing women as well as men and women of child-bearing potential without use of active and highly reliable contraception.
15. Human Immunodeficiency Virus (HIV) infection.
16. Viral hepatitis.
17. Uncontrolled diabetes and/or hemoglobin A1C > 9%.
18. Abnormal liver function (SGPT > 3 times the upper reference range) and/or abnormal hematology (hematocrit < 25%, WBC < 3000 µl, platelets < 100,000 µl) studies without a reversible, identifiable cause.
19. Sustained ventricular tachycardia (VT) or non-sustained ventricular tachycardia > 30 beats, not associated with the acute phase of a previous MI (> 48 hours after the MI onset) or a new acute ischemic episode.
20. Ventricular fibrillation not associated with a new acute ischemic episode.
21. New York Heart Association (NYHA) Class 4 congestive heart failure.
22. Evidence of tumor on screening chest/abdominal/pelvic (body) CT scan.
23. Any prior transplant.
24. Known hypersensitivity to dimethyl sulfoxide (DMSO).
25. Known hypersensitivity to bovine products.