Allogeneic Heart Stem Cells to Achieve Myocardial Regeneration

Exclusion Criteria

• •1. Participants with a history of coronary artery bypass surgery, and a patent graft (arterial or saphenous vein graft) attached to the coronary artery to be infused.
• •2. Diagnosed or suspected myocarditis.
• •3. History of cardiac tumor, or cardiac tumor demonstrated on screening MRI.
• •4. History of acute coronary syndrome in the 4 weeks prior to study infusion.
• •5. History of previous stem cell therapy.
• •6. History of radiation treatment to the central or left side of thorax.
• •7. Current or history (within the previous 5 years) of systematic auto-immune or connective tissue disease including, but not limited to, giant cell myocarditis, cardiac or systemic sarcoidosis, Dressler's syndrome, chronic recurrent or persistent pericarditis.
• •8. History of or current treatment with immunosuppressive, anti-inflammatory, or other agents to treat manifestations of systemic immunologic reactions, including chronic systemic corticosteroids, biologic agents targeting the immune system, anti-tumor and anti-neoplastic drugs, anti-vascular endothelial growth factor, or chemotherapeutic agents within 3 months prior to enrollment.
• •9. Prior implantable cardioverter defibrillator (ICD) and/or pacemaker placement where study imaging site has not been trained and certified specifically for this protocol to conduct cardiac MRI in participants with ICD and/or pacemaker placement.
• •a. Presence of a pacemaker and/or ICD generator with any of the following limitations/conditions are excluded: i. Manufactured before the year 2000, ii. Leads implanted \< 6 weeks prior to signing informed consent, iii. Non-transvenous epicardial, abandoned, or no-fixation leads, iv. Subcutaneous ICDs, v. Leadless pacemakers, vi. Any other condition that, in the judgement of device-trained staff, would deem an MRI contraindicated.
• •b. Pacemaker dependence with an ICD (Note: pacemaker-dependent candidates without an ICD are not excluded).
• •c. A cardiac resynchronization therapy (CRT) device implanted \< 3 months prior to signing informed consent.
• •10. Estimated glomerular filtration rate \< 30 mL/min.
• •11. Participation in an on-going protocol studying an experimental drug or device, or participation in an interventional clinical trial within the last 30 days.
• •12. Diagnosis of arrhythmogenic right ventricular cardiomyopathy.
• •13. Current alcohol or drug abuse.
• •14. Pregnant/nursing women and women of child-bearing potential that do not agree to use at least two forms of active and highly reliable method(s) of contraception. Acceptable methods of contraception include contraceptive pills, depo-progesterone injections, a barrier contraceptive such as a condom with or without spermicide cream or gel, diaphragms or cervical cap with or without spermicide or gel, or an intrauterine device (IUD).
• •15. Human Immunodeficiency Virus (HIV) infection.
• •16. Viral hepatitis.
• •17. Uncontrolled diabetes (HbA1c\>9%).
• •18. Abnormal liver function (Serum Glutamic Pyruvic Transaminase/Alanine aminotransferase \> 3 times the upper reference range) and/or abnormal hematology (hematocrit \< 25%, White Blood Cell \< 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 IV 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.
• •26. Any malignancy within 5 years (except for in-situ non-melanoma skin cancer and in-situ cervical cancer) of signing the informed consent form.
• •27. Any condition or other reason that, in the opinion of the Investigator or Medical Monitor, would render the participants unsuitable for the study.