- Trial ID:
- Richard Schatz
- 1. History of MI (STEMI or NSTEMI) within the prior 12 months due to a coronary artery event and evidenced by at least two of the following: typical ischemic symptoms, serial ST-T changes (new ST elevation or new left bundle block) and/or elevated troponin or CK-MB >5 times the upper limit of normal. Also 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 stent placement resulting in TIMI flow = 3, in the coronary artery supplying the infarcted, dysfunctional territory and through which the treatment will be infused.
- 3. At least one assessment of left ventricular ejection function (LVEF) ≤0.45 as determined by any one of the standard modalities (echocardiography, ventriculography, nuclear imaging, CT and/or MRI) prior to or during the screening period.
- For subjects that fulfill the criteria of Recent MI (i.e., within 90 days of MI) at time of screening visit: assessment must be post-reperfusion after index MI and the most recent test prior to or during the screening period.
- For subjects that fulfill the criteria of Chronic MI (i.e., greater than 90 days from MI) at the time of screening visit: assessment must be at least 21 days post-reperfusion after index MI and the most recent test prior to or during the screening period.
Note: subjects may screen as a Recent MI but be randomized into the Chronic MI strata if the infusion date is > 90 days post-MI.
- 1. Subjects 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-VEGF, or chemotherapeutic agents within 3 months prior to enrollment.
- 9. Prior ICD and/or pacemaker placement where study imaging site has not been trained and certified specifically for this protocol to conduct cardiac MRI in subjects with ICD and/or pacemaker placement.
- 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 (SGPT/ALT > 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 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 ICF.
- 27. Any condition or other reason that, in the opinion of the Investigator or Medical Monitor, would render the subject unsuitable for the study.
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.