Randomized, Double-Blind, Placebo-Controlled Phase I/II Study of the Safety and Efficacy of Intracoronary Delivery of Allogeneic Cardiosphere-Derived Cells in Patients With an Anterior Myocardial Infarction and Ischemic Left Ventricular Dysfunction (ALLogeneic Heart STem Cells to Achieve Myocardial Regeneration, ALLSTAR)

Trial ID:
IRB-13-6175
Richard Schatz
The purpose of this study is to determine whether Allogeneic Cardiosphere-Derived Cells (CAP-1002) is safe and effective in decreasing infarct size in patients with a myocardial infarction.

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, based on standardly accepted definition of acute MI: 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 left anterior descending coronary artery supplying the infarcted, dysfunctional territory and through which the treatment will be infused.
  • 3. At least one historical assessment of left ventricular ejection function (LVEF) ≤0.45 as determined by any one of the standard modalities (echocardiography, ventriculogram, nuclear imaging, CT and/or MRI). Recent MI: assessment must be post-reperfusion after index MI and be the most recent test prior to signing informed consent. Chronic MI: assessment must be at least 21 days post-reperfusion after index MI and the most recent test prior to signing informed consent.
  • 4. Left ventricular infarct size of ≥ 15% of left ventricular mass as determined by screening MRI, with associated thinning and/or hypokinesis, akinesis, or dyskinesis, with no large aneurysmal area in the anterior/anterolateral/anteroseptal regions . In subjects with infarcts in >1 myocardial wall, >50% of the total LV scar should be in the anterior/anterolateral/anteroseptal regions.
  • 5. No further revascularization clinically indicated at the time the subject is assessed for participation in the clinical trial.
  • 6. Ability to provide informed consent and follow-up with protocol procedures.
  • 7. Age ≥18 years.

Exclusion Criteria:

  • 1. Subjects 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. Diagnosed or suspected myocarditis.
  • 3. History of cardiac tumor, or cardiac tumor demonstrated on screening MRI.
  • 4. History of previous stem cell therapy.
  • 5. History of radiation treatment to the chest or thorax.
  • 6. 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.
  • 7. 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.
  • 8. Contraindications to MRI, including prior ICD and/or pacemaker placement, estimated glomerular filtration rate < 30 mL/min.
  • 9. Non-cardiovascular disease with life expectancy of < 3 years.
  • 10. Participation in an on-going protocol studying an experimental drug or device or participation in an interventional clinical trial within the last 30 days.
  • 11. Diagnosis of arrhythmogenic right ventricular cardiomyopathy.
  • 12. Current alcohol or drug abuse or an inability to comply with protocol-related procedures.
  • 13. Pregnant/nursing women and women of child-bearing potential without use of active and highly reliable contraception.
  • 14. Human Immunodeficiency Virus (HIV) infection.
  • 15. Viral hepatitis.
  • 16. Uncontrolled diabetes (HbA1c>9%)
  • 17. 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.
  • 18. 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.
  • 19. Ventricular fibrillation not associated with a new acute ischemic episode.
  • 20. New York Heart Association (NYHA) Class IV congestive heart failure.
  • 21. Evidence of tumor on screening chest/abdominal/pelvic (body) CT scan.
  • 22. Any prior transplant.
  • 23. Known hypersensitivity to dimethyl sulfoxide (DMSO)
  • 24. Known hypersensitivity to bovine products.
  • 25. Any malignancy within 5 years (except for in-situ non-melanoma skin cancer and in-situ cervical cancer).