Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure

Epicardial Injection of Allogeneic Human Pluripotent Stem Cell-derived Cardiomyocytes to Treat Severe Chronic Ischemic Heart Failure

The purpose of this clinical study is to evaluate the feasibility, safety and efficacy of intramyocardial injection of human induce pluripotent stem cell-derived cardiomyocytes (HiCM-188) during coronary artery bypass grafting (CABG) surgery in patients with severe chronic ischemic heart failure.

This is a single center, open-label, three-group dose-escalation (phase I) study followed by dose-extension (phase IIa) study in up to 36 severe ischemic heart failure patients. It is estimated that up to 18 phase I patients will be received HiCM-188 intramyocardial injection during CABG surgery. The maximum number of subjects after dose escalation and dose extension studies in each dose group is 12. All the subjects need take immunosuppressant after transplantation.

Inclusion Criteria:

1. Age ≥18 years
2. Willingness and ability to give written informed consent
3. Nuclide-myocardial metabolic perfusion imaging or Magnetic Resonance Imaging (MRI) revealed infarcted myocardium in the left anterior descending branch (LAD) coronary artery supply area
4. LVEF<50% as assessed by Echocardiography or LVEF≤40% as assessed by MRI
5. Patients have indications for Coronary Artery Bypass Grafting

Exclusion Criteria:

1. Presence of a pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy device (CRT)
2. Diagnosed with malignancy within 5 years
3. Autoimmune disease
4. Recipients of organ transplant.
5. Patients undergoing other surgical operations (excluding resection of ventricular aneurysm and left atrial appendage excision/occlusion).
6. Severe ventricular arrhythmia
7. Contraindication to CABG surgery
8. Contraindication to cardiac MRI or PET/CT scan.
9. Contraindication to immunosuppressants
10. Participation in another clinical trial within 3 months prior to screening
11. Pregnancy, lactation, or a positive serum pregnancy test
12. Any other condition considered by the investigator to be inappropriate for inclusion in this clinical trial