A Pivotal Clinical Trial of Human Induced Pluripotent Stem Cell-derived Cardiomyocytes Injection (HiCM-188) for the Treatment of Advanced Heart Failure(NYHA III-IV)

A Pivotal Multicenter, Randomized, Controlled Trial to Evaluate the Efficacy and Safety of Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) for the Treatment of Advanced Heart Failure(NYHA III-IV)

The purpose of this clinical study is to evaluate the efficacy and safety of intramyocardial injection of human induced pluripotent stem cell-derived cardiomyocyte injection (HiCM-188) in patients with advanced heart failure (NYHA Class III-IV)

REVIVE-HEART is a multicenter, randomized, controlled, confirmatory clinical trial evaluating patients with advanced heart failure (NYHA III-IV). Participants were assigned to receive either conventional coronary artery bypass grafting (CABG) alone or CABG combined with HiCM-188 (150 million cells). The cells were administered via myocardial injections around the infarcted area, followed by postoperative immunosuppressive therapy. Efficacy and safety were assessed 12 months post-treatment.

Inclusion Criteria:

1. Aged 18 to 75 years, regardless of gender;
2. Patients with ischemic heart failure with NYHA functional class III or IV after receiving the maximum tolerated dose of guideline-directed medical therapy (GDMT);
3. LVEF ≤ 35% as measured by cardiac MRI;
4. Coronary angiography meeting the indications for coronary artery bypass grafting (CABG) surgery;
5. Voluntary participation and signing of the informed consent form.

Exclusion Criteria:

Patients considered for this trial must not meet any of the following criteria:

1. Acute viral myocarditis;
2. Acute phase of myocardial infarction (≤ 3 months);
3. Cardiac amyloidosis;
4. Pericarditis;
5. Expected to undergo heart transplantation;
6. Suffering from a disease that restricts the motor system, making them unable to complete the 6-minute walk test;
7. Suffering from autoimmune diseases;
8. Estimated glomerular filtration rate (eGFR) < 35 ml/min/1.73m², or aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 100 U/L;
9. Presence of any untreated precancerous lesions or those requiring active monitoring;
10. Occurrence of malignant tumors within 5 years prior to screening;
11. Expected to undergo other concurrent cardiac surgeries (excluding ventricular aneurysm resection and left atrial appendage excision/ligation);
12. Having contraindications to the use of immunosuppressants;
13. Having contraindications to MRI;
14. Having contraindications to CABG surgery;
15. Females who are pregnant, lactating, or have a positive blood pregnancy test;
16. Plans to conceive within one year;
17. Having systemic diseases that are not effectively controlled;
18. Other conditions deemed unsuitable for participation in this clinical trial as evaluated by the investigator.