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)

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

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

Exclusion criteria

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

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