Overview
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)
Description
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.
Eligibility
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.
