Injection of lab-grown heart muscle cells (HiCM-188) during bypass surgery for advanced heart failure
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)
This trial tests whether injecting HiCM-188 (human iPSC-derived cardiomyocytes) into the heart during coronary bypass helps adults 18–75 with advanced ischemic heart failure (NYHA III–IV and LVEF ≤35%).
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | HELP Therapeutics Co., Ltd. Industry-sponsored |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT07496372 on ClinicalTrials.gov |
What this trial studies
REVIVE-HEART is a multicenter, randomized, controlled Phase 3 trial comparing standard coronary artery bypass grafting (CABG) alone versus CABG plus intramyocardial injection of 150 million HiCM-188 cells. The cells are injected around the infarcted myocardium and participants receive postoperative immunosuppressive therapy to prevent rejection. Patients are followed for safety and efficacy outcomes up to 12 months after treatment. The trial enrolls adults with ischemic heart failure on maximal guideline-directed medical therapy and reduced ejection fraction confirmed by cardiac MRI.
Who should consider this trial
Good fit: Ideal candidates are adults 18–75 with ischemic heart failure NYHA class III–IV, LVEF ≤35% by cardiac MRI, on maximal guideline-directed medical therapy, and who are candidates for CABG surgery.
Not a fit: Patients unlikely to benefit include those with nonischemic causes (e.g., amyloidosis, acute myocarditis), recent MI (≤3 months), severe renal dysfunction (eGFR <35 ml/min/1.73m²), autoimmune disease, those expected to undergo transplant, or those unable to undergo the required surgery or follow-up testing.
Why it matters
Potential benefit: If successful, the approach could improve heart function, reduce symptoms and hospitalizations, and delay progression in people with advanced ischemic heart failure.
How similar studies have performed: Cell therapy approaches for heart failure have shown mixed results in humans, and iPSC-derived cardiomyocyte injections are relatively novel with promising preclinical data but limited large-scale human success so far.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Tianjin, Tianjin Municipality
- TEDA International Cardiovascular Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.