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)
HiCM-188 therapy: Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) during coronary artery bypass grafting surgery
CABG surgery: Conventional coronary artery bypass grafting (CABG) surgery
Study summary
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)
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
6-minute walk distance (6MWD) — 12 months after surgery
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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