Efficacy and Safety of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) in Advanced Heart Failure (NYHA Class III-IV)
Multicenter, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) in Advanced Heart Failure (NYHA Class III-IV)
HELP Therapeutics Co., Ltd.
80 participants
Apr 30, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria19
- 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.
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Interventions
Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) during coronary artery bypass grafting surgery
Conventional coronary artery bypass grafting (CABG) surgery
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07496372