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RECRUITINGPhase 3INTERVENTIONAL

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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)

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form form. Who Should NOT Join This Trial: 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 conditions (where your immune system attacks your own body)s; 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

BIOLOGICAL

HiCM-188 therapy

Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) during coronary artery bypass grafting surgery

PROCEDURE

CABG surgery

Conventional coronary artery bypass grafting (CABG) surgery

Locations (1)

TEDA International Cardiovascular Hospital
Tianjin, Tianjin Municipality, China