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)
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Biological
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
TEDA International Cardiovascular Hospital
RECRUITING
Tianjin
Time Frame
Start Date: 2026-04-30
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 80
Treatments
Active_comparator: Control group
Coronary artery bypass grafting surgery
Experimental: Experimental group
Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) during coronary artery bypass grafting surgery
Related Therapeutic Areas
Sponsors
Leads: HELP Therapeutics Co., Ltd.