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)
NCT: NCT07496372 ·
Status: NOT YET RECRUITING ·
Phase: Phase 3
· Sponsor: HELP Therapeutics Co., Ltd.
· Started: 2026-04-30
· Est. Completion: 2027-08-31
Official 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)
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: SINGLE
- Enrollment: 80 participants
Interventions
- 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
Primary Outcomes
- 6-minute walk distance (6MWD) (12 months after surgery)
Secondary Outcomes
- All-cause mortality and cardiovascular mortality (12 months after surgery)
- 6MWD (6 months after surgery)
- Change from baseline in the NYHA classification (12 months after surgery)
- Worsening heart failure (including events requiring hospitalization or emergency treatment due to worsening symptoms and signs of heart failure) (12 months after surgery)
- Change from baseline in the Minnesota Living with Heart Failure Questionnaire (MLHFQ) (12 months after surgery)
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AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.