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)
REVIVE-HEART is a multicenter, randomized, controlled, confirmatory clinical trial evaluating patients with advanced heart failure (NYHA III-IV). Participants were assigned to receive either conventional coronary artery bypass grafting (CABG) alone or CABG combined with HiCM-188 (150 million cells). The cells were administered via myocardial injections around the infarcted area, followed by postoperative immunosuppressive therapy. Efficacy and safety were assessed 12 months post-treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
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
TEDA International Cardiovascular Hospital
Tianjin, Tianjin Municipality, China
RECRUITING6-minute walk distance (6MWD)
Time frame: 12 months after surgery
All-cause mortality and cardiovascular mortality
Time frame: 12 months after surgery
6MWD
Time frame: 6 months after surgery
Change from baseline in the NYHA classification
Time frame: 12 months after surgery
Worsening heart failure (including events requiring hospitalization or emergency treatment due to worsening symptoms and signs of heart failure)
Time frame: 12 months after surgery
Change from baseline in the Minnesota Living with Heart Failure Questionnaire (MLHFQ)
The MLHFQ is a self-administered disease-specific outcome measure instrument for patients with heart failure (HF), comprising 21 items rated on Likert scales, representing different degrees of impact of HF on QoL. The MLHFQ scores are on a range of 0-105, in which lower scores reflect better health status.
Time frame: 12 months after surgery
Change from baseline in the SF-36 questionnaire
The 36-Item Short Form Survey(SF-36) is a self-administered outcome measure instrument that comprises 36 items grouped into 8 dimensions: limitations in physical activities because of health problems, limitations in social activities because of physical or emotional problems, limitations in usual role activities because of physical health problems, bodily pain, general mental health, limitations in usual role activities because of emotional problems, vitality, general health perceptions. The SF-36 scores are on a range of 0-100, in which higher scores reflect better health status.
Time frame: 12 months after surgery
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Myocardial blood flow as assessed by SPECT
Time frame: 12 months after surgery
Myocardial viability as assessed by SPECT
Time frame: 12 months after surgery
Left ventricular ejection fraction as assessed by MRI
Left ventricular ejection fraction
Time frame: 12 months after surgery
Cardiac Volumes as assessed by MRI
Left ventricular end-diastolic volume index (LVEDVi), Left ventricular end-systolic volume index (LVESVi) and Stroke Volume (SV)
Time frame: 12 months after surgery
Scar size as assessed by MRI
Time frame: 12 months after surgery
Change from baseline in NT-proBNP level
Time frame: 12 months after surgery
Tumor markers abnormally elevated compared to baseline
Time frame: 12 months after surgery
Other AEs
Time frame: 12 months after surgery