A Phase 1/2 interventional study of HiCM-188 therapy in Heart Failure, sponsored by HELP Therapeutics Co., Ltd.. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-10.
Sponsored by HELP Therapeutics Co., Ltd. · Phase 1/2, Interventional, and Treatment
The purpose of this clinical study is to evaluate the feasibility, safety and efficacy of intramyocardial injection of human induce pluripotent stem cell-derived cardiomyocytes (HiCM-188) during coronary artery bypass grafting (CABG) surgery in patients with severe chronic ischemic heart failure.
This is a single center, open-label, three-group dose-escalation (phase I) study followed by dose-extension (phase IIa) study in up to 36 severe ischemic heart failure patients. It is estimated that up to 18 phase I patients will be received HiCM-188 intramyocardial injection during CABG surgery. The maximum number of subjects after dose escalation and dose extension studies in each dose group is 12. All the subjects need take immunosuppressant after transplantation.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 36 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →HELP Therapeutics Co., Ltd. is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intramyocardial injection of HiCM-188 (50 million) during CABG surgery.
Drug: HiCM-188 therapy
Intramyocardial injection of HiCM-188 (150 million) during CABG surgery.
Drug: HiCM-188 therapy
Intramyocardial injection of HiCM-188 (450 million) during CABG surgery.
Drug: HiCM-188 therapy
Epicardial Injection of Allogeneic Human Pluripotent Stem Cell-derived Cardiomyocytes (HiCM-188) during coronary artery bypass grafting surgery
The incidence of major Serious Adverse Events (SAE)
The incidence of major Serious Adverse Events (SAE) within the first month after surgery, including pericardial tamponade, nonfatal myocardial infarction, stroke, and all-cause death
Time frame: Within the first month after surgery
Grade 4 or above arrhythmias Related to HiCM-188 Cell Therapy
Grade 4 or above arrhythmias associated with the HiCM-188 therapy within the first month after surgery
Time frame: Within the first month after surgery
The incidence of tumor
assessed by PET whole-body imaging at baseline and 12 months after HiCM-188 therapy
Time frame: 12 months after surgery
Left ventricular geometry as assessed by cardiac magnetic resonance imaging (MRI)
Left ventricular wall thickness, interventricular septum thickness
Time frame: Baseline, 6 and 12 months after surgery
Size of myocardial infarction as assessed by MRI
Size of myocardial infarction
Time frame: Baseline, 6 and 12 months after surgery
Ventricular wall motion as assessed by MRI
Ventricular wall motion
Time frame: Baseline, 6 and 12 months after surgery
Left ventricular ejection fraction as assessed by MRI
Left ventricular ejection fraction
Time frame: Baseline, 6 and 12 months after surgery
Cardiac Volumes as assessed by MRI
Left ventricular end-diastolic volume (LVEDV), Left ventricular end-systolic volume (LVESV) and Stroke Volume (SV)
Time frame: Baseline, 6 and 12 months after surgery
Cardiac output (CO) as assessed by MRI
Cardiac output (CO)
Time frame: Baseline, 6 and 12 months after surgery
End-diastolic myocardial mass as assessed by MRI
End-diastolic myocardial mass
Time frame: Baseline, 6 and 12 months after surgery
Left ventricular ejection fraction (LVEF) as assessed by Echocardiography
Left ventricular ejection fraction
Time frame: Baseline, 6 and 12 months after surgery
Fractional shortening (FS) as assessed by Echocardiography
Fractional shortening
Time frame: Baseline, 6 and 12 months after surgery
Left ventricular dimensions as assessed by Echocardiography
Left ventricular end-diastolic diameter (LVEDD), left ventricular end-systolic diameter(LVESD)and left atrial diameter
Time frame: Baseline, 6 and 12 months after surgery
Cardiac Volumes as assessed by Echocardiography
Left ventricular end- diastolic volume (LVEDV) and Left ventricular end-systolic volume(LVESV)
Time frame: Baseline, 6 and 12 months after surgery
Mitral valve inflow spectrum(E/A) as assessed by Echocardiography
Mitral valve inflow spectrum (E/A)
Time frame: Baseline, 6 and 12 months after surgery
Longitudinal strain as assessed by Echocardiography
Longitudinal strain
Time frame: Baseline, 6 and 12 months after surgery
Myocardial viability as assessed by SPECT
Myocardial viability
Time frame: Baseline, 6 and 12 months after surgery
Myocardial blood flow as assessed by SPECT
Myocardial blood flow
Time frame: Baseline, 6 and 12 months after surgery
NT-proBNP Levels
The changes of NT-proBNP Levels
Time frame: Baseline, 6 and 12 months after surgery
6-minute walking distance
The changes of 6-minute walking distance at 6M and 12M after HiCM-188 therapy
Time frame: Baseline, 6 and 12 months after surgery
New York Heart Association (NYHA) functional classification
The changes of New York Heart Association (NYHA) functional classification at 6M and 12M after HiCM-188 therapy
Time frame: Baseline, 6 and 12 months after surgery
Changes of Quality of Life (QoL) as assessed by 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 higher scores reflect better health status.
Time frame: Baseline, 6 and 12 months after surgery
Changes of Quality of Life(QOL) as assessed by 36-Item Short Form Survey (SF-36)
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: Baseline, 6 and 12 months after surgery
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
HELP Therapeutics Co., Ltd.