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| Name | Class |
|---|---|
| TEDA International Cardiovascular Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HiCM-188 Low dose therapy | Experimental | Intramyocardial injection of HiCM-188 (50 million) during CABG surgery. |
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| HiCM-188 Medium dose therapy | Experimental | Intramyocardial injection of HiCM-188 (150 million) during CABG surgery. |
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| HiCM-188 High dose therapy | Experimental | Intramyocardial injection of HiCM-188 (450 million) during CABG surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HiCM-188 therapy | Drug | Epicardial Injection of Allogeneic Human Pluripotent Stem Cell-derived Cardiomyocytes (HiCM-188) during coronary artery bypass grafting surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within the first month after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within the first month after surgery |
| The incidence of tumor |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TEDA International Cardiovascular Hospital | Tianjin | Tianjin Municipality | 300457 | China |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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assessed by PET whole-body imaging at baseline and 12 months after HiCM-188 therapy
| 12 months after surgery |
| Left ventricular geometry as assessed by cardiac magnetic resonance imaging (MRI) | Left ventricular wall thickness, interventricular septum thickness | Baseline, 6 and 12 months after surgery |
| Size of myocardial infarction as assessed by MRI | Size of myocardial infarction | Baseline, 6 and 12 months after surgery |
| Ventricular wall motion as assessed by MRI | Ventricular wall motion | Baseline, 6 and 12 months after surgery |
| Left ventricular ejection fraction as assessed by MRI | Left ventricular ejection fraction | 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) | Baseline, 6 and 12 months after surgery |
| Cardiac output (CO) as assessed by MRI | Cardiac output (CO) | Baseline, 6 and 12 months after surgery |
| End-diastolic myocardial mass as assessed by MRI | End-diastolic myocardial mass | Baseline, 6 and 12 months after surgery |
| Left ventricular ejection fraction (LVEF) as assessed by Echocardiography | Left ventricular ejection fraction | Baseline, 6 and 12 months after surgery |
| Fractional shortening (FS) as assessed by Echocardiography | Fractional shortening | 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 | 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) | Baseline, 6 and 12 months after surgery |
| Mitral valve inflow spectrum(E/A) as assessed by Echocardiography | Mitral valve inflow spectrum (E/A) | Baseline, 6 and 12 months after surgery |
| Longitudinal strain as assessed by Echocardiography | Longitudinal strain | Baseline, 6 and 12 months after surgery |
| Myocardial viability as assessed by SPECT | Myocardial viability | Baseline, 6 and 12 months after surgery |
| Myocardial blood flow as assessed by SPECT | Myocardial blood flow | Baseline, 6 and 12 months after surgery |
| NT-proBNP Levels | The changes of NT-proBNP Levels | 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 | 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 | 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. | 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. | Baseline, 6 and 12 months after surgery |