Severe chronic ischemic heart failure
Conditions
Interventions
Dose 1:Epicardial Injection of Allogeneic Human Pluripotent Stem Cell-derived Cardiomyocytes (HiCM-188) at a dose of 50 million HiCM-188 Cells undergoing cor
Dose 3:Epicardial Injection of Allogeneic Human Pluripotent Stem Cell-derived Cardiomyocytes (HiCM-188) at a dose of 450 million HiCM-188 Cells undergoing co
Dose 2:Epicardial Injection of Allogeneic Human Pluripotent Stem Cell-derived Cardiomyocytes (HiCM-188) at a dose of 150 million HiCM-188 Cells undergoing co
Sponsors
Chinese Academy of Medical Sciences Peking Union Medical College TEDA International Cardiovascular Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >=18 years; 2.Willingness and ability to give written informed consent; 3.Nuclide-myocardial metabolic perfusion imaging or Magnetic Resonance Imaging (MRI) revealed infarcted myocardium in the left anterior descending branch (LAD) coronary artery supply area; 4.LVEF<50% as assessed by Echocardiography or LVEF <= 40% as assessed by MRI; 5.Patients have indications for Coronary Artery Bypass Grafting;
Exclusion criteria
Exclusion criteria: 1.Presence of a pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy device (CRT); 2.Diagnosed with malignancy within 5 years; 3.Autoimmune disease; 4.Recipients of organ transplant. 5.Patients undergoing other surgical operations (excluding resection of ventricular aneurysm and left atrial appendage excision/occlusion). 6.Severe ventricular arrhythmia; 7.Contraindication to CABG surgery; 8.Contraindication to cardiac MRI or PET/CT scan. 9.Contraindication to immunosuppressants; 10.Participation in another clinical trial within 3 months prior to screening; 11.Pregnancy, lactation, or a positive serum pregnancy test; 12.Any other condition considered by the investigator to be inappropriate for inclusion in this clinical trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of major Serious Adverse Events, including Pericardial tamponade, Non-fatal myocardial infarction, Stroke, All-cause mortality; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of tumor;Grade 4 or above arrhythmias Related to HiCM-188 Cell Therapy;Left ventricular end-diastolic/systolic volume as assessed by cardiac magnetic resonance imaging (MRI);Fractional shortening (FS) as assessed by Echocardiography;Longitudinal strain as assessed by Echocardiography;Left ventricular end diastolic/systolic volume as assessed by Echocardiography;New York Heart Association (NYHA) functional classification;Ventricular wall motion as assessed by MRI;Myocardial blood flow;Stroke Volumes as assessed by MRI;End-diastolic myocardial mass as assessed by MRI;Left ventricular end-diastolic/systolic diameter as assessed by Echocardiography;Mitral valve inflow spectrum(E/A) as assessed by Echocardiography;Changes of Quality of Life (QoL) as assessed by Minnesota Living with Heart Failure Questionnaire;Left ventricular septal thickness as assessed by MRI;6-minute walking distance;Coronary flow reserve (CFR);NT-proBNP Levels;Left atrial diameter as assessed by Echocardiography;Cardiac output as assessed by MRI;Myocardial viability;Changes of Quality of Life (QoL) as assessed by 36-Item Short Form Survey;Left ventricular ejection fraction (LVEF) as assessed by Echocardiography;Size of myocardial infarction as assessed by MRI;Left ventricular wall thickness as assessed by MRI;Left ventricular ejection fraction as assessed by MRI; | — |
Countries
China
Contacts
Public ContactLiuxiao Cheng
Chinese Academy of Medical Sciences Peking Union Medical College TEDA International Cardiovascular Hospital
Outcome results
None listed