This study is designed to evaluate the safety and efficacy of allogeneic induced pluripotent cell derived cardiomyocytes (iPSC-CMs) in treating patients with worsening ischemic heart failure undergoing coronary artery bypass graft surgery. After screening, iPSC-CMs will be administrated intramyocardially in consented and eligible patients undergoing open-chest CABG surgery and the estimated population size for the study will be 32 patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
10-20 epicardial injections (0.25 mL each) of iPSC-CMs will be delivered in the border zone of the infarcted myocardium
The second xiangya hospital of central south university
Changsha, Hunan, China
RECRUITINGHelpThera
Nanjing, Jiangsu, China
NOT_YET_RECRUITINGSafety in terms of the incidence and severity of adverse events
Number of participants with death, fatal myocardial infarction, stroke, ventricular tachycardia sustained for \>15 seconds and newly formed tumor
Time frame: within 1 month post CABG surgery
Incidence of adverse events
Adverse events that require medical intervention
Time frame: 1~6 months post CABG surgery
Cardiac assessment
24-hour Holter Monitoring post the CABG surgery
Time frame: 1~6 months post CABG surgery
Incidence of newly formed tumor
Evaluation by chest, abdominal and pelvic CT scan and PET-CT scan
Time frame: 1~12 months post CABG surgery
Immunogenic assessments
Donor specific antibody (DSA), serum anti-human leukocyte antigens (anti-HLA) antibody/panel-reactive antibody (PRA) serology monitoring
Time frame: 1 month, 3 months and 6 months post CABG surgery
Changes in left ventricle function evaluation by echocardiogram (ECHO) or cardiac MRI
Changes in cardiac function will be assessed by left ventricular end-systolic volume (LVESV, mL) changes from baseline to 12 months post surgery
Time frame: from baseline to 12 months at 3, 6, and 12 months post CABG surgery
Changes in 6-minute walk test (6MWT)
Time frame: from baseline to 12 months at 1, 3, 6, and 12 months post CABG surgery
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Changes in NYHA functional classification
Time frame: from baseline to 12 months at 1, 3, 6, and 12 months post CABG surgery
Changes in quality of life (QoL)
Quality of life changes as measured by Minnesota Living with Heart Failure Questionnaire (MLHFQ) scores
Time frame: from baseline to 12 months at 1, 3, 6, and 12 months post CABG surgery
Incidence of hospitalization for worsening heart failure
Time frame: 1~12 months post CABG surgery