This is an exploratory study. A total of 16 patients meeting the inclusion and exclusion criteria and awaiting coronary artery bypass grafting (CABG) surgery will be enrolled. After providing informed consent, participants will be randomized 1:1 under double-blind conditions into two groups: 1. CABG + HiCM-188-loaded chitosan patch group (patch size: 2×4 cm; containing 5 million cells per patch) 2. CABG + blank chitosan patch group (identical in appearance but without HiCM-188 cells). During CABG surgery, investigators will apply two HiCM-188-loaded chitosan patches onto the epicardial surface over regions of hypokinetic myocardium. The total transplanted cell dose per patient in the treatment group is 1 × 10⁷ . In the control group, eight patients will undergo identical surgical procedures with application of chitosan patches without HiCM-188 cells.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
Patients receive standard coronary artery bypass grafting (CABG) surgery plus epicardial application of two chitosan patches (each 2×4 cm in size, loaded with 5 million HiCM-188 cells), delivering a total dose of 1 × 10⁷ cardiomyocytes.
Patients receive standard CABG surgery plus epicardial application of two identical-appearing chitosan patches containing no HiCM-188 cells
The Second Xiangya Hospital of Central South University
Changsha, China
Proportion and frequency of patients experiencing sustained ventricular tachycardia lasting more than 30 seconds
Time frame: 1~6 Month Post-operation
Incidence of allogeneic human-derived tumor formation
CT scan of the abdomen and pelvis
Time frame: Baseline, 1, 3, 6 months post-operation
Change in infarct size
Assessed by MRI
Time frame: Baseline, 1, 3, 6, and 12 months post-operation
Change in regional left ventricular function
Assessed by MRI
Time frame: Baseline, 1, 3, 6, and 12 months post-operation
Change in regional left ventricular wall thickness
Assessed by MRI
Time frame: Baseline, 1, 3, 6, and 12 months post-operation
Change in left ventricular end-diastolic wall thickness
Assessed by both MRI and echocardiography
Time frame: Baseline, 1, 3, 6, and 12 months post-operation
Change in left ventricular ejection fraction (LVEF)
Assessed by both MRI and echocardiography
Time frame: Baseline, 1, 3, 6, and 12 months post-operation
Change in left ventricular end-diastolic volume (LVEDV)
Assessed by both MRI and echocardiography
Time frame: Baseline, 1, 3, 6, and 12 months post-operation
Change in left ventricular end-systolic volume (LVESV)
Assessed by both MRI and echocardiography
Time frame: Baseline, 1, 3, 6, and 12 months post-operation
Change in regional myocardial perfusion
Assessed by MRI
Time frame: Baseline, 1, 3, 6, and 12 months post-operation
Six-minute walk test
The distance a participant can walk on a flat, hard surface in 6 minutes
Time frame: Baseline, 1, 3, 6, and 12 months post-operation
New York Heart Association (NYHA) functional classification
A clinician-assessed 4-class scale (I-IV) evaluating symptom severity and functional limitation due to heart failure. Higher classes indicate greater impairment in physical activity tolerance.
Time frame: Baseline, 1, 3, 6, and 12 months post-operation
Minnesota Living with Heart Failure Questionnaire (MLHFQ) score
A 21-item patient-reported outcome measure assessing health-related quality of life specific to heart failure. Total score ranges from 0 (no impact) to 105 (severe impact). Lower scores reflect better quality of life.
Time frame: Baseline, 1, 3, 6, and 12 months post-operation
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