This clinical trial investigates the safety, feasibility, and therapeutic potential of a combined approach using HiCM-188 cardiomyocyte injection delivered intramyocardially alongside either LVAD implantation or CABG surgery in patients with advanced ischemic heart failure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
CABG+0.5×10\^8 iPSC-CMs
CABG+1.5×10\^8 iPSC-CMs or LVAD+1.5×10\^8 iPSC-CMs
CABG/LVAD+Saline
HelpThera
Nanjing, Jiangsu, China
6-minute walk test
Time frame: baseline, 1, 3, 6, 12 months post-operation
Major Adverse Cardiovascular Events
The composite endpoint events occurring during the prescribed postoperative follow-up period included cardiac death, non-fatal myocardial infarction, non-fatal stroke, and emergency target vessel revascularization (e.g., PCI or CABG), which was expressed as the percentage of subjects experiencing at least one of these events (%).
Time frame: From enrollment to the end of study at 12 months
Survival rate
Time frame: From enrollment to the end of study at 12 months
Left ventricular ejection fraction
Improvement of left ventricular ejection fraction assessed by ECHO
Time frame: baseline, 1, 3, 6, 12 months post-operation
Cardiac magnetic resonance detection index
Myocardial infarction size and Myocardial fibrosis assessed by MRI
Time frame: baseline, 1, 3, 6, 12 months post-operation
BNP
BNP levels are measured by venous blood samples
Time frame: baseline, 1, 3, 6, 12 months post-operation
SF-36
life quality assessed by SF-36 (The Short-Form-36 Health Survey). The SF-36 scale is a tool used to assess health-related quality of life, including eight dimensions: Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH). Each dimension has its unique scoring criteria, and the score range for each dimension is from 0 to 100 points. Higher scores indicate better health outcomes
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Time frame: baseline, 1, 3, 6, 12 months post-operation
KCCQ
Kansas City Cardiomyopathy Questionnaire, KCCQ is designed to assess the health status and quality of life of patients with heart failure. The score range is from 0 to 100 and higher scores reflect better health status and quality of life.
Time frame: baseline, 1, 3, 6, 12 months post-operation
Removal rate of LVAD
Percentage of subjects who had their Left Ventricular Assist Device (LVAD) successfully removed after surgery
Time frame: From enrollment to the end of study at 12 months