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| Name | Class |
|---|---|
| Second Xiangya Hospital of Central South University | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator |
| |
| Treatment | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HiCM-188 Chitosan Patch | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion and frequency of patients experiencing sustained ventricular tachycardia lasting more than 30 seconds | 1~6 Month Post-operation | |
| Incidence of allogeneic human-derived tumor formation | CT scan of the abdomen and pelvis | Baseline, 1, 3, 6 months post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in infarct size | Assessed by MRI | Baseline, 1, 3, 6, and 12 months post-operation |
| Change in regional left ventricular function | Assessed by MRI |
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Inclusion Criteria:
Age between 18 and 80 years (inclusive).
Willingness and ability to give written informed consent.
Chronic left ventricular dysfunction classified as Stage D (refractory end-stage heart failure) according to ACC staging criteria.
NYHA functional class III-IV despite optimized guideline-directed medical therapy for heart failure.
Indication for coronary artery bypass grafting (CABG), meeting one of the following anatomical criteria:
5.1 Class I Indications :
5.2 Class IIa Indication : Left ventricular dysfunction with substantial viable, akinetic but revascularizable myocardium, not covered by above Class I anatomical criteria.
Left ventricular ejection fraction (LVEF) ≤40% as measured by echocardiography or cardiac MRI within 6 months prior to enrollment (excluding measurements obtained within 1 month post-myocardial infarction).
Echocardiographic evidence of regional wall motion abnormalities (hypokinesis, akinesis, or presence of ventricular aneurysm).
Exclusion Criteria:
Patients meeting any of the following criteria are ineligible for study participation:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiaxian Wang, MD, PhD | Contact | +86-18565616060 | wangjx@helpsci.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Xiangya Hospital of Central South University | Changsha | China |
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| Blank Chitosan Patch | Drug | Patients receive standard CABG surgery plus epicardial application of two identical-appearing chitosan patches containing no HiCM-188 cells |
|
| Baseline, 1, 3, 6, and 12 months post-operation |
| Change in regional left ventricular wall thickness | Assessed by MRI | Baseline, 1, 3, 6, and 12 months post-operation |
| Change in left ventricular end-diastolic wall thickness | Assessed by both MRI and echocardiography | Baseline, 1, 3, 6, and 12 months post-operation |
| Change in left ventricular ejection fraction (LVEF) | Assessed by both MRI and echocardiography | Baseline, 1, 3, 6, and 12 months post-operation |
| Change in left ventricular end-diastolic volume (LVEDV) | Assessed by both MRI and echocardiography | Baseline, 1, 3, 6, and 12 months post-operation |
| Change in left ventricular end-systolic volume (LVESV) | Assessed by both MRI and echocardiography | Baseline, 1, 3, 6, and 12 months post-operation |
| Change in regional myocardial perfusion | Assessed by MRI | 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 | 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. | 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. | Baseline, 1, 3, 6, and 12 months post-operation |