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| Name | Class |
|---|---|
| Central South University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose level 1 | Experimental | 100 million iPSC-CMs administration |
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| Dose level 2 | Experimental | 200 million iPSC-CMs administration |
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| Dose level 3 | Experimental | 400 million iPSC-CMs administration |
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| Control | No Intervention | Participants will received CABG surgery only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human (allogeneic) iPS-cell-derived cardiomyocyte | Biological | 10-20 epicardial injections (0.25 mL each) of iPSC-CMs will be delivered in the border zone of the infarcted myocardium |
| Measure | Description | Time Frame |
|---|---|---|
| Safety 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 | within 1 month post CABG surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Adverse events that require medical intervention | 1~6 months post CABG surgery |
| Cardiac assessment | 24-hour Holter Monitoring post the CABG surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiaxian Wang | 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 | Recruiting | Changsha | Hunan | 410000 | China |
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| 1~6 months post CABG surgery |
| Incidence of newly formed tumor | Evaluation by chest, abdominal and pelvic CT scan and PET-CT scan | 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 | 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 | from baseline to 12 months at 3, 6, and 12 months post CABG surgery |
| Changes in 6-minute walk test (6MWT) | from baseline to 12 months at 1, 3, 6, and 12 months post CABG surgery |
| Changes in NYHA functional classification | 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 | from baseline to 12 months at 1, 3, 6, and 12 months post CABG surgery |
| Incidence of hospitalization for worsening heart failure | 1~12 months post CABG surgery |
| HelpThera | Not yet recruiting | Nanjing | Jiangsu | 210000 | China |
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