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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Sham Comparator | CABG combined with saline or LVAD combined with saline |
|
| Low Dose Group | Experimental | CABG combined with 0.5×10^8 iPSC-CMs |
|
| High dose group | Experimental | CABG combined with 1.5×10^8 iPSC-CMs or LVAD combined with 1.5×10^8 iPSC-CMs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low dose CABG+iPSC-CMs | Biological | CABG+0.5×10^8 iPSC-CMs |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 6-minute walk test | 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 (%). | From enrollment to the end of study at 12 months |
| Survival rate | From enrollment to the end of study at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular ejection fraction | Improvement of left ventricular ejection fraction assessed by ECHO | baseline, 1, 3, 6, 12 months post-operation |
| Cardiac magnetic resonance detection index | Myocardial infarction size and Myocardial fibrosis assessed by MRI |
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Inclusion Criteria:
Male or female aged 35-75 years (inclusive) at the time of signing the informed consent form.
Capable of understanding the informed consent form, voluntarily agreeing to participate in the trial, and signing the informed consent form.
Diagnosed with end-stage heart failure.
Receiving optimized medical therapy for heart failure, with New York Heart Association (NYHA) functional class III-IV.
Echocardiography demonstrating regional hypokinesia or akinesia of the ventricular wall.
Cardiac magnetic resonance imaging (MRI) confirming left ventricular ejection fraction (LVEF) ≤35%.
Myocardial perfusion-metabolism imaging with radionuclide indicating infarcted myocardium in the left anterior descending (LAD) artery territory.
Meets criteria for coronary artery bypass grafting (CABG) under cardiopulmonary bypass during screening and requires CABG surgery.
For patients enrolled in the LVAD implantation group, the following additional criteria must be met:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiaxian Wang, MD, PhD | Contact | +86-18565616060 | wangjx@helpsci.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yongfeng Shao, MD, PhD | Jiangsu Provincial People's Hospital (First Affiliated Hospital of Nanjing Medical University) | Principal Investigator |
| Liansheng Wang, MD, PhD | Jiangsu Provincial People's Hospital (First Affiliated Hospital of Nanjing Medical University) |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HelpThera | Nanjing | Jiangsu | 210000 | China |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| High dose CABG/LVAD+iPSC-CMs |
| Biological |
CABG+1.5×10^8 iPSC-CMs or LVAD+1.5×10^8 iPSC-CMs |
|
| CABG/LVAD+Saline | Other | CABG/LVAD+Saline |
|
| baseline, 1, 3, 6, 12 months post-operation |
| BNP | BNP levels are measured by venous blood samples | 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 | 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. | 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 | From enrollment to the end of study at 12 months |
| Principal Investigator |