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This study is an exploratory clinical study to observe the improvement of heart function before and after the treatment by human umbilical cord mesenchymal stem cells, and the purpose is to evaluate the safety and effectiveness of human umbilical cord mesenchymal stem cells in the treatment of heart failure. The study is a randomized parallel controlled study. Patients receive a review of which main content includes symptom improvement, cardiac function improvement, and adverse events.
This study is an exploratory clinical study to observe the improvement of heart function before and after the treatment by human umbilical cord mesenchymal stem cells, and the purpose is to evaluate the safety and effectiveness of human umbilical cord mesenchymal stem cells in the treatment of heart failure. The study is a randomized parallel controlled study. The research process is as follows: 1. Twenty eligible patients with ischemic heart disease were recruited, fully informed, and signed a consent form, and randomly divided into CABG group (n=10) or CABG + stem cell treatment group (n=10); 2. CABG was performed under general anesthesia in both groups. In the cell therapy group, 1×10^7 human umbilical cord Mesenchymal Stem Cells were injected to the edge of the myocardial infarction area at 20 points at the same time in CABG; 3. Use vasoactive drugs and antibiotics to prevent infection one week after surgery. After the operation, before discharge, 1 month, 3 months, 6 months, 12 months after discharge, and once a year thereafter, until the death of the patient. Patients receive a review of which main content includes symptom improvement, cardiac function improvement, and adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CABG with hUC-MSC treatment group | Experimental | In the CABG with hUC-MSC treatment group, 1×10^7 human umbilical cord Mesenchymal Stem Cells were injected to the edge of the myocardial infarction area at 20 points at the same time in CABG. |
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| CABG group | No Intervention | CABG was performed under general anesthesia. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic Human Umbilical Cord Mesenchymal Stem Cells | Biological | In CABG with hUC-MSC treatment group, 1×10^7 Human Umbilical Cord Mesenchymal Stem Cells were injected at the edge of the myocardial infarction area at 20 points at the same time in CABG |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular ejection fraction | The change in Left ventricular ejection fraction (LVEF) % after the operation | Day 0, Day 30, Day 90, Day 180, Day 360, Day 720 |
| Left ventricular end diastolic volume | The change in Left ventricular end diastolic volume (LVEDV) ml after the operation | Day 0, Day 30, Day 90, Day 180, Day 360, Day 720 |
| Left ventricular end systolic volume | The change in Left ventricular end systolic volume (LVESV) ml after the operation | Day 0, Day 30, Day 90, Day 180, Day 360, Day 720 |
| Stroke volume | The change in Stroke volume (SV) ml after the operation | Day 0, Day 30, Day 90, Day 180, Day 360, Day 720 |
| Left ventricular apex four-chamber end systolic diameter | The change in Left ventricular apex four-chamber end systolic diameter (LVESD) mm after the operation | Day 0, Day 30, Day 90, Day 180, Day 360, Day 720 |
| 6 minutes walking distance | The change in 6 minutes walking distance m after the operation | Day 0, Day 30, Day 90, Day 180, Day 360, Day 720 |
| Measure | Description | Time Frame |
|---|---|---|
| THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE (WHOQOL) -BREF | The change in THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE (WHOQOL) -BREF after the operation | Day 0, Day 30, Day 90, Day 180, Day 360, Day 720 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhongmin Liu, Doctor | Contact | +86-021-38804518 | liu.zhongmin@tongji.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhongmin Liu, Doctor | Shanghai East Hospital, Shanghai Tongji University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital, Shanghai Tongji University | Recruiting | Shanghai | Shanghai Municipality | 200120 | China |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D018487 | Ventricular Dysfunction, Left |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D018754 | Ventricular Dysfunction |
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