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The study will perform UC-MSCs transplantation in 2 groups and 1 control group with standard treatment. Each group consists of 5 subjects. In the first group UC-MSCs will be transplanted via intravenous (IV) route and the second group via intracoronary (IC) route. The IV group will receive 2 million cells/kg for each subject and the dosage of IC group is 50 million cells for each subject. All groups will be observed until 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Group | Experimental | Dosage of intravenous route is 2 million MSCs/kg for each subject. |
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| Intracoronary Group | Experimental | Dosage of intracoronary route is ±50 million MSCs for each subject. |
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| Control Group | No Intervention | Standard treatment of acute myocardia infarction |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal Stem Cells | Biological | The UC-MSCs from a donor will be cultured in a clinical grade laboratory with xeno-free medium. Maximum passage of expanded-UC MSCs was VI and doubling population is less than 30. To assure the quality of our expanded-UC MSCs at ProSTEM the following tests are done: cell adherence, cell surface marker, in vitro differentiation, cell viability, sterility, Mycoplasma, endotoxin, and karyotyping. |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac events (MACE) endpoints of mortality | To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction. | 2 weeks after stem cell |
| Major adverse cardiac events (MACE) endpoints of mortality | To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction. | 3 months after stem cell |
| Major adverse cardiac events (MACE) endpoints of mortality | To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction. | 6 months after stem cell |
| Major adverse cardiac events (MACE) endpoints of mortality | To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction. | 12 months after stem cell |
| Re-infarction | To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction. | 2 weeks after stem cell |
| Re-infarction | To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction. | 3 months after stem cell |
| Re-infarction | To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction. | 6 months after stem cell |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac MRI | a test to see improvement in LVEF(%), improvement in regional function, improvement in perfusion, reduction of infarct size. | 6 months after stem cell |
| Cardiac MRI | a test to see improvement in LVEF (%), improvement in regional function, improvement in perfusion, reduction of infarct size. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PT Prodia StemCell Indonesia | Jakarta | Indonesia |
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| Re-infarction | To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction. | 12 months after stem cell |
| Target vessel revascularization (TVR) | To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction. | 2 weeks after stem cell |
| Target vessel revascularization (TVR) | To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction. | 3 months after stem cell |
| Target vessel revascularization (TVR) | To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction. | 6 months after stem cell |
| Target vessel revascularization (TVR) | To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction. | 12 months after stem cell |
| Heart failure hospitalization | To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction. | 2 weeks after stem cell |
| Heart failure hospitalization | To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction. | 3 months after stem cell |
| Heart failure hospitalization | To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction. | 6 months after stem cell |
| Heart failure hospitalization | To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction. | 12 months after stem cell |
| 12 months after stem cell |
| Echocardiography | Left ventricular volumes will be determined at end-diastole and end-systole by quantitative biplane assessment. Endocardial borders will be manually traced from apical four-chamber and two-chamber views. Left ventricular volumes will be used to calculate ejection fraction using the biplane modified Simpson's summation-of-disks method recommended by the American Society of Echocardiography. | 6 months after stem cell |
| Echocardiography | Left ventricular volumes will be determined at end-diastole and end-systole by quantitative biplane assessment. Endocardial borders will be manually traced from apical four-chamber and two-chamber views. Left ventricular volumes will be used to calculate ejection fraction using the biplane modified Simpson's summation-of-disks method recommended by the American Society of Echocardiography. | 12 months after stem cell |
| Electrocardiography (ECG) | to detects cardiac (heart) abnormalities by measuring the electrical activity generated by the heart as it contracts | 3 months after stem cell |
| Electrocardiography (ECG) | to detects cardiac (heart) abnormalities by measuring the electrical activity generated by the heart as it contracts | 6 months after stem cell |
| Electrocardiography (ECG) | to detects cardiac (heart) abnormalities by measuring the electrical activity generated by the heart as it contracts | 12 months after stem cell |
| Wellness Parameter | hs-CRP, antioxidant, IL-6, IL-10, PA1, Fibrinogen | 6 months after stem cell |
| Laboratory Assessment | Haematology, Serum Chemistry, Cardiac Biomarker | 12 months after stem cell |