Umbilical Cord Mesenchymal Stem Cell Improve Cardiac Function on ST-elevation Myocardial Infarction (STEMI) Patients

Study Overview
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Brief Summary
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The goal of this clinical trial is to learn about the effectiveness of Umbilical Cord Mesenchymal Stem Cell (UC MSC) therapy in patients with STEMI against infarct myocardial size reduction and prevent the incidence of heart failure in the future

Detailed Description
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Participants who have already done Primary Percutaneous Coronary Intervention (PCI) will be informed about the procedure and risk of this clinical trial. After written consent, 60 participants will be check for their eligibility criteria and randomized into intervention (get UC MSC transplantation) and control group. All participants will be check for their biochemical blood analysis: Interleukin-10 (IL-10), Vascular Endothelial Growth Factor (VEGF), Galectin-3, GATA Binding Protein-4 (GATA-4), and Beclin 1 (1 day before transplantation, 7 dan 14 days after transplantation); infarct size and left ventricular ejection fraction (LVEF) through Cardiac MRI (7-10 days after Primary PCI and 6 months after transplantation) and echocardiography (every month); and major adverse cardiac events/MACE (every month). The result will be access after 6 months follow up.

Official Title
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Intracoronary Allogenic Umbilical Cord Mesenchymal Stem Cell Reduce Infarct Size, Reverse Remodelling, and Improve Cardiac Function

Conditions
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ST Elevation Myocardial Infarction

Intervention / Treatment
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* Biological: Umbilical Cord Mesenchymal Stem Cell transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with STEMI treated with primary PCI maximum 12 hours after onset of chest pain Exclusion Criteria: Patients with history of coronary artery bypass grafting surgery Patients with history of heart failure before admission Patients with cardiogenic shock Patients with cancer disease Patients with malignant arrythmia Patients with chronic kidney disease Patients with haemostasis disorder Patients with infection Patients with stroke

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UC-MSC<br>Patients assigned in UC-MSC intervention group will get Umbilical Cord Mesenchymal Stem Cell transplantation | Biological: Umbilical Cord Mesenchymal Stem Cell transplantation<br>* 50 million UC MSC will be transplanted 10-15 days after primary PCI<br>|
| No Intervention: Control<br>Patient assigned in control group doesn't get Umbilical Cord Mesenchymal Stem Cell transplantation. However, they will be fully treated based on European Society of Cardiology (ESC) guidelines | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial infarct size change | Myocardial infarct size change in percentage measure with Cardiac MRI 7-10 days after primary PCI to 6 months after UC-MSC transplantation. The method used by measuring the area of infarction in a series of slices and multiplying the area times the slice thickness to determine a volume. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left Ventricular Ejection Fraction (LVEF) with Echocardiography | Left Ventricular Ejection Fraction (LVEF) measure with Echocardiography every month within 6 months after UC-MSC transplantation | 6 months | 
| Left Ventricular Ejection Fraction (LVEF) with Cardiac MRI | Left Ventricular Ejection Fraction (LVEF) measure with Cardiac MRI every month within 6 months after UC-MSC transplantation | 6 months | 
| Major Cardiac Adverse Event (MACE) | Total death, recurrent myocardial infarction, revascularization with primary PCI or Coronary Artery Bypass Graft (CABG) surgery, stroke, rehospitalisation due to heart failure, haemorrhage and arrythmia malignant assess every months within 6 months after UC-MSC transplantation | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Umbilical Cord Mesenchymal Stem Cell, ST Elevation Myocardial Infarction, Infarct Size, Left Ventricular Ejection Fraction, IL-10, VEGF, Galectin 3, GATA-4, Beclin 1, Major Cardiac Adverse Events