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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
50 million UC MSC will be transplanted 10-15 days after primary PCI
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, Indonesia
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.
Time frame: 6 months
Left Ventricular Ejection Fraction (LVEF) with Echocardiography
Left Ventricular Ejection Fraction (LVEF) measure with Echocardiography every month within 6 months after UC-MSC transplantation
Time frame: 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
Time frame: 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
Time frame: 6 months
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