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

Phase 3

Not yet recruiting

• Conditions: ST Elevation Myocardial Infarction
• Interventions: Biological: Umbilical Cord Mesenchymal Stem Cell transplantation

• Registration Number: NCT05935423
• Lead Sponsor: Indonesia University

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-05-28
• Status Verified: 2023-07
• Study Start: 2023-07
• Study First Submitted QC: 2023-07-05
• Last Update Submitted: 2023-07-05
• Study First Posted: 2023-07-07
• Last Update Posted: 2023-07-07
• Primary Completion: 2024-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UC-MSC	Umbilical Cord Mesenchymal Stem Cell transplantation	Patients assigned in UC-MSC intervention group will get Umbilical Cord Mesenchymal Stem Cell transplantation

Primary Outcome Measures

Name	Time	Method
Myocardial infarct size change	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Left Ventricular Ejection Fraction (LVEF) with Echocardiography	6 months	Left Ventricular Ejection Fraction (LVEF) measure with Echocardiography every month within 6 months after UC-MSC transplantation
Major Cardiac Adverse Event (MACE)	6 months	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
Left Ventricular Ejection Fraction (LVEF) with Cardiac MRI	6 months	Left Ventricular Ejection Fraction (LVEF) measure with Cardiac MRI every month within 6 months after UC-MSC transplantation

Trial Locations

Locations (1)

Cipto Mangunkusumo Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia