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

University of Indonesia (UI)

Status and phase: Not yet enrolling; Phase 3

Conditions: ST Elevation Myocardial Infarction

Treatments: Biological: Umbilical Cord Mesenchymal Stem Cell transplantation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05935423

23-02-0150

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

UC-MSC

Experimental group

Description:

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

Treatment:

Biological: Umbilical Cord Mesenchymal Stem Cell transplantation

Control

No Intervention group

Description:

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