NCT05935423

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ST Elevation Myocardial Infarction

Interventions

Type	Name	Description
BIOLOGICAL	Umbilical Cord Mesenchymal Stem Cell transplantation	50 million UC MSC will be transplanted 10-15 days after primary PCI

Timeline

• Start date: 2023-07-01
• Primary completion: 2024-07-01
• Completion: 2024-07-01
• First posted: 2023-07-07
• Last updated: 2023-07-07

Locations

1 site across 1 country: Indonesia