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

Last updated: July 5, 2023
Sponsor: Indonesia University
Overall Status: Active - Not Recruiting

Phase

3

Condition

Coronary Artery Disease

Cardiac Disease

Heart Defect

Treatment

Umbilical Cord Mesenchymal Stem Cell transplantation

Clinical Study ID

NCT05935423
23-02-0150
  • Ages 30-70
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with STEMI treated with primary PCI maximum 12 hours after onset of chestpain

Exclusion

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

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Umbilical Cord Mesenchymal Stem Cell transplantation
Phase: 3
Study Start date:
July 01, 2023
Estimated Completion Date:
July 31, 2024

Study 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.

Connect with a study center

  • Cipto Mangunkusumo Hospital

    Jakarta Pusat, DKI Jakarta
    Indonesia

    Site Not Available

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