Clinical trial NCT05935423: Umbilical Cord Mesenchymal Stem Cell Improve Cardiac Function on ST-elevation Myocardial Infarction (STEMI) Patients
Official title: Intracoronary Allogenic Umbilical Cord Mesenchymal Stem Cell Reduce Infarct Size, Reverse Remodelling, and Improve Cardiac Function
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: ST Elevation Myocardial Infarction
Keywords: Umbilical Cord Mesenchymal Stem Cell
ST Elevation Myocardial Infarction
Infarct Size
Left Ventricular Ejection Fraction
IL-10
VEGF
Galectin 3
GATA-4
Beclin 1
Major Cardiac Adverse Events
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: PT. Prodia Stem Cell Indonesia
First posted: 2023-07-07
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Myocardial infarct size change
timeFrame: 6 months
Secondary outcomes:
measure: Left Ventricular Ejection Fraction (LVEF) with Echocardiography
timeFrame: 6 months
measure: Left Ventricular Ejection Fraction (LVEF) with Cardiac MRI
timeFrame: 6 months
measure: Major Cardiac Adverse Event (MACE)
timeFrame: 6 months
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: DKI Jakarta
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Dede Moeswir
role: PRINCIPAL_INVESTIGATOR
References:
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