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

Primary Purpose

ST Elevation Myocardial Infarction

Status
Not yet recruiting
Phase
Phase 3
Locations
Indonesia
Study Type
Interventional
Intervention
Umbilical Cord Mesenchymal Stem Cell transplantation
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST Elevation Myocardial Infarction focused on measuring 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

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cipto Mangunkusumo Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

UC-MSC

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Myocardial infarct size change
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

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

Full Information

First Posted
May 28, 2023
Last Updated
July 5, 2023
Sponsor
Indonesia University
Collaborators
PT. Prodia Stem Cell Indonesia
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1. Study Identification

Unique Protocol Identification Number
NCT05935423
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
Collaborators
PT. Prodia Stem Cell Indonesia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UC-MSC
Arm Type
Experimental
Arm Description
Patients assigned in UC-MSC intervention group will get Umbilical Cord Mesenchymal Stem Cell transplantation
Arm Title
Control
Arm Type
No Intervention
Arm 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
Intervention Type
Biological
Intervention Name(s)
Umbilical Cord Mesenchymal Stem Cell transplantation
Intervention Description
50 million UC MSC will be transplanted 10-15 days after primary PCI
Primary Outcome Measure Information:
Title
Myocardial infarct size change
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Left Ventricular Ejection Fraction (LVEF) with Echocardiography
Description
Left Ventricular Ejection Fraction (LVEF) measure with Echocardiography every month within 6 months after UC-MSC transplantation
Time Frame
6 months
Title
Left Ventricular Ejection Fraction (LVEF) with Cardiac MRI
Description
Left Ventricular Ejection Fraction (LVEF) measure with Cardiac MRI every month within 6 months after UC-MSC transplantation
Time Frame
6 months
Title
Major Cardiac Adverse Event (MACE)
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dede Moeswir
Phone
+62 81287364648
Email
dedemoeswir21@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dede Moeswir
Organizational Affiliation
Fakultas Kedokteran Universitas Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cipto Mangunkusumo Hospital
City
Jakarta Pusat
State/Province
DKI Jakarta
Country
Indonesia

12. IPD Sharing Statement

Citations:
PubMed Identifier
30029992
Citation
Terashvili M, Bosnjak ZJ. Stem Cell Therapies in Cardiovascular Disease. J Cardiothorac Vasc Anesth. 2019 Jan;33(1):209-222. doi: 10.1053/j.jvca.2018.04.048. Epub 2018 Apr 26.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
26339251
Citation
Shen H, Wang Y, Zhang Z, Yang J, Hu S, Shen Z. Mesenchymal Stem Cells for Cardiac Regenerative Therapy: Optimization of Cell Differentiation Strategy. Stem Cells Int. 2015;2015:524756. doi: 10.1155/2015/524756. Epub 2015 Aug 3.
Results Reference
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PubMed Identifier
19085935
Citation
Llano R, Epstein S, Zhou R, Zhang H, Hamamdzic D, Keane MG, Freyman T, Wilensky RL. Intracoronary delivery of mesenchymal stem cells at high flow rates after myocardial infarction improves distal coronary blood flow and decreases mortality in pigs. Catheter Cardiovasc Interv. 2009 Feb 1;73(2):251-7. doi: 10.1002/ccd.21781.
Results Reference
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PubMed Identifier
33304934
Citation
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Results Reference
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PubMed Identifier
19383393
Citation
Timmers L, Lim SK, Arslan F, Armstrong JS, Hoefer IE, Doevendans PA, Piek JJ, El Oakley RM, Choo A, Lee CN, Pasterkamp G, de Kleijn DP. Reduction of myocardial infarct size by human mesenchymal stem cell conditioned medium. Stem Cell Res. 2007 Nov;1(2):129-37. doi: 10.1016/j.scr.2008.02.002. Epub 2008 Mar 8.
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Citation
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Links:
URL
https://www.nature.com/articles/ncpcardio0417
Description
Timing of intracoronary bone-marrow-derived stem cell transplantation after ST-elevation myocardial infarction.
URL
https://jkms.org/pdf/10.3346/jkms.2014.29.1.23
Description
A randomized, open-label, multicenter trial for the safety and efficacy of adult mesenchymal stem cells after acute myocardial infarction.

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

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