The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05935423
Recruitment Status : Not yet recruiting
First Posted : July 7, 2023
Last Update Posted : July 7, 2023
Sponsor:
Collaborator:
PT. Prodia Stem Cell Indonesia
Information provided by (Responsible Party):
dr. Dede Moeswir, Sp.PD, KKV, Indonesia University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment Phase
ST Elevation Myocardial Infarction Biological: Umbilical Cord Mesenchymal Stem Cell transplantation Phase 3

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intracoronary Allogenic Umbilical Cord Mesenchymal Stem Cell Reduce Infarct Size, Reverse Remodelling, and Improve Cardiac Function
Estimated Study Start Date : July 2023
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: UC-MSC
Patients assigned in UC-MSC intervention group will get Umbilical Cord Mesenchymal Stem Cell transplantation
 Biological: Umbilical Cord Mesenchymal Stem Cell transplantation
50 million UC MSC will be transplanted 10-15 days after primary PCI
No Intervention: Control
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Myocardial infarct size change [ Time Frame: 6 months ]
    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 :
  1. Left Ventricular Ejection Fraction (LVEF) with Echocardiography [ Time Frame: 6 months ]
    Left Ventricular Ejection Fraction (LVEF) measure with Echocardiography every month within 6 months after UC-MSC transplantation

  2. Left Ventricular Ejection Fraction (LVEF) with Cardiac MRI [ Time Frame: 6 months ]
    Left Ventricular Ejection Fraction (LVEF) measure with Cardiac MRI every month within 6 months after UC-MSC transplantation

  3. Major Cardiac Adverse Event (MACE) [ Time Frame: 6 months ]
    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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05935423


Contacts
Layout table for location contacts
Contact: Dede Moeswir +62 81287364648 dedemoeswir21@gmail.com

Locations
Layout table for location information
Indonesia
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, Indonesia
Sponsors and Collaborators
Indonesia University
PT. Prodia Stem Cell Indonesia
Investigators
Layout table for investigator information
Principal Investigator: Dede Moeswir Fakultas Kedokteran Universitas Indonesia
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

Layout table for additonal information
Responsible Party: dr. Dede Moeswir, Sp.PD, KKV, Principal Investigator, Indonesia University
ClinicalTrials.gov Identifier: NCT05935423    
Other Study ID Numbers: 23-02-0150
First Posted: July 7, 2023    Key Record Dates
Last Update Posted: July 7, 2023
Last Verified: July 2023

Layout table for additional information
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
Keywords provided by dr. Dede Moeswir, Sp.PD, KKV, Indonesia University:
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
 Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases