search
Back to results

Stem Cell in Acute Myocardial Infarction (AMI)

Primary Purpose

Acute Myocardial Infarction

Status
Completed
Phase
Phase 1
Locations
Indonesia
Study Type
Interventional
Intervention
Mesenchymal Stem Cells
Sponsored by
PT. Prodia Stem Cell Indonesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Allogeneic Mesenchymal Stem Cells, Umbilical Cord Mesenchymal Stem Cells, Intravenous Mesenchymal Stem Cells, Intracoronary Mesenechymal Stem Cells

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • STEMI patients within 5 days after symptom onset of a first ST-segment elevation myocardial infarction
  • Have undergone successful percutaneous coronary intervention (PCI) with drug eluting stent implantation of the infarct-related artery and demonstrated hypokinesia or akinesia that involved more than two thirds of the LV anteroseptal, lateral, or inferior wall with LV ejection fraction of < 45% by echocardiography.
  • Ability to understand and provide signed informed consent, or have a designated legal guardian or spouse legally able and willing to make such decisions on the subject's behalf,
  • Willingness to attend all scheduled safety follow-up visits
  • Subjects need to have a specific criteria of having a single vessel disease (ostial or proximal LAD vessels) that caused extensive anterior infarction (EF <45).

Exclusion Criteria:

  • Hemodynamic instability as demonstrated by any of the following,
  • Requirement of intra-aortic balloon pump of left ventricular assist device,
  • Need for inotropic support (e.g. dopamine and/or dobutamine) for more than 36 hours for the maintenance of mean arterial blood pressure ≥ 60 mmHg,
  • Previous or current concomitant serious illnesses, such as cancer, hematological disorders (Hb < 10 g/dL, WBC < 4 or > 11x109/L, or platelets < 100x109/L), kidney failure (creatinine level > 2.5 mg/dL, or creatinine clearance < 30 cc/min), serious infection or any other co-morbidities that could impact patient's short-term survival, psychiatric illness, history of drug of alcohol abuse,
  • Prosthetic valves,
  • Hypertrophic or restrictive cardiomyopathy,
  • Women of child-bearing potential,
  • Inability to comply with the protocol,
  • Currently using implantable electronic defibrillator or pacemaker

Sites / Locations

  • PT Prodia StemCell Indonesia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Intravenous Group

Intracoronary Group

Control Group

Arm Description

Dosage of intravenous route is 2 million MSCs/kg for each subject.

Dosage of intracoronary route is ±50 million MSCs for each subject.

Standard treatment of acute myocardia infarction

Outcomes

Primary Outcome Measures

Major adverse cardiac events (MACE) endpoints of mortality
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Major adverse cardiac events (MACE) endpoints of mortality
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Major adverse cardiac events (MACE) endpoints of mortality
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Major adverse cardiac events (MACE) endpoints of mortality
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Re-infarction
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Re-infarction
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Re-infarction
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Re-infarction
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Target vessel revascularization (TVR)
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Target vessel revascularization (TVR)
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Target vessel revascularization (TVR)
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Target vessel revascularization (TVR)
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Heart failure hospitalization
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Heart failure hospitalization
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Heart failure hospitalization
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Heart failure hospitalization
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.

Secondary Outcome Measures

Cardiac MRI
a test to see improvement in LVEF(%), improvement in regional function, improvement in perfusion, reduction of infarct size.
Cardiac MRI
a test to see improvement in LVEF (%), improvement in regional function, improvement in perfusion, reduction of infarct size.
Echocardiography
Left ventricular volumes will be determined at end-diastole and end-systole by quantitative biplane assessment. Endocardial borders will be manually traced from apical four-chamber and two-chamber views. Left ventricular volumes will be used to calculate ejection fraction using the biplane modified Simpson's summation-of-disks method recommended by the American Society of Echocardiography.
Echocardiography
Left ventricular volumes will be determined at end-diastole and end-systole by quantitative biplane assessment. Endocardial borders will be manually traced from apical four-chamber and two-chamber views. Left ventricular volumes will be used to calculate ejection fraction using the biplane modified Simpson's summation-of-disks method recommended by the American Society of Echocardiography.
Electrocardiography (ECG)
to detects cardiac (heart) abnormalities by measuring the electrical activity generated by the heart as it contracts
Electrocardiography (ECG)
to detects cardiac (heart) abnormalities by measuring the electrical activity generated by the heart as it contracts
Electrocardiography (ECG)
to detects cardiac (heart) abnormalities by measuring the electrical activity generated by the heart as it contracts
Wellness Parameter
hs-CRP, antioxidant, IL-6, IL-10, PA1, Fibrinogen
Laboratory Assessment
Haematology, Serum Chemistry, Cardiac Biomarker

Full Information

First Posted
February 8, 2020
Last Updated
June 12, 2022
Sponsor
PT. Prodia Stem Cell Indonesia
search

1. Study Identification

Unique Protocol Identification Number
NCT04340609
Brief Title
Stem Cell in Acute Myocardial Infarction
Acronym
AMI
Official Title
Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy for Acute Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
March 11, 2019 (Actual)
Primary Completion Date
April 8, 2021 (Actual)
Study Completion Date
April 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
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 study will perform UC-MSCs transplantation in 2 groups and 1 control group with standard treatment. Each group consists of 5 subjects. In the first group UC-MSCs will be transplanted via intravenous (IV) route and the second group via intracoronary (IC) route. The IV group will receive 2 million cells/kg for each subject and the dosage of IC group is 50 million cells for each subject. All groups will be observed until 1 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Allogeneic Mesenchymal Stem Cells, Umbilical Cord Mesenchymal Stem Cells, Intravenous Mesenchymal Stem Cells, Intracoronary Mesenechymal Stem Cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravenous Group
Arm Type
Experimental
Arm Description
Dosage of intravenous route is 2 million MSCs/kg for each subject.
Arm Title
Intracoronary Group
Arm Type
Experimental
Arm Description
Dosage of intracoronary route is ±50 million MSCs for each subject.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Standard treatment of acute myocardia infarction
Intervention Type
Biological
Intervention Name(s)
Mesenchymal Stem Cells
Intervention Description
The UC-MSCs from a donor will be cultured in a clinical grade laboratory with xeno-free medium. Maximum passage of expanded-UC MSCs was VI and doubling population is less than 30. To assure the quality of our expanded-UC MSCs at ProSTEM the following tests are done: cell adherence, cell surface marker, in vitro differentiation, cell viability, sterility, Mycoplasma, endotoxin, and karyotyping.
Primary Outcome Measure Information:
Title
Major adverse cardiac events (MACE) endpoints of mortality
Description
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Time Frame
2 weeks after stem cell
Title
Major adverse cardiac events (MACE) endpoints of mortality
Description
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Time Frame
3 months after stem cell
Title
Major adverse cardiac events (MACE) endpoints of mortality
Description
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Time Frame
6 months after stem cell
Title
Major adverse cardiac events (MACE) endpoints of mortality
Description
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Time Frame
12 months after stem cell
Title
Re-infarction
Description
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Time Frame
2 weeks after stem cell
Title
Re-infarction
Description
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Time Frame
3 months after stem cell
Title
Re-infarction
Description
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Time Frame
6 months after stem cell
Title
Re-infarction
Description
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Time Frame
12 months after stem cell
Title
Target vessel revascularization (TVR)
Description
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Time Frame
2 weeks after stem cell
Title
Target vessel revascularization (TVR)
Description
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Time Frame
3 months after stem cell
Title
Target vessel revascularization (TVR)
Description
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Time Frame
6 months after stem cell
Title
Target vessel revascularization (TVR)
Description
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Time Frame
12 months after stem cell
Title
Heart failure hospitalization
Description
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Time Frame
2 weeks after stem cell
Title
Heart failure hospitalization
Description
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Time Frame
3 months after stem cell
Title
Heart failure hospitalization
Description
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Time Frame
6 months after stem cell
Title
Heart failure hospitalization
Description
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Time Frame
12 months after stem cell
Secondary Outcome Measure Information:
Title
Cardiac MRI
Description
a test to see improvement in LVEF(%), improvement in regional function, improvement in perfusion, reduction of infarct size.
Time Frame
6 months after stem cell
Title
Cardiac MRI
Description
a test to see improvement in LVEF (%), improvement in regional function, improvement in perfusion, reduction of infarct size.
Time Frame
12 months after stem cell
Title
Echocardiography
Description
Left ventricular volumes will be determined at end-diastole and end-systole by quantitative biplane assessment. Endocardial borders will be manually traced from apical four-chamber and two-chamber views. Left ventricular volumes will be used to calculate ejection fraction using the biplane modified Simpson's summation-of-disks method recommended by the American Society of Echocardiography.
Time Frame
6 months after stem cell
Title
Echocardiography
Description
Left ventricular volumes will be determined at end-diastole and end-systole by quantitative biplane assessment. Endocardial borders will be manually traced from apical four-chamber and two-chamber views. Left ventricular volumes will be used to calculate ejection fraction using the biplane modified Simpson's summation-of-disks method recommended by the American Society of Echocardiography.
Time Frame
12 months after stem cell
Title
Electrocardiography (ECG)
Description
to detects cardiac (heart) abnormalities by measuring the electrical activity generated by the heart as it contracts
Time Frame
3 months after stem cell
Title
Electrocardiography (ECG)
Description
to detects cardiac (heart) abnormalities by measuring the electrical activity generated by the heart as it contracts
Time Frame
6 months after stem cell
Title
Electrocardiography (ECG)
Description
to detects cardiac (heart) abnormalities by measuring the electrical activity generated by the heart as it contracts
Time Frame
12 months after stem cell
Title
Wellness Parameter
Description
hs-CRP, antioxidant, IL-6, IL-10, PA1, Fibrinogen
Time Frame
6 months after stem cell
Title
Laboratory Assessment
Description
Haematology, Serum Chemistry, Cardiac Biomarker
Time Frame
12 months after stem cell

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: STEMI patients within 5 days after symptom onset of a first ST-segment elevation myocardial infarction Have undergone successful percutaneous coronary intervention (PCI) with drug eluting stent implantation of the infarct-related artery and demonstrated hypokinesia or akinesia that involved more than two thirds of the LV anteroseptal, lateral, or inferior wall with LV ejection fraction of < 45% by echocardiography. Ability to understand and provide signed informed consent, or have a designated legal guardian or spouse legally able and willing to make such decisions on the subject's behalf, Willingness to attend all scheduled safety follow-up visits Subjects need to have a specific criteria of having a single vessel disease (ostial or proximal LAD vessels) that caused extensive anterior infarction (EF <45). Exclusion Criteria: Hemodynamic instability as demonstrated by any of the following, Requirement of intra-aortic balloon pump of left ventricular assist device, Need for inotropic support (e.g. dopamine and/or dobutamine) for more than 36 hours for the maintenance of mean arterial blood pressure ≥ 60 mmHg, Previous or current concomitant serious illnesses, such as cancer, hematological disorders (Hb < 10 g/dL, WBC < 4 or > 11x109/L, or platelets < 100x109/L), kidney failure (creatinine level > 2.5 mg/dL, or creatinine clearance < 30 cc/min), serious infection or any other co-morbidities that could impact patient's short-term survival, psychiatric illness, history of drug of alcohol abuse, Prosthetic valves, Hypertrophic or restrictive cardiomyopathy, Women of child-bearing potential, Inability to comply with the protocol, Currently using implantable electronic defibrillator or pacemaker
Facility Information:
Facility Name
PT Prodia StemCell Indonesia
City
Jakarta
Country
Indonesia

12. IPD Sharing Statement

Learn more about this trial

Stem Cell in Acute Myocardial Infarction

We'll reach out to this number within 24 hrs