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Stem Cell in Acute Myocardial Infarction (AMI)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04340609
Recruitment Status : Completed
First Posted : April 9, 2020
Last Update Posted : June 14, 2022
Sponsor:
Information provided by (Responsible Party):
PT. Prodia Stem Cell Indonesia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Biological: Mesenchymal Stem Cells Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy for Acute Myocardial Infarction
Actual Study Start Date : March 11, 2019
Actual Primary Completion Date : April 8, 2021
Actual Study Completion Date : April 8, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intravenous Group
Dosage of intravenous route is 2 million MSCs/kg for each subject.
 Biological: Mesenchymal Stem Cells
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.
Experimental: Intracoronary Group
Dosage of intracoronary route is ±50 million MSCs for each subject.
 Biological: Mesenchymal Stem Cells
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.
No Intervention: Control Group
Standard treatment of acute myocardia infarction


Outcome Measures
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Primary Outcome Measures :
  1. Major adverse cardiac events (MACE) endpoints of mortality [ Time Frame: 2 weeks after stem cell ]
    To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.

  2. Major adverse cardiac events (MACE) endpoints of mortality [ Time Frame: 3 months after stem cell ]
    To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.

  3. Major adverse cardiac events (MACE) endpoints of mortality [ Time Frame: 6 months after stem cell ]
    To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.

  4. Major adverse cardiac events (MACE) endpoints of mortality [ Time Frame: 12 months after stem cell ]
    To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.

  5. Re-infarction [ Time Frame: 2 weeks after stem cell ]
    To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.

  6. Re-infarction [ Time Frame: 3 months after stem cell ]
    To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.

  7. Re-infarction [ Time Frame: 6 months after stem cell ]
    To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.

  8. Re-infarction [ Time Frame: 12 months after stem cell ]
    To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.

  9. Target vessel revascularization (TVR) [ Time Frame: 2 weeks after stem cell ]
    To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.

  10. Target vessel revascularization (TVR) [ Time Frame: 3 months after stem cell ]
    To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.

  11. Target vessel revascularization (TVR) [ Time Frame: 6 months after stem cell ]
    To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.

  12. Target vessel revascularization (TVR) [ Time Frame: 12 months after stem cell ]
    To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.

  13. Heart failure hospitalization [ Time Frame: 2 weeks after stem cell ]
    To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.

  14. Heart failure hospitalization [ Time Frame: 3 months after stem cell ]
    To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.

  15. Heart failure hospitalization [ Time Frame: 6 months after stem cell ]
    To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.

  16. Heart failure hospitalization [ Time Frame: 12 months after stem cell ]
    To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.


Secondary Outcome Measures :
  1. Cardiac MRI [ Time Frame: 6 months after stem cell ]
    a test to see improvement in LVEF(%), improvement in regional function, improvement in perfusion, reduction of infarct size.

  2. Cardiac MRI [ Time Frame: 12 months after stem cell ]
    a test to see improvement in LVEF (%), improvement in regional function, improvement in perfusion, reduction of infarct size.

  3. Echocardiography [ Time Frame: 6 months after stem cell ]
    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.

  4. Echocardiography [ Time Frame: 12 months after stem cell ]
    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.

  5. Electrocardiography (ECG) [ Time Frame: 3 months after stem cell ]
    to detects cardiac (heart) abnormalities by measuring the electrical activity generated by the heart as it contracts

  6. Electrocardiography (ECG) [ Time Frame: 6 months after stem cell ]
    to detects cardiac (heart) abnormalities by measuring the electrical activity generated by the heart as it contracts

  7. Electrocardiography (ECG) [ Time Frame: 12 months after stem cell ]
    to detects cardiac (heart) abnormalities by measuring the electrical activity generated by the heart as it contracts

  8. Wellness Parameter [ Time Frame: 6 months after stem cell ]
    hs-CRP, antioxidant, IL-6, IL-10, PA1, Fibrinogen

  9. Laboratory Assessment [ Time Frame: 12 months after stem cell ]
    Haematology, Serum Chemistry, Cardiac Biomarker


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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): NCT04340609


Locations
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Indonesia
PT Prodia StemCell Indonesia
Jakarta, Indonesia
Sponsors and Collaborators
PT. Prodia Stem Cell Indonesia
More Information
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Responsible Party: PT. Prodia Stem Cell Indonesia
ClinicalTrials.gov Identifier: NCT04340609    
Other Study ID Numbers: CT/AMI/01/2019
First Posted: April 9, 2020    Key Record Dates
Last Update Posted: June 14, 2022
Last Verified: June 2022

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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 PT. Prodia Stem Cell Indonesia:
Allogeneic Mesenchymal Stem Cells
Umbilical Cord Mesenchymal Stem Cells
Intravenous Mesenchymal Stem Cells
Intracoronary Mesenechymal Stem Cells
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases