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Completed

NCT Number: NCT04340609

Stem Cell in Acute Myocardial Infarction

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.

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Key information

Conditions

Acute Myocardial Infarction

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

PT Prodia StemCell Indonesia

Jakarta, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mesenchymal stem cells

Biological

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

PT. Prodia Stem Cell Indonesia

Industry

Registry information

Official study title

Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy for Acute Myocardial Infarction

Acronym: AMI

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Apr 9, 2020
Registry last updated
Jun 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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