Stem Cell in Acute Myocardial Infarction (AMI)

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

Tracking Information

• First Submitted Date: February 8, 2020
• First Posted Date: April 9, 2020
• Last Update Posted Date: June 14, 2022
• Actual Study Start Date: March 11, 2019
• Actual Primary Completion Date: April 8, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 7, 2020)

• 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.
• 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.
• 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.
• 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.
• Re-infarction [ Time Frame: 2 weeks after stem cell ]
  To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
• Re-infarction [ Time Frame: 3 months after stem cell ]
  To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
• Re-infarction [ Time Frame: 6 months after stem cell ]
  To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
• Re-infarction [ Time Frame: 12 months after stem cell ]
  To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
• 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.
• 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.
• 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.
• 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.
• Heart failure hospitalization [ Time Frame: 2 weeks after stem cell ]
  To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
• Heart failure hospitalization [ Time Frame: 3 months after stem cell ]
  To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
• Heart failure hospitalization [ Time Frame: 6 months after stem cell ]
  To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
• Heart failure hospitalization [ Time Frame: 12 months after stem cell ]
  To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 7, 2020)

• 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.
• 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.
• 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.
• 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.
• 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
• 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
• 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
• Wellness Parameter [ Time Frame: 6 months after stem cell ]
  hs-CRP, antioxidant, IL-6, IL-10, PA1, Fibrinogen
• Laboratory Assessment [ Time Frame: 12 months after stem cell ]
  Haematology, Serum Chemistry, Cardiac Biomarker

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Stem Cell in Acute Myocardial Infarction
• Official Title: Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy for Acute Myocardial Infarction
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Acute Myocardial Infarction

Intervention

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.

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 12, 2022): 4
• Original Estimated Enrollment (submitted: April 7, 2020): 15
• Actual Study Completion Date: April 8, 2022
• Actual Primary Completion Date: April 8, 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Indonesia

Administrative Information

• NCT Number: NCT04340609
• Other Study ID Numbers: CT/AMI/01/2019
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: PT. Prodia Stem Cell Indonesia
• Original Responsible Party: Same as current
• Current Study Sponsor: PT. Prodia Stem Cell Indonesia
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: PT. Prodia Stem Cell Indonesia
• Verification Date: June 2022