Stem Cell in Acute Myocardial Infarction

Acute Myocardial Infarction Clinical Trial

— AMI  

Official title:

Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy for Acute Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04340609
• Other study ID #: CT/AMI/01/2019
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 11, 2019
• Est. completion date: April 8, 2022

Study information

• Verified date: June 2022
• Source: PT. Prodia Stem Cell Indonesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: April 8, 2022
• Est. primary completion date: April 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• 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.

Locations

Country	Name	City	State
Indonesia	PT Prodia StemCell Indonesia	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
PT. Prodia Stem Cell Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac events (MACE) endpoints of mortality	To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.	2 weeks after stem cell
Primary	Major adverse cardiac events (MACE) endpoints of mortality	To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.	3 months after stem cell
Primary	Major adverse cardiac events (MACE) endpoints of mortality	To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.	6 months after stem cell
Primary	Major adverse cardiac events (MACE) endpoints of mortality	To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.	12 months after stem cell
Primary	Re-infarction	To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.	2 weeks after stem cell
Primary	Re-infarction	To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.	3 months after stem cell
Primary	Re-infarction	To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.	6 months after stem cell
Primary	Re-infarction	To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.	12 months after stem cell
Primary	Target vessel revascularization (TVR)	To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.	2 weeks after stem cell
Primary	Target vessel revascularization (TVR)	To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.	3 months after stem cell
Primary	Target vessel revascularization (TVR)	To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.	6 months after stem cell
Primary	Target vessel revascularization (TVR)	To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.	12 months after stem cell
Primary	Heart failure hospitalization	To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.	2 weeks after stem cell
Primary	Heart failure hospitalization	To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.	3 months after stem cell
Primary	Heart failure hospitalization	To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.	6 months after stem cell
Primary	Heart failure hospitalization	To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.	12 months after stem cell
Secondary	Cardiac MRI	a test to see improvement in LVEF(%), improvement in regional function, improvement in perfusion, reduction of infarct size.	6 months after stem cell
Secondary	Cardiac MRI	a test to see improvement in LVEF (%), improvement in regional function, improvement in perfusion, reduction of infarct size.	12 months after stem cell
Secondary	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.	6 months after stem cell
Secondary	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.	12 months after stem cell
Secondary	Electrocardiography (ECG)	to detects cardiac (heart) abnormalities by measuring the electrical activity generated by the heart as it contracts	3 months after stem cell
Secondary	Electrocardiography (ECG)	to detects cardiac (heart) abnormalities by measuring the electrical activity generated by the heart as it contracts	6 months after stem cell
Secondary	Electrocardiography (ECG)	to detects cardiac (heart) abnormalities by measuring the electrical activity generated by the heart as it contracts	12 months after stem cell
Secondary	Wellness Parameter	hs-CRP, antioxidant, IL-6, IL-10, PA1, Fibrinogen	6 months after stem cell
Secondary	Laboratory Assessment	Haematology, Serum Chemistry, Cardiac Biomarker	12 months after stem cell