Heart Patch for Myocardial Infarction COVID-19

Study Overview
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Brief Summary
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Myocardial infarction (MI), as one of the many complications of COVID-19, is one of the contributing patients of patients' death. This study attempts on developing an intervention of MI by regenerating damaged cardiomyocytes due to insufficiency of oxygen in cardiac muscles, triggered by an occlusion of coronary artery (MI). Heart patch developed from amnion bilayer seeded with amnion epithelial stem cells and patient's autologous cardiomyocytes is used as a therapy. Patients who undergo bypass (CABG) surgery are given heart patch, and then patients condition are observed by ECG, Echo, blood test, and radiology (technetium-99m)

Official Title
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Targeted-cell Therapy Using Epithelial Stem Cells and Patients' Cardiomyocytes Loaded in Amnion Bilayer to Regenerate Myocardial Infarction Post COVID-19 Complication

Conditions
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Myocardial Infarction, Heart Diseases

Intervention / Treatment
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* Device: Heart patch seeded with autologous cardiomyocytes and amnion epithelial stem cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 40 - 60 years old Ischemic burden >10% and ischemic gradients red-violet Ischemic area is not feasible to be grafted (bypass) due to other conditions such as diffusion and deep intramuscular vascularization Ejection fraction >30-35% Euro score <8 Exclusion Criteria: Scanning of Technetium-99 showed black colored ischemic area Patients undergoing other procedures other than bypass such as valve repair Chronic kidney failure Patients have went through several bypass surgeries prior Patients are still COVID-19 positive Immunocompromised patients

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heart patch + cardiomyocytes - hAESC<br>Patients who undergo bypass (CABG) surgery are given heart patch in areas where grafting (bypass) is not feasible | Device: Heart patch seeded with autologous cardiomyocytes and amnion epithelial stem cells<br>* heart patch is seeded with patient's cardiomyocytes (taken from patient's heart waste tissue when undergoing bypass surgery) and stock amnion epithelial stem cells (HLA-DR negative to eliminate risk of rejection)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the ischemic burden (%) | Diagnosed by MRI | Comparison from the imaging within 3 months before intervention, and after 6 months post treatment. | 
| Change in the regional heart wall motion abnormality | measured using Echocardiographic | Observation of the heart wall motion by 1 week before intervention and 4 - 12 - 24 weeks after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the electrocardiographic wave | Measured using electrocardiogram | Observation of electrocardiogram records by 1 week before intervention and 4 - 12 - 24 weeks after intervention | 
| Change of the ejection fraction | Measured using echocardiography | Observation of the heart motion by 1 week before intervention and 4 - 12 - 24 weeks after intervention |