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

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)

Recruiting
Myocardial Infarction
Heart Diseases

Device: Heart patch seeded with autologous cardiomyocytes and amnion epithelial stem cells

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)

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 40 Years ~ Maximum: 60 Years
Countries
Indonesia
Locations

RSUPN dr. Cipto Mangunkusumo
Jakarta, DKI Jakarta, Indonesia

Rumah Sakit Universitas Indonesia
Depok, Jawa Barat, Indonesia

Pusat Jantung Nasional Harapan Kita
Jakarta, Indonesia

Contacts

Normalina Sandora, MD, PhD
+62 812-9896-3425
normalinasandora@gmail.com

Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
NCT Number
MeSH Terms
Myocardial Infarction
Heart Diseases
Infarction