Heart Patch for Myocardial Infarction COVID-19

Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

Status: Unknown

Conditions: Myocardial Infarction; Heart Diseases

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04728906

120/KEPK-RSB/X/20

Details and patient eligibility

About

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)

Enrollment: 10 estimated patients

Sex: All

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Heart patch + cardiomyocytes - hAESC

Experimental group

Description:

Patients who undergo bypass (CABG) surgery are given heart patch in areas where grafting (bypass) is not feasible

Treatment:

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