Heart Patch for Myocardial Infarction COVID-19

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04728906
• Other study ID #: 120/KEPK-RSB/X/20
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: February 2022
• Source: Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
• Contact: Normalina Sandora, MD, PhD
• Phone: +62 812-9896-3425
• Email: normalinasandora[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases
• Infarction
• Myocardial Infarction

Intervention

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)

Locations

Country	Name	City	State
Indonesia	Rumah Sakit Universitas Indonesia	Depok	Jawa Barat
Indonesia	Pusat Jantung Nasional Harapan Kita	Jakarta
Indonesia	RSUPN dr. Cipto Mangunkusumo	Jakarta	DKI Jakarta

Sponsors (5)

Lead Sponsor	Collaborator
Rumah Sakit Pusat Angkatan Darat Gatot Soebroto	Fakultas Kedokteran Universitas Indonesia, Pusat Jantung Nasional Harapan Kita, RSUPN dr. Cipto Mangunkusumo, Rumah Sakit Universitas Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the ischemic burden (%)	Diagnosed by MRI	Comparison from the imaging within 3 months before intervention, and after 6 months post treatment.
Primary	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	Change of the electrocardiographic wave	Measured using electrocardiogram	Observation of electrocardiogram records by 1 week before intervention and 4 - 12 - 24 weeks after intervention
Secondary	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