Heart Patch for Myocardial Infarction COVID-19

Sponsor

Rumah Sakit Pusat Angkatan Darat Gatot Soebroto (Other)

Overall Status

Recruiting

CT.gov ID

NCT04728906

Collaborator

Fakultas Kedokteran Universitas Indonesia (Other), RSUPN dr. Cipto Mangunkusumo (Other), Rumah Sakit Universitas Indonesia (Other), Pusat Jantung Nasional Harapan Kita (Other)

Enrollment

Locations

Arm

Anticipated Duration (Months)

3.3

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction Heart Diseases	Device: Heart patch seeded with autologous cardiomyocytes and amnion epithelial stem cells	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Heart patch + cardiomyocytes - hAESC 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 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)

Arm

Intervention/Treatment

Experimental: Heart patch + cardiomyocytes - hAESC

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

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)

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Change of the electrocardiographic wave [Observation of electrocardiogram records by 1 week before intervention and 4 - 12 - 24 weeks after intervention]
Measured using electrocardiogram
Change of the ejection fraction [Observation of the heart motion by 1 week before intervention and 4 - 12 - 24 weeks after intervention]
Measured using echocardiography

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	RSUPN dr. Cipto Mangunkusumo	Jakarta	DKI Jakarta	Indonesia	10430
2	Rumah Sakit Universitas Indonesia	Depok	Jawa Barat	Indonesia	16424
3	Pusat Jantung Nasional Harapan Kita	Jakarta		Indonesia	11420

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Normalina Sandora, Normalina Sandora, MD, MSc, PhD, Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

ClinicalTrials.gov Identifier:

NCT04728906

Other Study ID Numbers:

120/KEPK-RSB/X/20

First Posted:

Jan 28, 2021

Last Update Posted:

Mar 2, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Myocardial Infarction

Heart Diseases

Infarction

Study Results

No Results Posted as of Mar 2, 2022