Heart Patch for Myocardial Infarction COVID-19

February 14, 2022 updated by: Normalina Sandora, Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

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

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Indonesia
      • Jakarta, Indonesia, 11420
        • Not yet recruiting
        • Pusat Jantung Nasional Harapan Kita
        • Contact:
          • Tri W Soetisna, MD
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 10430
    • Jawa Barat
      • Depok, Jawa Barat, Indonesia, 16424
        • Not yet recruiting
        • Rumah Sakit Universitas Indonesia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the ischemic burden (%)
Time Frame: Comparison from the imaging within 3 months before intervention, and after 6 months post treatment.
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
Time Frame: Observation of the heart wall motion by 1 week before intervention and 4 - 12 - 24 weeks after intervention
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
Time Frame: Observation of electrocardiogram records by 1 week before intervention and 4 - 12 - 24 weeks after intervention
Measured using electrocardiogram
Observation of electrocardiogram records by 1 week before intervention and 4 - 12 - 24 weeks after intervention
Change of the ejection fraction
Time Frame: Observation of the heart motion by 1 week before intervention and 4 - 12 - 24 weeks after intervention
Measured using echocardiography
Observation of the heart motion by 1 week before intervention and 4 - 12 - 24 weeks after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2022

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

January 26, 2021

First Submitted That Met QC Criteria

January 27, 2021

First Posted (Actual)

January 28, 2021

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 14, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 120/KEPK-RSB/X/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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