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Heart Patch for Myocardial Infarction COVID-19

Primary Purpose

Myocardial Infarction, Heart Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Heart patch seeded with autologous cardiomyocytes and amnion epithelial stem cells
Sponsored by
Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • RSUPN dr. Cipto MangunkusumoRecruiting
  • Rumah Sakit Universitas Indonesia
  • Pusat Jantung Nasional Harapan Kita

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Heart patch + cardiomyocytes - hAESC

Arm Description

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

Outcomes

Primary Outcome Measures

Change of the ischemic burden (%)
Diagnosed by MRI
Change in the regional heart wall motion abnormality
measured using Echocardiographic

Secondary Outcome Measures

Change of the electrocardiographic wave
Measured using electrocardiogram
Change of the ejection fraction
Measured using echocardiography

Full Information

First Posted
January 26, 2021
Last Updated
February 14, 2022
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
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1. Study Identification

Unique Protocol Identification Number
NCT04728906
Brief Title
Heart Patch for Myocardial Infarction COVID-19
Official Title
Targeted-cell Therapy Using Epithelial Stem Cells and Patients' Cardiomyocytes Loaded in Amnion Bilayer to Regenerate Myocardial Infarction Post COVID-19 Complication
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Anticipated)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Heart Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Heart patch + cardiomyocytes - hAESC
Arm Type
Experimental
Arm Description
Patients who undergo bypass (CABG) surgery are given heart patch in areas where grafting (bypass) is not feasible
Intervention Type
Device
Intervention Name(s)
Heart patch seeded with autologous cardiomyocytes and amnion epithelial stem cells
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change of the ischemic burden (%)
Description
Diagnosed by MRI
Time Frame
Comparison from the imaging within 3 months before intervention, and after 6 months post treatment.
Title
Change in the regional heart wall motion abnormality
Description
measured using Echocardiographic
Time Frame
Observation of the heart wall motion by 1 week before intervention and 4 - 12 - 24 weeks after intervention
Secondary Outcome Measure Information:
Title
Change of the electrocardiographic wave
Description
Measured using electrocardiogram
Time Frame
Observation of electrocardiogram records by 1 week before intervention and 4 - 12 - 24 weeks after intervention
Title
Change of the ejection fraction
Description
Measured using echocardiography
Time Frame
Observation of the heart motion by 1 week before intervention and 4 - 12 - 24 weeks after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Normalina Sandora, MD, PhD
Phone
+62 812-9896-3425
Email
normalinasandora@gmail.com
Facility Information:
Facility Name
RSUPN dr. Cipto Mangunkusumo
City
Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Normalina Sandora, PhD
Email
normalinasandora@gmail.com
Facility Name
Rumah Sakit Universitas Indonesia
City
Depok
State/Province
Jawa Barat
ZIP/Postal Code
16424
Country
Indonesia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad A Putra, MD
Email
arzaputra@gmail.com
Facility Name
Pusat Jantung Nasional Harapan Kita
City
Jakarta
ZIP/Postal Code
11420
Country
Indonesia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tri W Soetisna, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Heart Patch for Myocardial Infarction COVID-19

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