NCT04728906

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 28, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

5 months

First QC Date

January 26, 2021

Last Update Submit

February 14, 2022

Conditions

Myocardial InfarctionHeart Diseases

Outcome Measures

Primary Outcomes (2)

  • Change of the ischemic burden (%)

    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

    measured using Echocardiographic

    Observation of the heart wall motion by 1 week before intervention and 4 - 12 - 24 weeks after intervention

Secondary Outcomes (2)

  • Change of the electrocardiographic wave

    Observation of electrocardiogram records by 1 week before intervention and 4 - 12 - 24 weeks after intervention

  • Change of the ejection fraction

    Observation of the heart motion by 1 week before intervention and 4 - 12 - 24 weeks after intervention

Study Arms (1)

Heart patch + cardiomyocytes - hAESC

EXPERIMENTAL

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

Interventions

Heart patch seeded with autologous cardiomyocytes and amnion epithelial stem cellsDEVICE

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)

Heart patch + cardiomyocytes - hAESC

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

RSUPN dr. Cipto Mangunkusumo

Jakarta, DKI Jakarta, 10430, Indonesia

RECRUITING

Rumah Sakit Universitas Indonesia

Depok, West Java, 16424, Indonesia

NOT YET RECRUITING

Pusat Jantung Nasional Harapan Kita

Jakarta, 11420, Indonesia

NOT YET RECRUITING

MeSH Terms

Conditions

Myocardial InfarctionHeart Diseases

Condition Hierarchy (Ancestors)

Myocardial IschemiaCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Normalina Sandora, MD, PhD

CONTACT

+62 812-9896-3425normalinasandora@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Normalina Sandora, MD, MSc, PhD

Study Record Dates

First Submitted

January 26, 2021

First Posted

January 28, 2021

Study Start

April 1, 2022

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

March 2, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

ID(3)