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Clinical Trials/NCT04728906
NCT04728906UnknownNot Applicable

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

Rumah Sakit Pusat Angkatan Darat Gatot Soebroto6 sites in 1 country10 target enrollmentStarted: April 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
10
Locations
6
Primary Endpoint
Change of the ischemic burden (%)

Study Overview

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)

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
40 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Normalina Sandora

Normalina Sandora, MD, MSc, PhD

Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

Study Sites (6)

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