Targeted-cell Therapy Using Epithelial Stem Cells and Patients' Cardiomyocytes Loaded in Amnion Bilayer to Regenerate Myocardial Infarction Post COVID-19 Complication
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
Normalina Sandora
Normalina Sandora, MD, MSc, PhD
Rumah Sakit Pusat Angkatan Darat Gatot Soebroto