Targeted-cell Therapy Using Epithelial Stem Cells and Patients' Cardiomyocytes Loaded in Amnion Bilayer to Regenerate Myocardial Infarction Post COVID-19 Complication
Sponsor study identifier
interventional
10
1 country
3
Study Start
April 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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)
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 26, 2021
Actual (reported)January 28, 2021
Actual (reported)April 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
Patients who undergo bypass (CABG) surgery are given heart patch in areas where grafting (bypass) is not feasible
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)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
RSUPN dr. Cipto Mangunkusumo
Jakarta, DKI Jakarta, 10430, Indonesia
Rumah Sakit Universitas Indonesia
Depok, West Java, 16424, Indonesia
First Submitted
January 26, 2021
First Posted
January 28, 2021
Study Start
April 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 1, 2022
Cognitive Behavioral Therapy Following Myocardial Infarction
Contact the study team to confirm eligibility.
Pusat Jantung Nasional Harapan Kita
Jakarta, 11420, Indonesia
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 2, 2022
Record last verified: 2022-02
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Source: ClinicalTrials.gov.
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