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Heart Patch for Myocardial Infarction COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04728906
Recruitment Status : Recruiting
First Posted : January 28, 2021
Last Update Posted : March 2, 2022
Sponsor:
Collaborators:
Fakultas Kedokteran Universitas Indonesia
RSUPN dr. Cipto Mangunkusumo
Rumah Sakit Universitas Indonesia
Pusat Jantung Nasional Harapan Kita
Information provided by (Responsible Party):
Normalina Sandora, Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

Study Description
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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)

Condition or disease Intervention/treatment Phase
Myocardial Infarction Heart Diseases Device: Heart patch seeded with autologous cardiomyocytes and amnion epithelial stem cells Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Targeted-cell Therapy Using Epithelial Stem Cells and Patients' Cardiomyocytes Loaded in Amnion Bilayer to Regenerate Myocardial Infarction Post COVID-19 Complication
Estimated Study Start Date : April 1, 2022
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Heart patch + cardiomyocytes - hAESC
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
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)


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. Change of the electrocardiographic wave [ Time Frame: Observation of electrocardiogram records by 1 week before intervention and 4 - 12 - 24 weeks after intervention ]
    Measured using electrocardiogram

  2. Change of the ejection fraction [ Time Frame: Observation of the heart motion by 1 week before intervention and 4 - 12 - 24 weeks after intervention ]
    Measured using echocardiography


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04728906


Contacts
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Contact: Normalina Sandora, MD, PhD +62 812-9896-3425 normalinasandora@gmail.com

Locations
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Indonesia
RSUPN dr. Cipto Mangunkusumo Recruiting
Jakarta, DKI Jakarta, Indonesia, 10430
Contact: Normalina Sandora, PhD       normalinasandora@gmail.com   
Rumah Sakit Universitas Indonesia Not yet recruiting
Depok, Jawa Barat, Indonesia, 16424
Contact: Muhammad A Putra, MD       arzaputra@gmail.com   
Pusat Jantung Nasional Harapan Kita Not yet recruiting
Jakarta, Indonesia, 11420
Contact: Tri W Soetisna, MD         
Sponsors and Collaborators
Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
Fakultas Kedokteran Universitas Indonesia
RSUPN dr. Cipto Mangunkusumo
Rumah Sakit Universitas Indonesia
Pusat Jantung Nasional Harapan Kita
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Normalina Sandora, Normalina Sandora, MD, MSc, PhD, Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
ClinicalTrials.gov Identifier: NCT04728906    
Other Study ID Numbers: 120/KEPK-RSB/X/20
First Posted: January 28, 2021    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
Heart Diseases
Infarction
Ischemia
Pathologic Processes
 Necrosis
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases