Myocardial InfarctionNCT04728906
Heart Patch for Myocardial Infarction COVID-19
A study testing Heart patch seeded with autologous cardiomyocytes and amnion epithelial stem cells in people with Myocardial Infarction and Heart Diseases, run by Rumah Sakit Pusat Angkatan Darat Gatot Soebroto at 3 sites in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Myocardial Infarction, Heart Diseases
- What is being tested?
- Heart patch seeded with autologous cardiomyocytes and amnion epithelial stem cells
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesIndonesia
- Study dates
- 1 Apr 2022to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Indonesia3 sites, 3 recruiting
- Not yet recruiting
Rumah Sakit Universitas Indonesia
Depok, West Java, 16424
Muhammad A Putra, MD, arzaputra@gmail.com
- Recruiting
RSUPN dr. Cipto Mangunkusumo
Jakarta, DKI Jakarta, 10430
Normalina Sandora, PhD, normalinasandora@gmail.com
- Not yet recruiting
Pusat Jantung Nasional Harapan Kita
Jakarta, 11420
Tri W Soetisna, MD
About this study
Official title: Targeted-cell Therapy Using Epithelial Stem Cells and Patients' Cardiomyocytes Loaded in Amnion Bilayer to Regenerate Myocardial Infarction Post COVID-19 Complication
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)
- Conditions
- Myocardial Infarction, Heart Diseases
- Being tested
- Heart patch seeded with autologous cardiomyocytes and amnion epithelial stem cells
- Medical subject headings
- Myocardial Infarction, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Heart patch + cardiomyocytes - hAESC | Experimental | Patients who undergo bypass (CABG) surgery are given heart patch in areas where grafting (bypass) is not feasible Receives: Device: Heart patch seeded with autologous cardiomyocytes and amnion epithelial stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the ischemic burden (%)
Diagnosed by MRI
Measured: 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
Measured: 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
Measured using electrocardiogram
Measured: Observation of electrocardiogram records by 1 week before intervention and 4 - 12 - 24 weeks after intervention
Change of the ejection fraction
Measured using echocardiography
Measured: Observation of the heart motion by 1 week before intervention and 4 - 12 - 24 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start1 Apr 2022 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
- Sponsor type
- University, hospital or other
- Collaborators
- Fakultas Kedokteran Universitas Indonesia, RSUPN dr. Cipto Mangunkusumo, Rumah Sakit Universitas Indonesia, Pusat Jantung Nasional Harapan Kita
- Responsible party
- Principal investigator, Normalina Sandora, Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728906
- Sponsor's protocol ID
- 120/KEPK-RSB/X/20
- Status last verified
- Feb 2022
- First submitted
- 26 Jan 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted-cell Therapy Using Epithelial Stem Cells and Patients' Cardiomyocytes Loaded in Amnion Bilayer to Regenerate Myocardial Infarction Post COVID-19 Complication
- ClinicalTrials.gov ID
- NCT04728906
- Acronym / sponsor ID
- 120/KEPK-RSB/X/20
- Conditions
- Myocardial Infarction, Heart Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Rumah Sakit Pusat Angkatan Darat Gatot SoebrotoUniversity, hospital or other
- Collaborators
- Fakultas Kedokteran Universitas Indonesia, RSUPN dr. Cipto Mangunkusumo, Rumah Sakit Universitas Indonesia, Pusat Jantung Nasional Harapan Kita
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 28 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart patch + cardiomyocytes - hAESC | Experimental | Device: Heart patch seeded with autologous cardiomyocytes and amnion epithelial stem cellsPatients who undergo bypass (CABG) surgery are given heart patch in areas where grafting (bypass) is not feasible |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart patch seeded with autologous cardiomyocytes and amnion epithelial stem cellsheart 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) | Device | Heart patch + cardiomyocytes - hAESC |
Primary outcome
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
2 secondary outcomes
Change of the electrocardiographic wave
Time frame: Observation of electrocardiogram records by 1 week before intervention and 4 - 12 - 24 weeks after intervention
Change of the ejection fraction
Time frame: Observation of the heart motion by 1 week before intervention and 4 - 12 - 24 weeks after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Myocardial Infarction
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
SuperSaturated Oxygen Comprehensive Observational Registry
STEMI - ST Elevation Myocardial Infarction, AMI
Not yet recruitingPhase 4
Capital Offload-Shock
Hypervolemia, Cardiogenic Shock
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart patch seeded with autologous cardiomyocytes and amnion epithelial stem cells in people with Myocardial Infarction and Heart Diseases, run by Rumah Sakit Pusat Angkatan Darat Gatot Soebroto at 3 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Normalina Sandora, MD, PhD (+62 812-9896-3425, normalinasandora@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the ischemic burden (%) (time frame: Comparison from the imaging within 3 months before intervention, and after 6 months post treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.