Acute Myocardial InfarctionPhase 1/2AMINCT04340609
Stem Cell in Acute Myocardial Infarction
A Phase 1/2 study testing Mesenchymal Stem Cells in people with Acute Myocardial Infarction, run by PT. Prodia Stem Cell Indonesia at 1 site in Indonesia.
Trial summary
The study will perform UC-MSCs transplantation in 2 groups and 1 control group with standard treatment. Each group consists of 5 subjects. In the first group UC-MSCs will be transplanted via intravenous (IV) route and the second group via intracoronary (IC) route. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Mesenchymal Stem Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteIndonesia
- Study dates
- 11 Mar 2019to 8 Apr 2022
- Phase
- Phase 1/2
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- STEMI patients within 5 days after symptom onset of a first ST-segment elevation myocardial infarction
- Have undergone successful percutaneous coronary intervention (PCI) with drug eluting stent implantation of the infarct-related artery and demonstrated hypokinesia or akinesia that involved more than two thirds of the LV anteroseptal, lateral, or inferior wall with LV ejection fraction of < 45% by echocardiography.
- Ability to understand and provide signed informed consent, or have a designated legal guardian or spouse legally able and willing to make such decisions on the subject's behalf,
- Willingness to attend all scheduled safety follow-up visits
- Subjects need to have a specific criteria of having a single vessel disease (ostial or proximal LAD vessels) that caused extensive anterior infarction (EF <45).
Who cannot join
- Hemodynamic instability as demonstrated by any of the following,
- Requirement of intra-aortic balloon pump of left ventricular assist device,
- Need for inotropic support (e.g. dopamine and/or dobutamine) for more than 36 hours for the maintenance of mean arterial blood pressure ≥ 60 mmHg,
- Previous or current concomitant serious illnesses, such as cancer, hematological disorders (Hb < 10 g/dL, WBC < 4 or > 11x109/L, or platelets < 100x109/L), kidney failure (creatinine level > 2.5 mg/dL, or creatinine clearance < 30 cc/min), serious infection or any other co-morbidities that could impact patient's short-term survival, psychiatric illness, history of drug of alcohol abuse,
- Prosthetic valves,
- Hypertrophic or restrictive cardiomyopathy,
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- Women of child-bearing potential,
- Inability to comply with the protocol,
- Currently using implantable electronic defibrillator or pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy for Acute Myocardial Infarction
The study will perform UC-MSCs transplantation in 2 groups and 1 control group with standard treatment. Each group consists of 5 subjects. In the first group UC-MSCs will be transplanted via intravenous (IV) route and the second group via intracoronary (IC) route. The IV group will receive 2 million cells/kg for each subject and the dosage of IC group is 50 million cells for each subject. All groups will be observed until 1 year.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Mesenchymal Stem Cells
- Keywords
- Allogeneic Mesenchymal Stem Cells, Umbilical Cord Mesenchymal Stem Cells, Intravenous Mesenchymal Stem Cells, Intracoronary Mesenechymal Stem Cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stem CellsBiological
The UC-MSCs from a donor will be cultured in a clinical grade laboratory with xeno-free medium. Maximum passage of expanded-UC MSCs was VI and doubling population is less than 30. To assure the quality of our expanded-UC MSCs at ProSTEM the following tests are done: cell adherence, cell surface marker, in vitro differentiation, cell viability, sterility, Mycoplasma, endotoxin, and karyotyping.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Group | Experimental | Dosage of intravenous route is 2 million MSCs/kg for each subject. Receives: Biological: Mesenchymal Stem Cells |
| Intracoronary Group | Experimental | Dosage of intracoronary route is ±50 million MSCs for each subject. Receives: Biological: Mesenchymal Stem Cells |
| Control Group | No intervention | Standard treatment of acute myocardia infarction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events (MACE) endpoints of mortality
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Measured: 2 weeks after stem cell
Major adverse cardiac events (MACE) endpoints of mortality
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Measured: 3 months after stem cell
Major adverse cardiac events (MACE) endpoints of mortality
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Measured: 6 months after stem cell
Major adverse cardiac events (MACE) endpoints of mortality
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Measured: 12 months after stem cell
Re-infarction
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Measured: 2 weeks after stem cell
Re-infarction
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Measured: 3 months after stem cell
Re-infarction
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Measured: 6 months after stem cell
Re-infarction
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Measured: 12 months after stem cell
Target vessel revascularization (TVR)
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Measured: 2 weeks after stem cell
Target vessel revascularization (TVR)
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Measured: 3 months after stem cell
Target vessel revascularization (TVR)
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Measured: 6 months after stem cell
Target vessel revascularization (TVR)
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Measured: 12 months after stem cell
Heart failure hospitalization
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Measured: 2 weeks after stem cell
Heart failure hospitalization
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Measured: 3 months after stem cell
Heart failure hospitalization
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Measured: 6 months after stem cell
Heart failure hospitalization
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Measured: 12 months after stem cell
Secondary outcomes (9)
Cardiac MRI
a test to see improvement in LVEF(%), improvement in regional function, improvement in perfusion, reduction of infarct size.
Measured: 6 months after stem cell
Cardiac MRI
a test to see improvement in LVEF (%), improvement in regional function, improvement in perfusion, reduction of infarct size.
Measured: 12 months after stem cell
Echocardiography
Left ventricular volumes will be determined at end-diastole and end-systole by quantitative biplane assessment. Endocardial borders will be manually traced from apical four-chamber and two-chamber views. Left ventricular volumes will be used to calculate ejection fraction using the biplane modified Simpson's summation-of-disks method recommended by the American Society of Echocardiography.
Measured: 6 months after stem cell
Echocardiography
Left ventricular volumes will be determined at end-diastole and end-systole by quantitative biplane assessment. Endocardial borders will be manually traced from apical four-chamber and two-chamber views. Left ventricular volumes will be used to calculate ejection fraction using the biplane modified Simpson's summation-of-disks method recommended by the American Society of Echocardiography.
Measured: 12 months after stem cell
Electrocardiography (ECG)
to detects cardiac (heart) abnormalities by measuring the electrical activity generated by the heart as it contracts
Measured: 3 months after stem cell
Electrocardiography (ECG)
to detects cardiac (heart) abnormalities by measuring the electrical activity generated by the heart as it contracts
Measured: 6 months after stem cell
Electrocardiography (ECG)
to detects cardiac (heart) abnormalities by measuring the electrical activity generated by the heart as it contracts
Measured: 12 months after stem cell
Wellness Parameter
hs-CRP, antioxidant, IL-6, IL-10, PA1, Fibrinogen
Measured: 6 months after stem cell
Laboratory Assessment
Haematology, Serum Chemistry, Cardiac Biomarker
Measured: 12 months after stem cell
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start11 Mar 2019
- Primary completion8 Apr 2021
- Study completion8 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT. Prodia Stem Cell Indonesia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340609
- Sponsor's protocol ID
- CT/AMI/01/2019
- Acronym
- AMI
- Status last verified
- Jun 2022
- First submitted
- 8 Feb 2020
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy for Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT04340609
- Acronym / sponsor ID
- AMI / CT/AMI/01/2019
- Conditions
- Acute Myocardial Infarction
- Keywords
- Allogeneic Mesenchymal Stem Cells, Umbilical Cord Mesenchymal Stem Cells, Intravenous Mesenchymal Stem Cells, Intracoronary Mesenechymal Stem Cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- PT. Prodia Stem Cell IndonesiaIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 8 Apr 2021 (actual)
- Study completion
- 8 Apr 2022 (actual)
- First posted
- 9 Apr 2020 (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.
The study will perform UC-MSCs transplantation in 2 groups and 1 control group with standard treatment. Each group consists of 5 subjects. In the first group UC-MSCs will be transplanted via intravenous (IV) route and the second group via intracoronary (IC) route. The IV group will receive 2 million cells/kg for each subject and the dosage of IC group is 50 million cells for each subject. All groups will be observed until 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intravenous Group | Experimental | Biological: Mesenchymal Stem CellsDosage of intravenous route is 2 million MSCs/kg for each subject. |
| Intracoronary Group | Experimental | Biological: Mesenchymal Stem CellsDosage of intracoronary route is ±50 million MSCs for each subject. |
| Control Group | No intervention | –Standard treatment of acute myocardia infarction |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- STEMI patients within 5 days after symptom onset of a first ST-segment elevation myocardial infarction
- Have undergone successful percutaneous coronary intervention (PCI) with drug eluting stent implantation of the infarct-related artery and demonstrated hypokinesia or akinesia that involved more than two thirds of the LV anteroseptal, lateral, or inferior wall with LV ejection fraction of < 45% by echocardiography.
- Ability to understand and provide signed informed consent, or have a designated legal guardian or spouse legally able and willing to make such decisions on the subject's behalf,
- Willingness to attend all scheduled safety follow-up visits
- Subjects need to have a specific criteria of having a single vessel disease (ostial or proximal LAD vessels) that caused extensive anterior infarction (EF <45).
Key exclusion criteria (9 listed)
- Hemodynamic instability as demonstrated by any of the following,
- Requirement of intra-aortic balloon pump of left ventricular assist device,
- Need for inotropic support (e.g. dopamine and/or dobutamine) for more than 36 hours for the maintenance of mean arterial blood pressure ≥ 60 mmHg,
- Previous or current concomitant serious illnesses, such as cancer, hematological disorders (Hb < 10 g/dL, WBC < 4 or > 11x109/L, or platelets < 100x109/L), kidney failure (creatinine level > 2.5 mg/dL, or creatinine clearance < 30 cc/min), serious infection or any other co-morbidities that could impact patient's short-term survival, psychiatric illness, history of drug of alcohol abuse,
- Prosthetic valves,
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 |
|---|---|---|
| Mesenchymal Stem CellsThe UC-MSCs from a donor will be cultured in a clinical grade laboratory with xeno-free medium. Maximum passage of expanded-UC MSCs was VI and doubling population is less than 30. To assure the quality of our expanded-UC MSCs at ProSTEM the following tests are done: cell adherence, cell surface marker, in vitro differentiation, cell viability, sterility, Mycoplasma, endotoxin, and karyotyping. | Biological | Intracoronary Group, Intravenous Group |
Primary outcome
Major adverse cardiac events (MACE) endpoints of mortality
Time frame: 2 weeks after stem cell
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Major adverse cardiac events (MACE) endpoints of mortality
Time frame: 3 months after stem cell
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Major adverse cardiac events (MACE) endpoints of mortality
Time frame: 6 months after stem cell
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Major adverse cardiac events (MACE) endpoints of mortality
Time frame: 12 months after stem cell
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Re-infarction
Time frame: 2 weeks after stem cell
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Re-infarction
Time frame: 3 months after stem cell
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Re-infarction
Time frame: 6 months after stem cell
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Re-infarction
Time frame: 12 months after stem cell
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Target vessel revascularization (TVR)
Time frame: 2 weeks after stem cell
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Target vessel revascularization (TVR)
Time frame: 3 months after stem cell
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Target vessel revascularization (TVR)
Time frame: 6 months after stem cell
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Target vessel revascularization (TVR)
Time frame: 12 months after stem cell
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Heart failure hospitalization
Time frame: 2 weeks after stem cell
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Heart failure hospitalization
Time frame: 3 months after stem cell
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Heart failure hospitalization
Time frame: 6 months after stem cell
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
Heart failure hospitalization
Time frame: 12 months after stem cell
To assess the safety of using allogeneic UC-MSCs therapy for acute myocardial infarction.
9 secondary outcomes
Cardiac MRI
Time frame: 6 months after stem cell
Cardiac MRI
Time frame: 12 months after stem cell
Echocardiography
Time frame: 6 months after stem cell
Echocardiography
Time frame: 12 months after stem cell
Electrocardiography (ECG)
Time frame: 3 months after stem cell
Electrocardiography (ECG)
Time frame: 6 months after stem cell
Electrocardiography (ECG)
Time frame: 12 months after stem cell
Wellness Parameter
Time frame: 6 months after stem cell
Laboratory Assessment
Time frame: 12 months after stem cell
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mesenchymal Stem Cells in people with Acute Myocardial Infarction, run by PT. Prodia Stem Cell Indonesia at 1 site 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 9 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: finished, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac events (MACE) endpoints of mortality (time frame: 2 weeks after stem cell). The study lists 16 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 14 Jun 2022.