Acute Myocardial InfarctionPhase 3MAGICcell6NCT06364150
Therapeutic Use of Angiopoietin-Primed Autologous Peripheral Blood Stem Cell in Myocardial Infarction
A Phase 3 study testing Autologous Peripheral Blood Stem Cell injection in people with Acute Myocardial Infarction, run by Seoul National Hospital at 1 site in South Korea.
Trial summary
This study will evaluate the efficacy and safety of "Therapeutic Use of Autologous-Primed Autologous Peripheral Blood Stem Cell Treatment for Myocardial Regeneration in Acute Myocardial Infarction". Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Autologous Peripheral Blood Stem Cell injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Jul 2024to 1 Aug 2026
- Phase
- Phase 3
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Male and female aged ≥19 years and ≤ 80 years
- 2. A clinical diagnosis of acute myocardial infarction within 4 weeks from randomization
- 3. Successful percutaneous coronary intervention to the target lesion (TIMI flow grade 3 and residual stenosis <30% at the target lesion) with a drug-eluting stent and/or drug-eluting balloon
- 4. Agreement to give written informed consent.
Who cannot join
- Patients with uncontrolled heart failure (Killip class ≥ grade 2, or left ventricular ejection fraction <20%)
- Patients with uncontrolled chest pain due to ischemia
- Patients with uncontrolled arrythmia
- Active malignancy, or incompletely treated malignancy
- Active infectious disease
- Uncontrolled hematologic disease, including coagulopathy or bleeding diathesis
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- Presence of non-cardiac comorbidity with life expectancy ≤1 year from randomization
- Females with childbearing potential or breast-feeding
- Refusal to give written informed consent
- Other conditions that may result in protocol non-compliance by the committees
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Jeehoon Kang, MD, PhD, +82-2-2072-1181, medikang@gmail.com
Hyun-Jai Cho, MD, PhD
About this study
This study will evaluate the efficacy and safety of "Therapeutic Use of Autologous-Primed Autologous Peripheral Blood Stem Cell Treatment for Myocardial Regeneration in Acute Myocardial Infarction".
Read the detailed description
Patients diagnosed with acute myocardial infarction will receive percutaneous coronary intervention to the culprit coronary artery according to standard procedures. For peripheral blood stem cell mobilization, Granulocyte colony-stimulating factor (G-CSF) and erythropoietin (EPO) will be injected for a total of 4 days, followed by collection of mobilized peripheral blood stem cell (mobPBSC) via apheresis. In ex-vivo setting, mobPBSC will be primed with angiopoietin 1 (Ang1) for 1 hour. A total of 2 X109 Ang1 primed mobPBSC will be injected to the culprit artery.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Autologous Peripheral Blood Stem Cell injection
- Keywords
- Peripheral Blood Stem Cell Treatment, Acute Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Peripheral Blood Stem Cell injectionBiological
For peripheral blood stem cell mobilization, G-CSF and EPO will be injected for a total of 4 days, followed by collection of mobPBSC via apheresis. In ex-vivo setting, mobPBSC will be primed with Ang1 for 1 hour. A total of 2 X109 Ang1 primed mobPBSC will be injected to the culprit artery.
| Study group | Role | What they receive |
|---|---|---|
| Cell treatment arm | Experimental | Patients who receive Angiopoietin-Primed Autologous Peripheral Blood Stem Cell in Myocardial Infarction Receives: Biological: Autologous Peripheral Blood Stem Cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular systolic function
Left ventricular ejection fraction measured by echocardiography (measured in percent)
Measured: 12 months after treatment
Secondary outcomes (8)
Regional wall motion score index
Regional wall motion score index measured by echocardiography. The score is scaled from 1.0 to 4.0. Using a standard transthoracic echocardiography sequence, each one of the 16 myocardial segments are assigned a score from 1 to 4. The scores for 16 segments are scaled as normokinesia (1 point) or hypokinesia (2 points) or akinesia (3 points) or dyskinesia (4 points). A score of 1.0 is considered normokinetic, and a score of 3.0 correlated as akinetic.
Measured: 12 months after treatment
B-natriuretic peptide level
Laboratory test which is measured in picograms per milliliter (pg/ml).
Measured: 12 months after treatment
6-minute walk test
6-minute walk test is measured in meters.
Measured: 12 months after treatment
All-cause death
Rate of patients with a mortality event due to any cause
Measured: 12 months after treatment
Target lesion Revascularization
Rate of patients who received additional revascularization for the target lesion (the coronary lesion that was treated at the index procedure)
Measured: 12 months after treatment
Readmssion
Rate of patients who were readmitted due to any cause
Measured: 12 months after treatment
Cardiovascular death
Rate of patients with a mortality event due to cardiovascular cause
Measured: 12 months after treatment
non-Target lesion Revascularization
Rate of patients who received additional revascularization for a non-target lesion (the coronary lesion that was NOT treated at the index procedure)
Measured: 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start15 Jul 2024
- Primary completion1 May 2025 (estimated)
- Study completion1 Aug 2026 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single arm, open label interventional study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National Hospital
- Sponsor type
- Other government
- Collaborators
- Seoul National University Hospital
- Responsible party
- Principal investigator, Hyun-Jai Cho, Seoul National University Hospital
- Investigators
- Hyun Jai Cho, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364150
- Sponsor's protocol ID
- MAGIC6
- Acronym
- MAGICcell6
- Status last verified
- Apr 2024
- First submitted
- 28 Mar 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Any request for data sharing should be sent as an inquiry to the principle investigator.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Use of Angiopoietin-Primed Autologous Peripheral Blood Stem Cell in Myocardial Infarction
- ClinicalTrials.gov ID
- NCT06364150
- Acronym / sponsor ID
- MAGICcell6 / MAGIC6
- Conditions
- Acute Myocardial Infarction
- Keywords
- Peripheral Blood Stem Cell Treatment, Acute Myocardial Infarction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Seoul National HospitalOther government
- Collaborators
- Seoul National University Hospital
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 15 Apr 2024 (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.
This study will evaluate the efficacy and safety of "Therapeutic Use of Autologous-Primed Autologous Peripheral Blood Stem Cell Treatment for Myocardial Regeneration in Acute Myocardial Infarction".
Detailed description
Patients diagnosed with acute myocardial infarction will receive percutaneous coronary intervention to the culprit coronary artery according to standard procedures. For peripheral blood stem cell mobilization, Granulocyte colony-stimulating factor (G-CSF) and erythropoietin (EPO) will be injected for a total of 4 days, followed by collection of mobilized peripheral blood stem cell (mobPBSC) via apheresis. In ex-vivo setting, mobPBSC will be primed with angiopoietin 1 (Ang1) for 1 hour. A total of 2 X109 Ang1 primed mobPBSC will be injected to the culprit artery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single arm, open label interventional study
| Arm | Type | Receives |
|---|---|---|
| Cell treatment arm | Experimental | Biological: Autologous Peripheral Blood Stem Cell injectionPatients who receive Angiopoietin-Primed Autologous Peripheral Blood Stem Cell in Myocardial Infarction |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Male and female aged ≥19 years and ≤ 80 years
- 2. A clinical diagnosis of acute myocardial infarction within 4 weeks from randomization
- 3. Successful percutaneous coronary intervention to the target lesion (TIMI flow grade 3 and residual stenosis <30% at the target lesion) with a drug-eluting stent and/or drug-eluting balloon
- 4. Agreement to give written informed consent.
Key exclusion criteria (10 listed)
- Patients with uncontrolled heart failure (Killip class ≥ grade 2, or left ventricular ejection fraction <20%)
- Patients with uncontrolled chest pain due to ischemia
- Patients with uncontrolled arrythmia
- Active malignancy, or incompletely treated malignancy
- Active infectious disease
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 |
|---|---|---|
| Autologous Peripheral Blood Stem Cell injectionFor peripheral blood stem cell mobilization, G-CSF and EPO will be injected for a total of 4 days, followed by collection of mobPBSC via apheresis. In ex-vivo setting, mobPBSC will be primed with Ang1 for 1 hour. A total of 2 X109 Ang1 primed mobPBSC will be injected to the culprit artery. | Biological | Cell treatment arm |
Primary outcome
Left ventricular systolic function
Time frame: 12 months after treatment
Left ventricular ejection fraction measured by echocardiography (measured in percent)
8 secondary outcomes
Regional wall motion score index
Time frame: 12 months after treatment
B-natriuretic peptide level
Time frame: 12 months after treatment
6-minute walk test
Time frame: 12 months after treatment
All-cause death
Time frame: 12 months after treatment
Target lesion Revascularization
Time frame: 12 months after treatment
Readmssion
Time frame: 12 months after treatment
Cardiovascular death
Time frame: 12 months after treatment
non-Target lesion Revascularization
Time frame: 12 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Individual participant dataSharing planned: No. Any request for data sharing should be sent as an inquiry to the principle investigator.
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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.
Hyun Jai Cho, MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Autologous Peripheral Blood Stem Cell injection in people with Acute Myocardial Infarction, run by Seoul National Hospital at 1 site in South Korea.
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 4 inclusion and 10 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 3 Dec 2024. 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 South Korea. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jeehoon Kang, MD (+821024162406, medikang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular systolic function (time frame: 12 months after treatment). 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 3 Dec 2024.