Myocardial InfarctionPhase 1/2AMI-DCNCT05554484
AMI-DC in Patients With Anterior Wall Myocardial Infarction
A Phase 1/2 study testing Autologous peripheral blood-derived tolerogenic dendritic cells in people with Myocardial Infarction, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
The purpose of this trial is to assess the safety of AMI-DC treatment. The participants who voluntarily sign the consent form will be screened according to the inclusion/exclusion criteria then allocated either to the experimental group (drug therapy and AMI-DC therapy) or to the control group (drug therapy only). Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Autologous peripheral blood-derived tolerogenic dendritic cells
- 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
- 7 Jun 2021to 30 Oct 2023
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteers who qualify all the following conditions
- Between the ages 19 through 80
- Patients within 24 hours from primary PCI with a diagnosis of acute anterior wall ST-segment elevation myocardial infarction and systolic dysfunction:
- acute myocardial infarction patient with an electrocardiogram (12-lead ECG) result corresponding to any of the following (ST-segment elevation 0.1 mV in two or more limb leads or 0.2 mV elevation in two or more contiguous precordial leads)
- Left ventricular ejection fraction (LVEF) below 50% by echocardiography
- Hemodynamically stable (SBP >100 mmHg, HR <110 bpm, SO2 >95%)
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- Able-bodied for collection of approximately 300cc of blood for generation of autologous dendritic cells who qualify the following conditions
- Body weight: 50 kg or above for men, 45 kg or above for women
- Hb level of 12.0 g/dL or above 5) Signed the written consent form for this clinical trial
Who cannot join
- Volunteers who correspond to any of the following conditions
- LV thrombus
- Difficulty in accessing femoral artery for sheath insertion due to peripheral artery disease
- Previous history of PCI, CABG due to myocardial infarction
- Renal failure: serum Creatinine >2.5 mg/dL
- Acute or chronic infections
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- Known contraindications to MRI
- Hemorrhagic disorders (PT INR >2)
- History of malignant tumor within 5 years
- A life expectancy of 1 year or less
- Tested positive with HIV, HBV, HCV and/or syphilis
- Autoimmune disease
- Pregnant or nursing mothers
- Participated in other clinical trials within past 30 days
- Deemed unfit for this clinical trial by the investigators
- Disagreed to use an approved method of contraception (Men: vasectomy, double diaphragm, or effective contraception used by the partner. Women: IUD, IUS or hormonal contraceptives) during the trial period.
- Moderate-to-severe liver disease (ALT is more than 5 times the upper limit of normal)
- Acute myocardial infarction patients at high bleeding risk with Hb 11g/dL or more Use or are scheduled to use oral anticoagulants for a long period of time Spontaneous hemorrhage that required hospitalization or blood transfusion within the past 6 months Thrombocytopenia (platelet count of <100x109/L) Liver cirrhosis with portal hypertension Severe ischemic stroke within the past 6 months, with spontaneous intracerebral hemorrhage and cerebrovascular malformation Major surgery or severe injury within the past 30 days
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Eun Ho Choo
Seoul, 137-701
Eun Ho Choo, +82222588206, cmcchu@catholic.ac.kr
About this study
Official title: A Multi-center, Controlled, Open, Phase I Clinical Trial to Assess the Safety of AMI-DC (Autologous Dendritic Cells) Treatment in Patients With Acute Anterior Wall ST-segment Elevation Myocardial Infarction Who Received Reperfusion by Primary Percutaneous Coronary Intervention (PCI)
The purpose of this trial is to assess the safety of AMI-DC treatment. The participants who voluntarily sign the consent form will be screened according to the inclusion/exclusion criteria then allocated either to the experimental group (drug therapy and AMI-DC therapy) or to the control group (drug therapy only). Both the experimental group and the control group are treated with standard medical therapy after PCI. The experimental group will be hospitalized for 4-5 days after 1st injection, and 1 day after 2nd injection. Vital signs are collected after 30 minutes, 1 hour, 2 hours and 4 hours after the 1st and 2nd injections and the subjects will be monitored 24 hours for safety assessment. The identical examination will also be performed in the control group and the results will be collected.
Read the detailed description
The registration of study subjects follows two stages (stages A \& B). In Stage A, 6 subjects in the experimental group and 3 subjects in the control group will sequentially be registered, then will be monitored for 10 weeks to assess safety. If Stage A passes the safety assessment, the rest will be recruited and randomly allocated to either experimental or control group in Stage B.
Approximately 300cc of whole blood will be collected only from patients assigned to the experimental group. The amount of blood collection can be supervised and adjusted at the discretion of the investigators. Collected blood will be cultured for 4 days to generate the dendritic cells. Then, 5~10x106 cells are administered subcutaneously at 1-4 sites in the left axillary regions between 5-7 days after PCI and between 12-14 days after PCI.
Echocardiography and cardiac MRI will be examined for any signs of adverse reaction to ensure safety and evaluate cardiac functions at baseline and after 6 months.
- In stage A, 6 people are sequentially allocated to the experimental group and 3 people are sequentially allocated to the control group.
- The experimental group are monitored for 10 weeks following the 2nd AMI-DC to assess safety. Stage B is implemented once determined safe to proceed.
- Conditions
- Myocardial Infarction
- Being tested
- Autologous peripheral blood-derived tolerogenic dendritic cells
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous peripheral blood-derived tolerogenic dendritic cellsBiological
AMI-DC, autologous dendritic cell product Inject 7.5 x 106 cells hypodermically to 1~4 sites in the left axillary lymph node between 5-7 days after PCI and 12-14 days after PCI. . The administration must be done within 30 minutes after fully liquified.
| Study group | Role | What they receive |
|---|---|---|
| AMI-DC | Experimental | Infusion of AMI-DC + Guideline directed optimal medical therapy Receives: Biological: Autologous peripheral blood-derived tolerogenic dendritic cells |
| Standard treatment | No intervention | Control, Guideline directed optimal medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Outcome 1
Occurrence of Ventricular Arrhythmias, Perforation, Myocardial Ischemia, or Any sign of infection that occur during the entire study period
Measured: Up to 6 months
Primary Safety Outcome 2
Occurrence of Ventricular Arrhythmia or Bradyarrhythmia in 24-hour Holter monitoring at 12 weeks.
Measured: Week 12
Primary Efficacy Outcome
Cumulated incidence ratio of MACE (death from any cause, HF admission, VT/VF, stroke) at 6 months
Measured: up to 6 months
Secondary outcomes (10)
Change in infarct size
Change in infarct size measured by MRI between the baseline and 6 months.
Measured: up to 6 months
Change in left ventricular ejection fraction
Changes in left ventricular ejection fraction (in percent) by echocardiography/MRI between the baseline and 6 months.
Measured: up to 6 months
Change in LV chamber
Changes in left ventricular end-systolic (milliliter)/end-diastolic volume (milliliter) measured by echocardiography/MRI between the baseline and 6 months.
Measured: up to 6 months
Change in LV wall motion
Changes in WMSI measured by echocardiography/MRI between the baseline and 6 months.
Measured: up to 6 months
Change in polarization of lymphocyte by FACS
Changes in polarization of lymphocyte by FACS (in percentage) at baseline (before the 1st AMI-DC administration), before the 2nd AMI-DC administration, at 3 weeks, and at 12 weeks.
Measured: up to 12 weeks
Change in serum cytokine
Changes in IL-1, TNF-a, IL-6, and IL-10 (in picogram per milliliter) by ELISA at baseline (before the 1st AMI-DC administration), before the 2nd AMI-DC administration, at 3 weeks, and at 12 weeks.
Measured: up to 12 weeks
Change in white blood cell count
Changes in white blood cell count, neurtrophil count, and lymphocyte (number per liter) count between the baseline and 6 months.
Measured: up to 6 months
Change in C-reactive protein (CRP)
Changes in CRP (milligram per liter) between the baseline and 6 months.
Measured: up to 6 months
Change in NT-proBNP
Changes in NT-pro-BNP (picogram per liter) between the baseline and 6 months.
Measured: up to 6 months
Change in patients' HF symptom
Changes in NYHA functional class at each visit
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start7 Jun 2021
- Primary completion1 Jul 2023 (estimated)
- Study completion30 Oct 2023 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stage A (Sequential allocation): 6 for experimental group, 3 for control group Stage B (Randomized allocation): 9 for experimental group, 12 for control group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kiyuk Chang, MD,PhD, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554484
- Sponsor's protocol ID
- AMI-DC
- Acronym
- AMI-DC
- Status last verified
- Sep 2022
- First submitted
- 2 Sep 2022
- Last updated
- 26 Sep 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 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Controlled, Open, Phase I Clinical Trial to Assess the Safety of AMI-DC (Autologous Dendritic Cells) Treatment in Patients With Acute Anterior Wall ST-segment Elevation Myocardial Infarction Who Received Reperfusion by Primary Percutaneous Coronary Intervention (PCI)
- ClinicalTrials.gov ID
- NCT05554484
- Acronym / sponsor ID
- AMI-DC / AMI-DC
- Conditions
- Myocardial Infarction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 26 Sep 2022 (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 purpose of this trial is to assess the safety of AMI-DC treatment. The participants who voluntarily sign the consent form will be screened according to the inclusion/exclusion criteria then allocated either to the experimental group (drug therapy and AMI-DC therapy) or to the control group (drug therapy only). Both the experimental group and the control group are treated with standard medical therapy after PCI. The experimental group will be hospitalized for 4-5 days after 1st injection, and 1 day after 2nd injection. Vital signs are collected after 30 minutes, 1 hour, 2 hours and 4 hours after the 1st and 2nd injections and the subjects will be monitored 24 hours for safety assessment. The identical examination will also be performed in the control group and the results will be collected.
Detailed description
The registration of study subjects follows two stages (stages A \& B). In Stage A, 6 subjects in the experimental group and 3 subjects in the control group will sequentially be registered, then will be monitored for 10 weeks to assess safety. If Stage A passes the safety assessment, the rest will be recruited and randomly allocated to either experimental or control group in Stage B.
Approximately 300cc of whole blood will be collected only from patients assigned to the experimental group. The amount of blood collection can be supervised and adjusted at the discretion of the investigators. Collected blood will be cultured for 4 days to generate the dendritic cells. Then, 5~10x106 cells are administered subcutaneously at 1-4 sites in the left axillary regions between 5-7 days after PCI and between 12-14 days after PCI.
Echocardiography and cardiac MRI will be examined for any signs of adverse reaction to ensure safety and evaluate cardiac functions at baseline and after 6 months.
- In stage A, 6 people are sequentially allocated to the experimental group and 3 people are sequentially allocated to the control group.
- The experimental group are monitored for 10 weeks following the 2nd AMI-DC to assess safety. Stage B is implemented once determined safe to proceed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stage A (Sequential allocation): 6 for experimental group, 3 for control group Stage B (Randomized allocation): 9 for experimental group, 12 for control group
| Arm | Type | Receives |
|---|---|---|
| AMI-DC | Experimental | Biological: Autologous peripheral blood-derived tolerogenic dendritic cellsInfusion of AMI-DC + Guideline directed optimal medical therapy |
| Standard treatment | No intervention | –Control, Guideline directed optimal medical therapy |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Volunteers who qualify all the following conditions
- Patients within 24 hours from primary PCI with a diagnosis of acute anterior wall ST-segment elevation myocardial infarction and systolic dysfunction:
- acute myocardial infarction patient with an electrocardiogram (12-lead ECG) result corresponding to any of the following (ST-segment elevation 0.1 mV in two or more limb leads or 0.2 mV elevation in two or more contiguous precordial leads)
- Body weight: 50 kg or above for men, 45 kg or above for women
- Hb level of 12.0 g/dL or above 5) Signed the written consent form for this clinical trial
Key exclusion criteria (18 listed)
- Volunteers who correspond to any of the following conditions
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-derived tolerogenic dendritic cellsAMI-DC, autologous dendritic cell product Inject 7.5 x 106 cells hypodermically to 1~4 sites in the left axillary lymph node between 5-7 days after PCI and 12-14 days after PCI. . The administration must be done within 30 minutes after fully liquified. | Biological | AMI-DC |
Primary outcome
Primary Safety Outcome 1
Time frame: Up to 6 months
Occurrence of Ventricular Arrhythmias, Perforation, Myocardial Ischemia, or Any sign of infection that occur during the entire study period
Primary Safety Outcome 2
Time frame: Week 12
Occurrence of Ventricular Arrhythmia or Bradyarrhythmia in 24-hour Holter monitoring at 12 weeks.
Primary Efficacy Outcome
Time frame: up to 6 months
Cumulated incidence ratio of MACE (death from any cause, HF admission, VT/VF, stroke) at 6 months
10 secondary outcomes
Change in infarct size
Time frame: up to 6 months
Change in left ventricular ejection fraction
Time frame: up to 6 months
Change in LV chamber
Time frame: up to 6 months
Change in LV wall motion
Time frame: up to 6 months
Change in polarization of lymphocyte by FACS
Time frame: up to 12 weeks
Change in serum cytokine
Time frame: up to 12 weeks
Change in white blood cell count
Time frame: up to 6 months
Change in C-reactive protein (CRP)
Time frame: up to 6 months
Change in NT-proBNP
Time frame: up to 6 months
Change in patients' HF symptom
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 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.
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 Autologous peripheral blood-derived tolerogenic dendritic cells in people with Myocardial Infarction, run by The Catholic University of Korea 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 9 inclusion and 18 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 26 Sep 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 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eun Ho Choo, M/D/ (+82222588206, cmcchu@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Outcome 1 (time frame: Up to 6 months). The study lists 3 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 26 Sep 2022; AzTrials last refreshed its copy on 7 Nov 2026.