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AMI-DC in Patients With Anterior Wall Myocardial Infarction (AMI-DC)

Primary Purpose

Myocardial Infarction

Status
Recruiting
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Autologous peripheral blood-derived tolerogenic dendritic cells
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Volunteers who qualify all the following conditions

    1. 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)

    2. Left ventricular ejection fraction (LVEF) below 50% by echocardiography
    3. Hemodynamically stable (SBP >100 mmHg, HR <110 bpm, SO2 >95%)
    4. 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

Exclusion Criteria:

  • Volunteers who correspond to any of the following conditions

    1. LV thrombus
    2. Difficulty in accessing femoral artery for sheath insertion due to peripheral artery disease
    3. Previous history of PCI, CABG due to myocardial infarction
    4. Renal failure: serum Creatinine >2.5 mg/dL
    5. Acute or chronic infections
    6. Known contraindications to MRI
    7. Hemorrhagic disorders (PT INR >2)
    8. History of malignant tumor within 5 years
    9. A life expectancy of 1 year or less
    10. Tested positive with HIV, HBV, HCV and/or syphilis
    11. Autoimmune disease
    12. Pregnant or nursing mothers
    13. Participated in other clinical trials within past 30 days
    14. Deemed unfit for this clinical trial by the investigators
    15. 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.
    16. Moderate-to-severe liver disease (ALT is more than 5 times the upper limit of normal)
    17. 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

Sites / Locations

  • Eun Ho ChooRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

AMI-DC

Standard treatment

Arm Description

Infusion of AMI-DC + Guideline directed optimal medical therapy

Control, Guideline directed optimal medical therapy

Outcomes

Primary Outcome Measures

Primary Safety Outcome 1
Occurrence of Ventricular Arrhythmias, Perforation, Myocardial Ischemia, or Any sign of infection that occur during the entire study period
Primary Safety Outcome 2
Occurrence of Ventricular Arrhythmia or Bradyarrhythmia in 24-hour Holter monitoring at 12 weeks.
Primary Efficacy Outcome
Cumulated incidence ratio of MACE (death from any cause, HF admission, VT/VF, stroke) at 6 months

Secondary Outcome Measures

Change in infarct size
Change in infarct size measured by MRI between the baseline and 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.
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.
Change in LV wall motion
Changes in WMSI measured by echocardiography/MRI between the baseline and 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.
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.
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.
Change in C-reactive protein (CRP)
Changes in CRP (milligram per liter) between the baseline and 6 months.
Change in NT-proBNP
Changes in NT-pro-BNP (picogram per liter) between the baseline and 6 months.
Change in patients' HF symptom
Changes in NYHA functional class at each visit

Full Information

First Posted
September 2, 2022
Last Updated
September 21, 2022
Sponsor
The Catholic University of Korea
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1. Study Identification

Unique Protocol Identification Number
NCT05554484
Brief Title
AMI-DC in Patients With Anterior Wall Myocardial Infarction
Acronym
AMI-DC
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AMI-DC
Arm Type
Experimental
Arm Description
Infusion of AMI-DC + Guideline directed optimal medical therapy
Arm Title
Standard treatment
Arm Type
No Intervention
Arm Description
Control, Guideline directed optimal medical therapy
Intervention Type
Biological
Intervention Name(s)
Autologous peripheral blood-derived tolerogenic dendritic cells
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Safety Outcome 1
Description
Occurrence of Ventricular Arrhythmias, Perforation, Myocardial Ischemia, or Any sign of infection that occur during the entire study period
Time Frame
Up to 6 months
Title
Primary Safety Outcome 2
Description
Occurrence of Ventricular Arrhythmia or Bradyarrhythmia in 24-hour Holter monitoring at 12 weeks.
Time Frame
Week 12
Title
Primary Efficacy Outcome
Description
Cumulated incidence ratio of MACE (death from any cause, HF admission, VT/VF, stroke) at 6 months
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Change in infarct size
Description
Change in infarct size measured by MRI between the baseline and 6 months.
Time Frame
up to 6 months
Title
Change in left ventricular ejection fraction
Description
Changes in left ventricular ejection fraction (in percent) by echocardiography/MRI between the baseline and 6 months.
Time Frame
up to 6 months
Title
Change in LV chamber
Description
Changes in left ventricular end-systolic (milliliter)/end-diastolic volume (milliliter) measured by echocardiography/MRI between the baseline and 6 months.
Time Frame
up to 6 months
Title
Change in LV wall motion
Description
Changes in WMSI measured by echocardiography/MRI between the baseline and 6 months.
Time Frame
up to 6 months
Title
Change in polarization of lymphocyte by FACS
Description
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.
Time Frame
up to 12 weeks
Title
Change in serum cytokine
Description
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.
Time Frame
up to 12 weeks
Title
Change in white blood cell count
Description
Changes in white blood cell count, neurtrophil count, and lymphocyte (number per liter) count between the baseline and 6 months.
Time Frame
up to 6 months
Title
Change in C-reactive protein (CRP)
Description
Changes in CRP (milligram per liter) between the baseline and 6 months.
Time Frame
up to 6 months
Title
Change in NT-proBNP
Description
Changes in NT-pro-BNP (picogram per liter) between the baseline and 6 months.
Time Frame
up to 6 months
Title
Change in patients' HF symptom
Description
Changes in NYHA functional class at each visit
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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%) 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 Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eun Ho Choo, M/D/
Phone
+82222588206
Email
cmcchu@catholic.ac.kr
Facility Information:
Facility Name
Eun Ho Choo
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun Ho Choo
Phone
+82222588206
Email
cmcchu@catholic.ac.kr

12. IPD Sharing Statement

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AMI-DC in Patients With Anterior Wall Myocardial Infarction

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