AMI-DC in Patients With Anterior Wall Myocardial Infarction

NCT05554484 | Unknown Phase 1 DMC

• 1 other identifier: AMI-DC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (3)

• Primary Safety Outcome 1

  Occurrence of Ventricular Arrhythmias, Perforation, Myocardial Ischemia, or Any sign of infection that occur during the entire study period

  Up to 6 months

• Primary Safety Outcome 2

  Occurrence of Ventricular Arrhythmia or Bradyarrhythmia in 24-hour Holter monitoring at 12 weeks.

  Week 12

• Primary Efficacy Outcome

  Cumulated incidence ratio of MACE (death from any cause, HF admission, VT/VF, stroke) at 6 months

  up to 6 months

Secondary Outcomes (10)

• Change in infarct size

  up to 6 months

• Change in left ventricular ejection fraction

  up to 6 months

• Change in LV chamber

  up to 6 months

• Change in LV wall motion

  up to 6 months

• Change in polarization of lymphocyte by FACS

  up to 12 weeks

Study Arms (2)

AMI-DC

EXPERIMENTAL

Infusion of AMI-DC + Guideline directed optimal medical therapy

Biological: Autologous peripheral blood-derived tolerogenic dendritic cells

Standard treatment

NO INTERVENTION

Control, Guideline directed optimal medical therapy

Interventions

Autologous peripheral blood-derived tolerogenic dendritic cells BIOLOGICAL

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.

AMI-DC

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Catholic University of Korea: lead

Study Sites (1)

Eun Ho Choo

Seoul, 137-701, South Korea

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Eun Ho Choo, M/D/

CONTACT

+82222588206; cmcchu@catholic.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Stage A (Sequential allocation): 6 for experimental group, 3 for control group Stage B (Randomized allocation): 9 for experimental group, 12 for control group

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 26, 2022
• Study Start: June 7, 2021
• Primary Completion: July 1, 2023
• Study Completion: October 30, 2023
• Last Updated: September 26, 2022

Record last verified: 2022-09

Locations

KR (1)