Therapeutic Use of Angiopoietin-Primed Autologous Peripheral Blood Stem Cell in Myocardial Infarction (MAGICcell6)

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".

Study Overview

• Status: Recruiting
• Conditions: Acute Myocardial Infarction
• Intervention / Treatment: Biological: Autologous Peripheral Blood Stem Cell injection

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jeehoon Kang, MD; Phone Number: +821024162406; Email: medikang@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: Jeehoon Kang, MD, PhD; Phone Number: +82-2-2072-1181; Email: medikang@gmail.com
    • Contact: Hyun-Jai Cho, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

1. Patients with uncontrolled heart failure (Killip class ≥ grade 2, or left ventricular ejection fraction <20%)
2. Patients with uncontrolled chest pain due to ischemia
3. Patients with uncontrolled arrythmia
4. Active malignancy, or incompletely treated malignancy
5. Active infectious disease
6. Uncontrolled hematologic disease, including coagulopathy or bleeding diathesis
7. Presence of non-cardiac comorbidity with life expectancy ≤1 year from randomization
8. Females with childbearing potential or breast-feeding
9. Refusal to give written informed consent
10. Other conditions that may result in protocol non-compliance by the committees

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cell treatment arm; Patients who receive Angiopoietin-Primed Autologous Peripheral Blood Stem Cell in Myocardial Infarction	Biological: Autologous Peripheral Blood Stem Cell injection; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left ventricular systolic function	Left ventricular ejection fraction measured by echocardiography (measured in percent)	12 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months after treatment
B-natriuretic peptide level	Laboratory test which is measured in picograms per milliliter (pg/ml).	12 months after treatment
6-minute walk test	6-minute walk test is measured in meters.	12 months after treatment
All-cause death	Rate of patients with a mortality event due to any cause	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)	12 months after treatment
Readmssion	Rate of patients who were readmitted due to any cause	12 months after treatment
Cardiovascular death	Rate of patients with a mortality event due to cardiovascular cause	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)	12 months after treatment

Collaborators and Investigators

• Sponsor: Seoul National Hospital
• Collaborators: Seoul National University Hospital
• Investigators: Principal Investigator: Hyun Jai Cho, MD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: April 10, 2024
• First Posted (Actual): April 15, 2024

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Acute Myocardial Infarction; Peripheral Blood Stem Cell Treatment
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Necrosis; Myocardial Ischemia; Ischemia; Myocardial Infarction; Infarction
• Other Study ID Numbers: MAGIC6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Any request for data sharing should be sent as an inquiry to the principle investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No