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

NCT06364150 | Recruiting Phase 3

• 1 other identifier: MAGIC6
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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".

Conditions

Acute Myocardial Infarction

Keywords

Peripheral Blood Stem Cell Treatment; Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Left ventricular systolic function

  Left ventricular ejection fraction measured by echocardiography (measured in percent)

  12 months after treatment

Secondary Outcomes (8)

• Regional wall motion score index

  12 months after treatment

• B-natriuretic peptide level

  12 months after treatment

• 6-minute walk test

  12 months after treatment

• All-cause death

  12 months after treatment

• Target lesion Revascularization

  12 months after treatment

Study Arms (1)

Cell treatment arm

EXPERIMENTAL

Patients who receive Angiopoietin-Primed Autologous Peripheral Blood Stem Cell in Myocardial Infarction

Biological: Autologous Peripheral Blood Stem Cell injection

Interventions

Autologous Peripheral Blood Stem Cell injection BIOLOGICAL

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.

Cell treatment arm

Eligibility Criteria

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

You may qualify if:

• \. Male and female aged ≥19 years and ≤ 80 years
• \. A clinical diagnosis of acute myocardial infarction within 4 weeks from randomization
• \. 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
• \. Agreement to give written informed consent.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Seoul National Hospital: lead
• Seoul National University Hospital: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Study Officials

• Hyun Jai Cho, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeehoon Kang, MD

CONTACT

+821024162406; medikang@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a single arm, open label interventional study

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 15, 2024
• Study Start: July 15, 2024
• Primary Completion: May 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)