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

NCT ID: NCT06364150

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-15

Study Completion Date

2026-08-01

Brief Summary

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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".

Detailed Description

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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.

Conditions

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Acute Myocardial Infarction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a single arm, open label interventional study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cell treatment arm

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

Group Type EXPERIMENTAL

Autologous Peripheral Blood Stem Cell injection

Intervention Type 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.

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role collaborator

Seoul National Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hyun-Jai Cho

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyun Jai Cho, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jeehoon Kang, MD

Role: CONTACT

+821024162406

Facility Contacts

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Jeehoon Kang, MD, PhD

Role: primary

+82-2-2072-1181

Hyun-Jai Cho, MD, PhD

Role: backup

Other Identifiers

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MAGIC6

Identifier Type: -

Identifier Source: org_study_id