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

Seoul National Hospital

Status and phase: Not yet enrolling; Phase 3

Conditions: Acute Myocardial Infarction

Treatments: Biological: Autologous Peripheral Blood Stem Cell injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06364150

MAGIC6

Details and patient eligibility

About

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".

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Cell treatment arm

Experimental group

Description:

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

Treatment:

Biological: Autologous Peripheral Blood Stem Cell injection