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NCT Number: NCT06364150

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

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".

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Key information

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Hyun-Jai Cho, MD, PhD

CONTACT

Jeehoon Kang, MD, PhD

CONTACT

[email protected]

+82-2-2072-1181

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Left ventricular systolic function

    Time frame: 12 months after treatment

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

Secondary outcomes

  1. Regional wall motion score index

    Time frame: 12 months after treatment

    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.

  2. B-natriuretic peptide level

    Time frame: 12 months after treatment

    Laboratory test which is measured in picograms per milliliter (pg/ml).

  3. 6-minute walk test

    Time frame: 12 months after treatment

    6-minute walk test is measured in meters.

  4. All-cause death

    Time frame: 12 months after treatment

    Rate of patients with a mortality event due to any cause

  5. Target lesion Revascularization

    Time frame: 12 months after treatment

    Rate of patients who received additional revascularization for the target lesion (the coronary lesion that was treated at the index procedure)

  6. Readmssion

    Time frame: 12 months after treatment

    Rate of patients who were readmitted due to any cause

  7. Cardiovascular death

    Time frame: 12 months after treatment

    Rate of patients with a mortality event due to cardiovascular cause

  8. non-Target lesion Revascularization

    Time frame: 12 months after treatment

    Rate of patients who received additional revascularization for a non-target lesion (the coronary lesion that was NOT treated at the index procedure)

Study contacts

Contact information is provided by the study sponsor or research team.

Jeehoon Kang, MD

CONTACT

[email protected]

+821024162406

Sponsors and collaborators

Lead sponsor

Seoul National Hospital

Other Gov

Collaborators

  • Seoul National University Hospital

Registry information

Acronym: MAGICcell6

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 15, 2024
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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