RecruitingPhase 3NCT06364150

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


Sponsor

Seoul National Hospital

Enrollment

30 participants

Start Date

Jul 15, 2024

Study Type

INTERVENTIONAL

Conditions

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".


Eligibility

Min Age: 19 YearsMax Age: 80 Years

Inclusion Criteria4

  • \. 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.

Exclusion Criteria10

  • 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

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Interventions

BIOLOGICALAutologous 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.


Locations(1)

Seoul National University Hospital

Seoul, South Korea

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NCT06364150


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