Therapeutic Use of Angiopoietin-Primed Autologous Peripheral Blood Stem Cell in Myocardial Infarction
Seoul National Hospital
30 participants
Jul 15, 2024
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
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
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)
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NCT06364150