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".
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Seoul National University Hospital
Seoul, South Korea
RECRUITINGLeft ventricular systolic function
Left ventricular ejection fraction measured by echocardiography (measured in percent)
Time frame: 12 months after treatment
Regional wall motion score index
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.
Time frame: 12 months after treatment
B-natriuretic peptide level
Laboratory test which is measured in picograms per milliliter (pg/ml).
Time frame: 12 months after treatment
6-minute walk test
6-minute walk test is measured in meters.
Time frame: 12 months after treatment
All-cause death
Rate of patients with a mortality event due to any cause
Time frame: 12 months after treatment
Target lesion Revascularization
Rate of patients who received additional revascularization for the target lesion (the coronary lesion that was treated at the index procedure)
Time frame: 12 months after treatment
Readmssion
Rate of patients who were readmitted due to any cause
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Time frame: 12 months after treatment
Cardiovascular death
Rate of patients with a mortality event due to cardiovascular cause
Time frame: 12 months after treatment
non-Target lesion Revascularization
Rate of patients who received additional revascularization for a non-target lesion (the coronary lesion that was NOT treated at the index procedure)
Time frame: 12 months after treatment