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| Name | Class |
|---|---|
| Seoul National University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cell treatment arm | Experimental | Patients who receive Angiopoietin-Primed Autologous Peripheral Blood Stem Cell in Myocardial Infarction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular systolic function | Left ventricular ejection fraction measured by echocardiography (measured in percent) | 12 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeehoon Kang, MD | Contact | +821024162406 | medikang@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hyun Jai Cho, MD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
Any request for data sharing should be sent as an inquiry to the principle investigator.
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This is a single arm, open label interventional study
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| 12 months after treatment |
| B-natriuretic peptide level | Laboratory test which is measured in picograms per milliliter (pg/ml). | 12 months after treatment |
| 6-minute walk test | 6-minute walk test is measured in meters. | 12 months after treatment |
| All-cause death | Rate of patients with a mortality event due to any cause | 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) | 12 months after treatment |
| Readmssion | Rate of patients who were readmitted due to any cause | 12 months after treatment |
| Cardiovascular death | Rate of patients with a mortality event due to cardiovascular cause | 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) | 12 months after treatment |