RECRUITINGPhase 3INTERVENTIONAL
Therapeutic Use of Angiopoietin-Primed Autologous Peripheral Blood Stem Cell in Myocardial Infarction
About This Trial
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".
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form.
Who Should NOT Join This Trial:
1. Patients with uncontrolled heart failure (Killip class ≥ grade 2, or left ventricular ejection fraction \<20%)
2. Patients with uncontrolled chest pain due to ischemia
3. Patients with uncontrolled arrythmia
4. Active malignancy, or incompletely treated malignancy
5. Active infectious disease
6. Uncontrolled hematologic disease, including coagulopathy or bleeding diathesis
7. Presence of non-cardiac comorbidity with life expectancy ≤1 year from randomization
8. Females with childbearing potential or breast-feeding
9. Refusal to give written willing to sign a consent form
10. Other conditions that may result in protocol non-compliance by the committees
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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:
1. Patients with uncontrolled heart failure (Killip class ≥ grade 2, or left ventricular ejection fraction \<20%)
2. Patients with uncontrolled chest pain due to ischemia
3. Patients with uncontrolled arrythmia
4. Active malignancy, or incompletely treated malignancy
5. Active infectious disease
6. Uncontrolled hematologic disease, including coagulopathy or bleeding diathesis
7. Presence of non-cardiac comorbidity with life expectancy ≤1 year from randomization
8. Females with childbearing potential or breast-feeding
9. Refusal to give written informed consent
10. Other conditions that may result in protocol non-compliance by the committees
Treatments Being Tested
BIOLOGICAL
Autologous 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