Clinical trial NCT06364150: Therapeutic Use of Angiopoietin-Primed Autologous Peripheral Blood Stem Cell in Myocardial Infarction
Official title: Therapeutic Use of Angiopoietin-Primed Autologous Peripheral Blood Stem Cell in Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Acute Myocardial Infarction
Keywords: Peripheral Blood Stem Cell Treatment
Acute Myocardial Infarction
Lead sponsor: Seoul National Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Seoul National University Hospital
First posted: 2024-04-15
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single arm, open label interventional study
Primary purpose: TREATMENT

Brief 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".

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Left ventricular systolic function
timeFrame: 12 months after treatment
Secondary outcomes:
measure: Regional wall motion score index
timeFrame: 12 months after treatment
measure: B-natriuretic peptide level
timeFrame: 12 months after treatment
measure: 6-minute walk test
timeFrame: 12 months after treatment
measure: All-cause death
timeFrame: 12 months after treatment
measure: Target lesion Revascularization
timeFrame: 12 months after treatment
measure: Readmssion
timeFrame: 12 months after treatment
measure: Cardiovascular death
timeFrame: 12 months after treatment
measure: non-Target lesion Revascularization
timeFrame: 12 months after treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hyun Jai Cho, MD
role: PRINCIPAL_INVESTIGATOR
References: