Therapeutic Use of Angiopoietin-Primed Autologous Peripheral Blood Stem Cell in Myocardial Infarction

Acute Myocardial Infarction Clinical Trial

— MAGICcell6  

Official title:

Therapeutic Use of Angiopoietin-Primed Autologous Peripheral Blood Stem Cell in Myocardial Infarction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06364150
• Other study ID #: MAGIC6
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 1, 2024
• Est. completion date: August 1, 2026

Study information

• Verified date: April 2024
• Source: Seoul National Hospital
• Contact: Jeehoon Kang, MD
• Phone: +821024162406
• Email: medikang[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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".

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 1, 2026
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

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

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular systolic function	Left ventricular ejection fraction measured by echocardiography (measured in percent)	12 months after treatment
Secondary	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.	12 months after treatment
Secondary	B-natriuretic peptide level	Laboratory test which is measured in picograms per milliliter (pg/ml).	12 months after treatment
Secondary	6-minute walk test	6-minute walk test is measured in meters.	12 months after treatment
Secondary	All-cause death	Rate of patients with a mortality event due to any cause	12 months after treatment
Secondary	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
Secondary	Readmssion	Rate of patients who were readmitted due to any cause	12 months after treatment
Secondary	Cardiovascular death	Rate of patients with a mortality event due to cardiovascular cause	12 months after treatment
Secondary	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