Seoul National University Hospital
Seoul, South Korea
Location status: Recruiting
NCT Number: NCT06364150
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".
Interested in participating?
Request Info19 year–80 year
All sexes
Interventional
Phase 3
Seoul, South Korea
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 12 months after treatment
Left ventricular ejection fraction measured by echocardiography (measured in percent)
Time frame: 12 months after treatment
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
Laboratory test which is measured in picograms per milliliter (pg/ml).
Time frame: 12 months after treatment
6-minute walk test is measured in meters.
Time frame: 12 months after treatment
Rate of patients with a mortality event due to any cause
Time frame: 12 months after treatment
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
Rate of patients who were readmitted due to any cause
Time frame: 12 months after treatment
Rate of patients with a mortality event due to cardiovascular cause
Time frame: 12 months after treatment
Rate of patients who received additional revascularization for a non-target lesion (the coronary lesion that was NOT treated at the index procedure)
Contact information is provided by the study sponsor or research team.
Seoul National Hospital
Other Gov
Acronym: MAGICcell6
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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