Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2025-12-29 @ 5:59 PM
Study NCT ID:
NCT06364150
Status:
RECRUITING
Last Update Posted:
2024-12-03
First Post:
2024-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Use of Angiopoietin-Primed Autologous Peripheral Blood Stem Cell in Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a single arm, open label interventional study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-27', 'studyFirstSubmitDate': '2024-03-28', 'studyFirstSubmitQcDate': '2024-04-10', 'lastUpdatePostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left ventricular systolic function', 'timeFrame': '12 months after treatment', 'description': 'Left ventricular ejection fraction measured by echocardiography (measured in percent)'}], 'secondaryOutcomes': [{'measure': 'Regional wall motion score index', 'timeFrame': '12 months after treatment', 'description': '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.'}, {'measure': 'B-natriuretic peptide level', 'timeFrame': '12 months after treatment', 'description': 'Laboratory test which is measured in picograms per milliliter (pg/ml).'}, {'measure': '6-minute walk test', 'timeFrame': '12 months after treatment', 'description': '6-minute walk test is measured in meters.'}, {'measure': 'All-cause death', 'timeFrame': '12 months after treatment', 'description': 'Rate of patients with a mortality event due to any cause'}, {'measure': 'Target lesion Revascularization', 'timeFrame': '12 months after treatment', 'description': 'Rate of patients who received additional revascularization for the target lesion (the coronary lesion that was treated at the index procedure)'}, {'measure': 'Readmssion', 'timeFrame': '12 months after treatment', 'description': 'Rate of patients who were readmitted due to any cause'}, {'measure': 'Cardiovascular death', 'timeFrame': '12 months after treatment', 'description': 'Rate of patients with a mortality event due to cardiovascular cause'}, {'measure': 'non-Target lesion Revascularization', 'timeFrame': '12 months after treatment', 'description': 'Rate of patients who received additional revascularization for a non-target lesion (the coronary lesion that was NOT treated at the index procedure)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peripheral Blood Stem Cell Treatment', 'Acute Myocardial Infarction'], 'conditions': ['Acute Myocardial Infarction']}, 'descriptionModule': {'briefSummary': '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".', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Male and female aged ≥19 years and ≤ 80 years\n* 2\\. A clinical diagnosis of acute myocardial infarction within 4 weeks from randomization\n* 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\n* 4\\. Agreement to give written informed consent.\n\nExclusion Criteria:\n\n1. Patients with uncontrolled heart failure (Killip class ≥ grade 2, or left ventricular ejection fraction \\<20%)\n2. Patients with uncontrolled chest pain due to ischemia\n3. Patients with uncontrolled arrythmia\n4. Active malignancy, or incompletely treated malignancy\n5. Active infectious disease\n6. Uncontrolled hematologic disease, including coagulopathy or bleeding diathesis\n7. Presence of non-cardiac comorbidity with life expectancy ≤1 year from randomization\n8. Females with childbearing potential or breast-feeding\n9. Refusal to give written informed consent\n10. Other conditions that may result in protocol non-compliance by the committees'}, 'identificationModule': {'nctId': 'NCT06364150', 'acronym': 'MAGICcell6', 'briefTitle': 'Therapeutic Use of Angiopoietin-Primed Autologous Peripheral Blood Stem Cell in Myocardial Infarction', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Seoul National Hospital'}, 'officialTitle': 'Therapeutic Use of Angiopoietin-Primed Autologous Peripheral Blood Stem Cell in Myocardial Infarction', 'orgStudyIdInfo': {'id': 'MAGIC6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cell treatment arm', 'description': 'Patients who receive Angiopoietin-Primed Autologous Peripheral Blood Stem Cell in Myocardial Infarction', 'interventionNames': ['Biological: Autologous Peripheral Blood Stem Cell injection']}], 'interventions': [{'name': 'Autologous Peripheral Blood Stem Cell injection', 'type': 'BIOLOGICAL', 'description': '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.', 'armGroupLabels': ['Cell treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jeehoon Kang, MD, PhD', 'role': 'CONTACT', 'email': 'medikang@gmail.com', 'phone': '+82-2-2072-1181'}, {'name': 'Hyun-Jai Cho, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jeehoon Kang, MD', 'role': 'CONTACT', 'email': 'medikang@gmail.com', 'phone': '+821024162406'}], 'overallOfficials': [{'name': 'Hyun Jai Cho, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Any request for data sharing should be sent as an inquiry to the principle investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Seoul National University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hyun-Jai Cho', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}