Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:24 AM
Study NCT ID:
NCT07400458
Status:
RECRUITING
Last Update Posted:
2026-02-10
First Post:
2024-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Follow-up Study Following the Approval of Hearticellgram-AMI Administration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2032-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-06', 'studyFirstSubmitDate': '2024-05-09', 'studyFirstSubmitQcDate': '2026-02-06', 'lastUpdatePostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-10-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of AESI', 'timeFrame': 'For 5 years', 'description': 'death, neoplasms or malignancies in tissues or organs, Immune response'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'This Long-term follow-up is designed to evaluate the safety of patient with Acute Myocardial Infarction who had administered Hearticellgram-AMI.', 'detailedDescription': 'To evaluate the safety for 60 months after a single dose of Hearticellgram-AMI in patients with Acute Myocardial Infarction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Those who had administered Hearticellgram-AMI\n2. Those who voluntarily agreed in writing to participate in this investigation\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07400458', 'briefTitle': 'Long-term Follow-up Study Following the Approval of Hearticellgram-AMI Administration', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pharmicell Co., Ltd.'}, 'officialTitle': 'Long-term Follow-up Study Following the Approval of Hearticellgram-AMI Administration to Evaluate Its Safety in Patients With Acute Myocardial Infarction', 'orgStudyIdInfo': {'id': 'PMC-P-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hearticellgram-AMI', 'description': 'Patients with Acute Myocardial Infarction who had administered Hearticellgram-AMI.', 'interventionNames': ['Biological: Hearticellgram-AMI']}], 'interventions': [{'name': 'Hearticellgram-AMI', 'type': 'BIOLOGICAL', 'description': 'Patients who had administered Hearticellgram-AMI.', 'armGroupLabels': ['Hearticellgram-AMI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06017', 'city': 'Seoul', 'state': 'Gangnam', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'HYUNSOO KIM', 'role': 'CONTACT', 'phone': '82-2-511-1101'}], 'facility': 'KIMHYUNSOO Clinic', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'DAEUN JUNG', 'role': 'CONTACT', 'email': 'daeun4100@pharmicell.com', 'phone': '82-2-3496-0134'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pharmicell Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}