Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-04-11 @ 11:14 PM
Study NCT ID:
NCT03183661
Status:
RECRUITING
Last Update Posted:
2023-08-25
First Post:
2017-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in ALLO-ASC-CD-101 Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 9}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-23', 'studyFirstSubmitDate': '2017-06-08', 'studyFirstSubmitQcDate': '2017-06-08', 'lastUpdatePostDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': 'up to 36 months', 'description': 'Evaluation of AE'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Crohn Disease']}, 'descriptionModule': {'briefSummary': 'This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-CD injection in phase 1 clinical trial (ALLO-ASC-CD-101) for 36 months.', 'detailedDescription': "This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-CD injection in phase 1 clinical trial (ALLO-ASC-CD-101) for 36 months.\n\nALLO-ASC-CD is intravenous infusion containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells are directed to injured tissue, and reduce inflammation. Furthermore their immunomodulatory effects are significant for treating immune-related disease, such as crohn's disease. Finally, ALLO-ASC-CD may provide a new option in treating a crohn's disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subject is enrolled who are injected ALLO-ASC-CD intravenous infusion in phase 1 clinical trial of ALLO-ASC-CD-101.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects who are injected with ALLO-ASC-CD in phase 1 clinical trial of ALLO-ASC-CD-101.\n2. Subjects who are able to give written informed consent prior to study start and to comply with the study requirements.\n\nExclusion Criteria:\n\n1\\. Subjects who are considered not suitable for the study by the principal investigator.'}, 'identificationModule': {'nctId': 'NCT03183661', 'briefTitle': 'A Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in ALLO-ASC-CD-101 Clinical Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Anterogen Co., Ltd.'}, 'officialTitle': 'Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in the Subjects With Crohn´s Disease(ALLO-ASC-CD-101)', 'orgStudyIdInfo': {'id': 'ALLO-ASC-CD-102'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ALLO-ASC-CD injection', 'description': 'Subjects with ALLO-ASC-CD injection in phase 1 clinical trial of ALLOASC-CD-101', 'interventionNames': ['Biological: ALLO-ASC-CD']}], 'interventions': [{'name': 'ALLO-ASC-CD', 'type': 'BIOLOGICAL', 'otherNames': ['Allogenic adipose-derived mesenchymal stem cell'], 'description': "ALLO-ASC-CD is intravenous infusion containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells are directed to injured tissue, and reduce inflammation. Furthermore their immunomodulatory effects are significant for treating immune-related disease. Finally, ALLO-ASC-CD may provide a new option in treating a crohn's disease. This study is a follow-up study without intervention.", 'armGroupLabels': ['ALLO-ASC-CD injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Joosung Kim, MD, Ph.D.', 'role': 'CONTACT', 'email': 'jooskim@snu.ac.kr,'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'status': 'COMPLETED', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jae Hee Cheon, Ph D', 'role': 'CONTACT', 'email': 'GENIUSHEE@yuhs.ac'}], 'overallOfficials': [{'name': 'Jae Hee Cheon, Ph D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yonsei University'}, {'name': 'Joo Sung Kim, Ph D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}, {'name': 'Young Ho Kim, Ph D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anterogen Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}