Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT04590703
Status:
COMPLETED
Last Update Posted:
2023-08-25
First Post:
2020-09-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-301 Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}], 'ancestors': [{'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-24', 'studyFirstSubmitDate': '2020-09-28', 'studyFirstSubmitQcDate': '2020-10-09', 'lastUpdatePostDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of systemic tolerance through incidence of abnormal laboratory test results', 'timeFrame': 'Up to 9 months'}, {'measure': 'Evaluation of incidence of clinically significant change in physical examination and vital signs', 'timeFrame': 'Up to 18 months'}, {'measure': 'Evaluation of localized tolerance through incidence of clinically significant change about treatment area', 'timeFrame': 'Up to 24 months'}, {'measure': 'Evaluation of incidence of adverse events', 'timeFrame': 'Up to 24 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Foot Ulcer']}, 'descriptionModule': {'briefSummary': 'This is a follow-up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-301) for 24 months', 'detailedDescription': 'This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-301) for 24 months. ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a Diabetic Foot Ulcer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects who are treated with ALLO-ASC-DFU sheet or Vehicle sheet in phase 3 clinical trial of ALLO-ASC-DFU-301.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects who are treated with ALLO-ASC-DFU sheet or Vehicle sheet in phase 3 clinical trial of ALLO-ASC-DFU-301.\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': 'NCT04590703', 'briefTitle': 'A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-301 Clinical Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Anterogen Co., Ltd.'}, 'officialTitle': 'A Follow-up Study to Evaluate the Safety for the Patients With ALLO-ASC-DFU Treatment in Phase 3 Clinical Trial of ALLO-ASC-DFU-301', 'orgStudyIdInfo': {'id': 'ALLO-ASC-DFU-303'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ALLO-ASC-DFU', 'description': 'Subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial of ALLO-ASC-DFU-301', 'interventionNames': ['Biological: ALLO-ASC-DFU']}, {'label': 'Vehicle sheet', 'description': 'Subjects with Vehicle sheet treatment in phase 3 clinical trial of ALLO-ASC-DFU-301', 'interventionNames': ['Procedure: Vehicle sheet']}], 'interventions': [{'name': 'ALLO-ASC-DFU', 'type': 'BIOLOGICAL', 'description': 'Application of ALLO-ASC-DFU sheet to Diabetic Foot Ulcer. This study is a follow-up study without intervention.', 'armGroupLabels': ['ALLO-ASC-DFU']}, {'name': 'Vehicle sheet', 'type': 'PROCEDURE', 'description': 'Application of Vehicle sheet to Diabetic Foot Ulcer. This study is a follow-up study without intervention.', 'armGroupLabels': ['Vehicle sheet']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Daejeon', 'state': 'Chungcheongnam-do', 'country': 'South Korea', 'facility': 'Chungnam National University Hospital'}, {'zip': '14584', 'city': 'Bucheon-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Soonchunhyang University Hospital', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'zip': '13620', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '16499', 'city': 'Suwon', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Ajou University Medical Center', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'zip': '42601', 'city': 'Daegu', 'state': 'Gyeongsangnam-do', 'country': 'South Korea', 'facility': 'Keimyung University Dongsan Medical Center'}, {'zip': '01830', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Nowon Eulji Medical Center, Eulji University', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08308', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'SeungKyu Han, MD. Ph D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University Guro Hospital'}, {'name': 'KiWon Young, MD. Ph D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nowon Eulji Medical Center, Eulji University'}, {'name': 'JunPyo Hong, MD. Ph D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}, {'name': 'JunHyeong Kim, MD. Ph D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Keimyung University Dongsan Medical Center'}, {'name': 'Chan Kang, MD. Ph D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chungnam National University Hospital'}, {'name': 'HyungMin Hahn, MD. Ph D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ajou University Medical Center'}, {'name': 'ChanYeong Heo, MD. Ph D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}, {'name': 'YoungKoo Lee, MD. Ph D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soonchunhyang University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anterogen Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}