Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-21 @ 6:40 AM
Study NCT ID:
NCT02619851
Status:
COMPLETED
Last Update Posted:
2023-08-25
First Post:
2015-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Evaluate the Safety and Efficacy of ALLO-ASC-DFU for Second Deep Degree Burn Injury Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-23', 'studyFirstSubmitDate': '2015-11-30', 'studyFirstSubmitQcDate': '2015-12-01', 'lastUpdatePostDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time of re-epithelialization', 'timeFrame': 'Follow up to 12 weeks', 'description': 'Time of re-epithelialization'}], 'secondaryOutcomes': [{'measure': 'Safety (laboratory tests and adverse events)', 'timeFrame': 'Follow up to 12 weeks', 'description': 'Clinically measured abnormality of laboratory tests and adverse events'}, {'measure': 'Burn Scar Index', 'timeFrame': 'Follow up to 12 weeks', 'description': 'Vancouver Burn Scar Scale'}, {'measure': 'healing status of the wound evidenced by photography', 'timeFrame': 'follow up to 12 weeks', 'description': 'healing status of the wound evidenced by photography'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Burn Injury']}, 'descriptionModule': {'briefSummary': 'This clinical trial is a Phase II controlled, parallel, open-label trial, designed to test the efficacy and safety of ALLO-ASC-DFU and conventional therapy in Deep Second-degree burn wound subjects.', 'detailedDescription': '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 Deep Second-degree burn wounds.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject is 18 years of age and older.\n2. Subjects who have deep second-degree burn wound ≥100cm\\^2.\n3. TBSA(Total burn surface area) ≤ 30%\n4. Negative for Urine beta-HCG for women of childbearing age.\n5. Subject is able to give written informed consent prior to study start and comply with the study requirements.\n\nExclusion Criteria:\n\n1. Subject who have been enrolled in another clinical study within 30 days of screening.\n2. Subjects who are allergic or have a hypersensitive reaction to bovine-derived proteins or fibrin glue.\n3. Subjects who are receiving steroids, immunosuppressive, or anticoagulant for long term\n4. Subjects with active infection.\n5. Subjects with hemorrhagic and hemocoagulative disease.\n6. Subjects who are unwilling to use an "effective" method of contraception during the study.\n7. Subjects who have a history of malignant tumor within the last five years, or is currently undergoing.\n8. Subjects who are pregnant or breast-feeding.\n9. Subjects who are considered to have a significant disease which can impact the wound healing by the investigator\n10. Burn wound is present on any part of the face.\n11. Subjects who are considered not suitable for the study by the investigator.\n12. Subjects who are not able to understand the objective of this study or to comply with the study requirements'}, 'identificationModule': {'nctId': 'NCT02619851', 'briefTitle': 'A Clinical Trial to Evaluate the Safety and Efficacy of ALLO-ASC-DFU for Second Deep Degree Burn Injury Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Anterogen Co., Ltd.'}, 'officialTitle': 'A Phase II Clinical Trial to Evaluate the Safety and Efficacy of ALLO-ASC-DFU for Second Deep Degree Burn Injury Subjects: Controlled, Parallel, Multicenter', 'orgStudyIdInfo': {'id': 'ALLO-ASC-BI-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ALLO-ASC-DFU', 'description': 'Allogeneic mesenchymal stem cells', 'interventionNames': ['Biological: ALLO-ASC-DFU']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Therapy', 'description': 'Typical therapy conducted for burn injury patients', 'interventionNames': ['Device: Conventional Therapy']}], 'interventions': [{'name': 'ALLO-ASC-DFU', 'type': 'BIOLOGICAL', 'otherNames': ['Allogeneic mesenchymal stem cells'], 'description': 'Dressing for Second Deep degree Burn injury', 'armGroupLabels': ['ALLO-ASC-DFU']}, {'name': 'Conventional Therapy', 'type': 'DEVICE', 'description': 'Typical therapy conducted for burn injury patients', 'armGroupLabels': ['Conventional Therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hallym university Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Wook Chun, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hallym University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anterogen Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}