Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT02579369
Status:
COMPLETED
Last Update Posted:
2023-08-25
First Post:
2015-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Dystrophic Epidermolysis Bullosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016108', 'term': 'Epidermolysis Bullosa Dystrophica'}, {'id': 'D004820', 'term': 'Epidermolysis Bullosa'}], 'ancestors': [{'id': 'D012868', 'term': 'Skin Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D003095', 'term': 'Collagen Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D012872', 'term': 'Skin Diseases, Vesiculobullous'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-23', 'studyFirstSubmitDate': '2015-10-16', 'studyFirstSubmitQcDate': '2015-10-16', 'lastUpdatePostDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area of re-epithelization', 'timeFrame': 'Follow up to 8 weeks'}], 'secondaryOutcomes': [{'measure': "Percentage of a target wound's re-epithelialization", 'timeFrame': 'Every time of visit for follow up to 8 weeks'}, {'measure': 'Time taken to re-epithelization', 'timeFrame': 'Over 8 weeks'}, {'measure': 'Safety assessed by clinically measured abnormality of laboratory tests and adverse events', 'timeFrame': 'Over 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Epidermolysis Bullosa', 'stem cell'], 'conditions': ['Dystrophic Epidermolysis Bullosa']}, 'descriptionModule': {'briefSummary': 'This is a phase I/II open-label study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Dystrophic Epidermolysis Bullosa.', '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 an new option in treating a Dystrophic Epidermolysis Bullosa.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age : 10\\~60\n2. Diagnosed with Dystrophic Epidermolysis Bullosa based on immunofluorescence test.\n3. Bullous skin lesion sized over 10 cm\\^2\n4. Test negative for Serum β-HCG pregnancy test on screening, if the subject is fertile\n5. A subject who is willing to follow the protocol and provide a informed consent on screening, given that the information with respect to the clinical trial is provided.\n\nExclusion Criteria:\n\n1. A subject with history of epidermoid carcinoma within a year from screening.\n2. A subject who requires antibiotics due to bacterial infection on skin.\n3. A subject who was dosed with oral steroid, over 0.5mg/kg a day for subjects under 18, or over 20mg in 2 weeks for subjects over 18, within 30 days prior to screening.\n4. A subject treated with radiotherapy or immunosuppressants, within 30 days prior to screening.\n5. A subject treated with steroids locally, within 30 days prior to screening.\n6. A subject with 2-times the maximum-standardized value of ALT, AST, ALP, bilirubin, total protein\n7. A subject with 2-times the maximum-standardized value of BUN, Creatinine\n8. A subject with Albumin below 2.0 g/dL.\n9. A subject with Hemoglobin below 6 g/dL (anemic).\n10. A subject with allergic response to bovine derived protein and fibrin glue.\n11. A subject administered with biologic agents or cell therapy, within 30 days prior to screening.\n12. A subject administered with stem cell treatment by IV or subcutaneously to the target wound, prior to the trial\n13. A subject who enrolled into another clinical trial, within 30 days prior to screening\n14. A subject with serious disease that can affect on clinical trial.\n15. A pregnant or breast-feeding subject.\n16. A subject with history of drug abuse within 1 year of clinical significance\n17. A subject who cannot proceed according to the protocol.'}, 'identificationModule': {'nctId': 'NCT02579369', 'briefTitle': 'Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Dystrophic Epidermolysis Bullosa', 'organization': {'class': 'INDUSTRY', 'fullName': 'Anterogen Co., Ltd.'}, 'officialTitle': 'A Phase 1/2 Clinical Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Dystrophic Epidermolysis Bullosa', 'orgStudyIdInfo': {'id': 'ALLO-ASC-EB-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ALLO-ASC-DFU', 'interventionNames': ['Other: Allogeneic mesenchymal stem cells']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Therapy', 'interventionNames': ['Device: Polyurethene Film']}], 'interventions': [{'name': 'Allogeneic mesenchymal stem cells', 'type': 'OTHER', 'otherNames': ['ALLO-ASC-DFU'], 'description': 'Dressing for Dystrophic Epidermolysis Bullosa wound.', 'armGroupLabels': ['ALLO-ASC-DFU']}, {'name': 'Polyurethene Film', 'type': 'DEVICE', 'description': 'Dressing for Dystrophic Epidermolysis Bullosa wound.', 'armGroupLabels': ['Conventional Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-720', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Gangnam Severence Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Su Chan Kim, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gangnam Severence Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anterogen Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}