Ignite Creation Date:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2026-01-31 @ 5:30 AM
Study NCT ID:
NCT04171661
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-13
First Post:
2019-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Self-Assembled Skin Substitute for the Treatment of Epidermolysis Bullosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016108', 'term': 'Epidermolysis Bullosa Dystrophica'}], 'ancestors': [{'id': 'D004820', 'term': 'Epidermolysis Bullosa'}, {'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': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'n-of-one'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2019-11-19', 'studyFirstSubmitQcDate': '2019-11-19', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent reduction in wound surface area', 'timeFrame': '2 weeks', 'description': 'Clinical assessment'}], 'secondaryOutcomes': [{'measure': 'Graft failure', 'timeFrame': '2 weeks', 'description': 'Clinical assessment'}, {'measure': 'Number of subsequent re-transplantation', 'timeFrame': '3 years', 'description': 'Number'}, {'measure': 'Time (in weeks) to 50% reduction in the surface area of the wounds;', 'timeFrame': '3 years', 'description': 'Clinical assessment'}, {'measure': 'Time (in weeks) to complete healing', 'timeFrame': '3 years', 'description': 'Clinical assessment'}, {'measure': 'Changes in pain scores', 'timeFrame': '3 years', 'description': '10 point visual analog scale where 0 is none and 10 the worst pain'}, {'measure': 'Changes in itch scores where 0 is none and 10 the worst itch', 'timeFrame': '3 years', 'description': '10 point scale'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dystrophic Epidermolysis Bullosa', 'Recessive Dystrophic Epidermolysis Bullosa', 'Tissue Engineering', 'Skin Substitute'], 'conditions': ['Epidermolysis Bullosa Dystrophica']}, 'descriptionModule': {'briefSummary': 'Single patient study. Patient diagnosed with dystrophic epidermolysis bullosa presenting chronic open wounds that are not responding to dressings, topical preparations (antimicrobials, antibiotics) and systemic agents (anti-inflammatory antibacterials). The Self-Assembled Skin Substitutes will be used to cover wounds.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'This clinical trial was custom designed for one patient'}, 'identificationModule': {'nctId': 'NCT04171661', 'acronym': 'SASS', 'briefTitle': 'Self-Assembled Skin Substitute for the Treatment of Epidermolysis Bullosa', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Quebec-Universite Laval'}, 'officialTitle': 'SASS 3: Self-Assembled Skin Substitute (SASS) for the Treatment of Epidermolysis Bullosa', 'orgStudyIdInfo': {'id': 'LOEX 019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SASS', 'description': 'SASS applied on chronic skin wounds as skin graft', 'interventionNames': ['Biological: SASS']}], 'interventions': [{'name': 'SASS', 'type': 'BIOLOGICAL', 'description': 'SASS applied on chronic skin wounds as skin graft', 'armGroupLabels': ['SASS']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Quebec-Universite Laval', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Hospital for Sick Children', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}