{ "data": { "asOf": "2026-10-30T22:25:18.111Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT07193134", "title": "GMEB-SASS: A Gene-Modified Skin Substitute for RDEB Treatment", "scientificTitle": "Genetically Modified Epidermolysis Bullosa Self-Assembled Skin Substitute (GMEB-SASS) to Treat Patients Suffering From Recessive Dystrophic Epidermolysis Bullosa (RDEB)", "status": "recruiting", "studyType": "interventional", "phase": [ "PHASE1", "PHASE2" ], "conditions": [ "RDEB", "Recessive Dystrophic Epidermolysis Bullosa", "Epidermolysis Bullosa Dystrophica, Recessive" ], "interventions": [ { "name": "Genetically Modified Epidermolysis Bullosa Self-Assembled Skin Substitute (GMEB-SASS)", "type": "DRUG", "description": "Wound debridement will be performed, followed by the application of temporary allogeneic skin grafts for 3-5 days. The allografts will then be removed, and the GMEB-SASS grafts will be applied." } ], "sponsor": { "name": "CHU de Quebec-Universite Laval", "type": "OTHER" }, "locations": [ { "city": "Toronto", "country": "Canada", "facility": "The Hospital for Sick Children (SickKids)" } ], "outcomes": { "other": [ "Quality of Life Epidermolysis Bullosa (QOLEB) questionnaire", "Quality-of-life EQ-5D questionnaire", "Quality-of-life iscorEB questionnaire - patient portion", "Scar evaluation - Vancouver scar scale (VSS)", "Participant's self-perception about the persistence of healing in the treated areas", "Participant's self-perception of how easily the skin blisters in the treated areas", "Type VII collagen protein expression", "Autoantibody against type VII collagen", "Economic impact evaluation" ], "primary": [ "Adverse events", "Pain score changes using a Visual Analogue Scale (VAS)", "Itch score changes using a Visual Analogue Scale (VAS)" ], "secondary": [ "Percentage of the grafted GMEB-SASS surface area that has healed", "iscorEB questionnaire - clinician portion", "Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI)" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\n* Age\n\nLearning phase:\n\n* Subjects 1 to 3: Eighteen (18) years old or older.\n* Subjects 4 to 6: Twelve (12) years old or older.\n* Subjects 7 to 9: Seven (7) years old or older.\n\nOther Inclusion Criteria:\n\n* Clinical diagnosis of recessive dystrophic epidermolysis bullosa (RDEB) with confirmed biallelic pathogenic variant in the COL7A1 gene.\n* Candidates - or their parents/caregivers if the candidates have limited comprehension, who are able to understand the study and to comply with the study procedures.\n* On the day of grafting, one or more blistered and/or erosive skin areas on the trunk and/or extremities large enough to graft at least three 25 to 50 cm2 GMEB-SASS grafts.\n* Ability to undergo anesthesia.\n\nExclusion Criteria:\n\n* Medical instability limiting the ability to travel to the investigative center.\n* Any medical condition or illness that may impact study participation or compromise the safety of the participants, as per the investigator's judgment.\n* Evidence of systemic infection.\n* Current evidence or a history of non-metastatic or metastatic squamous cell carcinoma at the site to be grafted.\n* Any clinically significant abnormal laboratory values or abnormal findings identified during physical examination or through medical history that could compromise participant safety, as per the investigator's judgment.\n* History of or known allergy to bovine proteins.\n* Active drug or alcohol addiction.\n* Female candidate who are pregnant or breast-feeding.\n* Candidate who has received immunotherapy, including oral corticosteroids (Prednisolone \\> 1 mg/kg), for more than one week, within 2 weeks prior to the study intervention (initial biopsy and GMEB-SASS grafting) (intranasal and topical preparations are permitted).\n* Candidate who has received chemotherapy within 60 days prior to the study intervention (initial biopsy and GMEB-SASS grafting).\n* Candidate who has received, in the last 6 months prior to the study intervention (initial biopsy and GMEB-SASS grafting), any gene therapy, chemical or biological product modifying collagen 7 expression.", "minimumAge": "7 Years", "healthyVolunteers": false }, "enrollment": { "type": "ESTIMATED", "count": 9 }, "startDate": "2026-01-07", "completionDate": "2035-12-01", "lastUpdated": "2026-03-18T00:00:00.000Z", "firstPosted": "2025-09-25T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT07193134" ] }, "identifiers": [ { "idType": "nct", "idValue": "NCT07193134", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07193134", "sourceUrl": "https://clinicaltrials.gov/study/NCT07193134", "sourceStatus": "RECRUITING", "retrievedAt": "2026-10-07T04:31:51.499Z", "payloadSha256": "5f0cace28d33b12817fc4ae0809063cc9bc689094ad5a5c025c5e994a1382e55", "piiRedacted": true } ], "citation": { "canonicalId": "NCT07193134", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07193134", "verifyAt": "https://clinicaltrials.gov/study/NCT07193134", "retrievedAt": "2026-10-07T04:31:51.499Z", "payloadSha256": "5f0cace28d33b12817fc4ae0809063cc9bc689094ad5a5c025c5e994a1382e55", "text": "ClinicalTrials.gov, record NCT07193134 (https://clinicaltrials.gov/study/NCT07193134), retrieved 2026-10-07, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "text": "Trial NCT07193134, registered in ClinicalTrials.gov, retrieved 2026-10-07. 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