{ "data": { "asOf": "2026-10-30T22:25:44.806Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT03392909", "title": "Intravenous Gentamicin Therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB)", "scientificTitle": "Restoration of Full-Length Type VII Collagen in RDEB Patients With Nonsense Mutations After Intravenous Gentamicin Treatment", "status": "unknown", "studyType": "interventional", "phase": [ "PHASE1", "PHASE2" ], "conditions": [ "Recessive Dystrophic Epidermolysis Bullosa" ], "interventions": [ { "name": "Gentamicin", "type": "DRUG", "description": "Short-term intravenous gentamicin therapy should have the advantage of treating all of the patient's multiple skin wounds simultaneously. Six patients (three adults and 3 children) will receive intravenous gentamicin (7.5 mgs/kg) daily for 14 days and then stopped. Three adult patients will receive intravenous gentamicin (7.5mg/kg) biweekly for three months and then stopped." } ], "sponsor": { "name": "University of Southern California", "type": "OTHER" }, "locations": [ { "city": "Los Angeles", "country": "United States", "facility": "University of Southern California" } ], "outcomes": { "other": [], "primary": [ "Full-length type VII collagen expression", "Generation of anchoring fibrils", "Absence of gentamicin side effects" ], "secondary": [ "Improved Disease Activity scores", "Improved Quality of Life score" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, aged 7 and up can participate in the 14 day IV gentamicin trial. Male or female, aged 18 and up can participate in the 3 month IV gentamicin trial.\n* Been diagnosed with recessive dystrophic epidermolysis bullosa (RDEB) and with a nonsense mutation in the COL7A1 gene.\n* Immunofluorescence evaluation of skin biopsies reveals absence or decreased intensity of C7 expression at their DEJ (dermal epidermal junction) compared with normal human skin biopsies.\n* Cultured fibroblasts from patient skin synthesize and secrete full-length, 290kDa C7 alpha chains in the presence of supplemented gentamicin (400 μg/ml in culture).\n* Ability to sit or lie down for over 30 minutes for IV infusions. For those in the 3 month trial, to be willing to continue treatment at home under the supervision of licensed and trained infusion nurses.\n\nExclusion Criteria:\n\n* Recent exposure to gentamicin within the past 6 weeks.\n* Pre-existing known auditory impairment.\n* Pre-existing known renal impairment.\n* Pre-existing known allergies to aminoglycosides or sulfate compounds.\n* Pregnancy or lactation\n* Current use of medications with known ototoxicity or nephrotoxicity.\n* Current enrollment in another experimental clinical trial involving systemic treatment with C7 or C7 producing products for the treatment of RDEB.", "minimumAge": "7 Years", "healthyVolunteers": false }, "enrollment": { "type": "ESTIMATED", "count": 9 }, "startDate": "2018-07-05", "completionDate": "2023-12-01", "lastUpdated": "2022-11-03T00:00:00.000Z", "firstPosted": "2018-01-08T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT03392909" ] }, "identifiers": [ { "idType": "nct", "idValue": "NCT03392909", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT03392909", "sourceUrl": "https://clinicaltrials.gov/study/NCT03392909", "sourceStatus": "UNKNOWN", "retrievedAt": "2026-10-20T04:33:42.344Z", "payloadSha256": "b765f3eae4fff6a9583606b6594a29a4b9b6d765247d24f15afbe1742c8c098e", "piiRedacted": true } ], "citation": { "canonicalId": "NCT03392909", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT03392909", "verifyAt": "https://clinicaltrials.gov/study/NCT03392909", "retrievedAt": "2026-10-20T04:33:42.344Z", "payloadSha256": "b765f3eae4fff6a9583606b6594a29a4b9b6d765247d24f15afbe1742c8c098e", "text": "ClinicalTrials.gov, record NCT03392909 (https://clinicaltrials.gov/study/NCT03392909), retrieved 2026-10-20, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "text": "Trial NCT03392909, registered in ClinicalTrials.gov, retrieved 2026-10-20. 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