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RecruitingInterventionalPhase 2
Impact of Collagen VII Gene Therapy on Squamous Cell Carcinoma Recurrence in Recessive Dystrophic Epidermolysis Bullosa Skin
NCT ID: NCT06731933Sponsor: Stanford UniversityLast updated: 2026-04-20
Summary
The study objective is to see if BVEC induced C7 expression in Recessive Dystrophic Epidermolysis Bullosa (RDEB) skin following Squamous cell carcinoma (SCC) excision will normalize the invasive tumor microenvironment and reduce tumor recurrence. Prevention of SCC's in the RDEB subjects will increase their life span.
Arms & interventions
- DrugBVEC
The study drug will be administered by home nurse at Subjects home for the participants residing in US. No drug will be applied when at study site. The subjects enrolled in Bari, Italy will not be administered BVEC.
Outcome measures
Primary
Recurrence rate of Squamous Cell Carcinoma
The outcome measure is recurrence rate of SCC following BVEC application at each SCC lesion
Time frame: 2 years
Eligibility criteria
Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria:
1. Diagnosis of generalized Recessive dystrophic epidermolysis bullosa (RDEB) demonstrated by COL7A1 mutations
2. Presence of biopsy proven squamous cell carcinoma (SCC)
3. Ability to understand and the willingness to provide written informed consent.
4. US based participants are willing to use beremagene geperpavec (BVEC)
5. Subject is 18 years or older
6. participant willingness to use an effective method of contraception
Exclusion Criteria:
1. Inability to travel to site for study visit
2. Subject is pregnant
3. Subject has Metastatic SCC's or is on any current systemic treatment for SCC.
Study locations (1)
Stanford University
Redwood City, California, 94063
Peter M Marinkovich, MD · Principal Investigator