NCT06731933PHASE2Recruiting
Impact of COL7A1 Gene Therapy on SCC Recurrence in RDEB Skin
Stanford University
Start Date
3/28/2025
Completion Date
2/1/2027
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.
Eligibility Criteria
Age Range: 18 years to No maximum
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.
Interventions
DRUG
BVEC
Conditions
Squamous Cell Carcinoma
Locations
Stanford University
Redwood City, California 94063
United States
Azienda Ospedliero-Universitaia
Bari,
Italy