Impact of COL7A1 Gene Therapy on SCC Recurrence in RDEB Skin
Sponsor: Stanford University
ClinicalTrials ID:NCT06731933
This clinical trial evaluates the effect of BVEC gene therapy on reducing SCC recurrence in RDEB patients. Eligible participants must have COL7A1 mutations, biopsy-confirmed SCC, and be 18 or older. US participants will receive BVEC at home, while those in Bari, Italy, will not. Informed consent and effective contraception are required.
Patient Parameters
| Parameter | Options |
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Program Overview
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
Inclusion Criteria
- Diagnosis of generalized Recessive dystrophic epidermolysis bullosa (RDEB) demonstrated by COL7A1 mutations
- Presence of biopsy proven squamous cell carcinoma (SCC)
- Ability to understand and the willingness to provide written informed consent.
- US based participants are willing to use beremagene geperpavec (BVEC)
- Subject is 18 years or older
- participant willingness to use an effective method of contraception
Exclusion Criteria
- Inability to travel to site for study visit
- Subject is pregnant
- Subject has Metastatic SCC's or is on any current systemic treatment for SCC.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Stanford University | 94063 | Redwood City | California |
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