RecruitingPhase 2

Impact of COL7A1 Gene Therapy on SCC Recurrence in RDEB Skin

United States, Italy16 participantsStarted 2025-03-28

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Recurrence rate of Squamous Cell Carcinoma

Timeframe: 2 years

Trial details

NCT IDNCT06731933

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02

Contact for this trial

Kunju Sridhar

650-721-4902 kunju@stanford.edu

View on ClinicalTrials.gov More Squamous Cell Carcinoma trials