Impact of COL7A1 Gene Therapy on SCC Recurrence in RDEB Skin

Recruiting now · Phase 2

Conditions studied: Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT06731933

Run by

Stanford University

People needed

16

Starts

2025-03-28

Expected to finish

2027-02-01

Last updated by the study team

2026-04-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Stanford University — Redwood City, California, United States (enrolling)
• Azienda Ospedliero-Universitaia — Bari, Italy (enrolling)

Full record on ClinicalTrials.gov

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