Impact of COL7A1 Gene Therapy on SCC Recurrence in RDEB Skin
NCT06731933 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16
Last 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.
Conditions
Interventions
- DRUG
-
BVEC
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.
Sponsors & Collaborators
-
Epidermolysis Bullosa Research Partnership
collaborator OTHER_GOV - lead OTHER
Principal Investigators
-
Peter Marinkovich, MD · Stanford University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-28
- Primary Completion
- 2027-02-28
- Completion
- 2027-02-28
- FDA Drug
- Yes
Countries
- United States
- Italy
Study Locations
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