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

No results posted yet for this study

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
  • Stanford University

    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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06731933 on ClinicalTrials.gov