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Taking people in United StatesPhase 2

Impact of COL7A1 Gene Therapy on SCC Recurrence in RDEB Skin

Key facts

Who runs it
Stanford University
Where
Redwood City, United StatesSee the siteAlso in 1 other country, 1 site
Trial code
Status
Recruiting
Phase
Phase 2
People taking part
16 people, planned
Started
28 Mar 2025
Expected to end
Feb 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • BVEC
Record updated
20 April 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • 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

Who cannot take part

  • 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 in United States

Also in 1 other country, 1 site

  • Stanford UniversityRedwood City, United StatesContact: Kunju SridharTaking people

About the trial

What the trial wants to find out

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.

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Prevention of SCC's in the RDEB subjects will increase their life span.

The 2 groups in the trial

  • Treatment with BVECExisting treatment, for comparison

    Treatment: BVEC

  • No treatment with BVECNo study treatment, for comparison

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Impact of Collagen VII Gene Therapy on Squamous Cell Carcinoma Recurrence in Recessive Dystrophic Epidermolysis Bullosa Skin
Record updated
20 April 2026