Impact of COL7A1 Gene Therapy on SCC Recurrence in RDEB Skin

Description

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

Squamous Cell Carcinoma

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Study Overview

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Study Details

Study overview

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.

Impact of Collagen VII Gene Therapy on Squamous Cell Carcinoma Recurrence in Recessive Dystrophic Epidermolysis Bullosa Skin

Impact of COL7A1 Gene Therapy on SCC Recurrence in RDEB Skin

Condition
Squamous Cell Carcinoma
Intervention / Treatment

-

Contacts and Locations

Redwood City

Stanford University, Redwood City, California, United States, 94063

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Diagnosis of generalized Recessive dystrophic epidermolysis bullosa (RDEB) demonstrated by COL7A1 mutations
  • 2. Presence of biopsy proven squamous cell carcinoma (SCC)
  • 3. Ability to understand and the willingness to provide written informed consent.
  • 4. US based participants are willing to use beremagene geperpavec (BVEC)
  • 5. Subject is 18 years or older
  • 6. participant willingness to use an effective method of contraception
  • 1. Inability to travel to site for study visit
  • 2. Subject is pregnant
  • 3. Subject has Metastatic SCC's or is on any current systemic treatment for SCC.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Stanford University,

Peter Marinkovich, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

2027-02