Language: BG BG
← Back to results
Recruiting Phase 2 NCT06731933

Impact of COL7A1 Gene Therapy on SCC Recurrence in RDEB Skin

Phase 2 – studying effectiveness and dosage
Conditions: Squamous Cell Carcinoma

Sponsor: Stanford University

trial.available_in: БГ
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.
Who can participate
Inclusion 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 Exclusion Criteria: 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.
Interventions
BVEC
DRUG
Locations 2
Italy (1)
Azienda Ospedliero-Universitaia
Bari
United States (1)
Stanford University
Redwood City , California
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
28.03.2025
Completion date
01.02.2027
Registry ID
NCT06731933
Source
clinicaltrials.gov
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.