Impact of COL7A1 Gene Therapy on SCC Recurrence in RDEB Skin
NCT ID: NCT06731933
Last Updated: 2025-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
16 participants
INTERVENTIONAL
2025-03-28
2027-02-28
Brief Summary
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Prevention of SCC's in the RDEB subjects will increase their life span.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Treatment with BVEC
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.
No treatment with BVEC
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. Subject is pregnant
3. Subject has Metastatic SCC's or is on any current systemic treatment for SCC.
18 Years
ALL
No
Sponsors
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Epidermolysis Bullosa Research Partnership
OTHER_GOV
Stanford University
OTHER
Responsible Party
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Principal Investigators
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Peter Marinkovich, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University
Redwood City, California, United States
Azienda Ospedliero-Universitaia
Bari, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB-73906
Identifier Type: -
Identifier Source: org_study_id
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