Impact of COL7A1 Gene Therapy on SCC Recurrence in RDEB Skin

Part of paid clinical trials in Redwood City, California.

Sponsor
Stanford University
Study ID
NCT06731933
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BVEC — DRUG
    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.

Study Details

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.

Key Dates

First listed
Dec 13, 2024
Start date
Mar 28, 2025
Status verified
Apr 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
16 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Treatment with BVEC
  • No Intervention: No treatment with BVEC

Primary Outcome Measure

Recurrence rate of Squamous Cell Carcinoma [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityRedwood CityCalifornia94063
Kunju Sridhar
[email protected]
650-721-4902
Peter M Marinkovich, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Redwood City, CA

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By condition
Skin cancer
By specialty
OncologySkin cancerDermatology
By research site
Stanford University· Redwood City, CA

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