Trials / Recruiting
RecruitingNCT06731933
Impact of COL7A1 Gene Therapy on SCC Recurrence in RDEB Skin
Impact of Collagen VII Gene Therapy on Squamous Cell Carcinoma Recurrence in Recessive Dystrophic Epidermolysis Bullosa Skin
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- Sponsor
- Stanford University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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. |
Timeline
- Start date
- 2025-03-28
- Primary completion
- 2027-02-01
- Completion
- 2027-02-01
- First posted
- 2024-12-13
- Last updated
- 2025-04-16
Locations
2 sites across 2 countries: United States, Italy
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06731933. Inclusion in this directory is not an endorsement.