Trial Search Results
A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (RDEB)
The purpose of this study is to evaluate the safety of FCX-007, evaluate Type VII collagen (COL7) expression and the presence of anchoring fibrils and to analyze wound healing as a result of FCX-007 administration in subjects with recessive dystrophic epidermolysis bullosa (RDEB). Funding Source- FDA OOPD
Stanford is currently accepting patients for this trial.
Castle Creek Biosciences, LLC.
- Genetic: FCX-007
Phase 1/Phase 2
Key Inclusion Criteria:
1. Phase I: Eighteen (18) years or older.
2. Phase II: Seven (7) years or older.
2. Diagnosis of recessive dystrophic epidermolysis bullosa (RDEB)
Key Exclusion Criteria:
1. Medical instability limiting ability to travel to the investigative center.
2. Active infection with HIV, hepatitis B or hepatitis C or evidence of other systemic
3. Current evidence of metastatic squamous cell carcinoma at the site to be injected
4. Clinically significant abnormal laboratory result or other significant clinical
5. Receipt of a chemical or biological study product for the specific treatment of RDEB
in the past six months
Ages Eligible for Study
7 Years - N/A
Genders Eligible for Study