A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Epidermolysis Bullosa Dystrophica, Recessive
About this trial
This is an interventional treatment trial for Epidermolysis Bullosa Dystrophica, Recessive focused on measuring RDEB
Eligibility Criteria
Key Inclusion Criteria:
Age
- Phase I: Eighteen (18) years or older.
- Phase II: Seven (7) years or older.
- Diagnosis of recessive dystrophic epidermolysis bullosa (RDEB)
Key Exclusion Criteria:
- Medical instability limiting ability to travel to the investigative center.
- Active infection with HIV, hepatitis B or hepatitis C or evidence of other systemic infection
- Current evidence of metastatic squamous cell carcinoma at the site to be injected
- Clinically significant abnormal laboratory result or other significant clinical abnormalities
- Receipt of a chemical or biological study product for the specific treatment of RDEB in the past six months
Sites / Locations
- Stanford University
- Children's Hospital Colorado
Arms of the Study
Arm 1
Experimental
FCX-007
In Phase I, a target of three adult subjects will be enrolled into Group A and a target of three adult subjects will be enrolled into Group B. In Phase II the study will target enrolling subjects (aged seven (7 years or older) to each arm, but will allow a disproportionate distribution of subjects between Group A and Group B to equal approximately 6 total subjects. All subjects will receive FCX-007 into one or more paired target wounds as well as to intact skin at least one time during the study with a possible second administration pending laboratory results. One wound in each target wound pair will be used as control for efficacy and safety evaluations.