Trial Search Results
A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa
The purpose of this study is to determine whether administration of FCX-007 in addition to standard of care improves wound healing as compared to standard of care alone (control) in children, adolescents, and adults with Recessive Dystrophic Epidermolysis Bullosa.
Funding Source - FDA OOPD
Stanford is currently not accepting patients for this trial.
Castle Creek Biosciences, LLC.
- Biological: FCX-007 (dabocemagene autoficel; see below for FCX-007 description)
Key Inclusion Criteria:
- Male or female ≥2 years of age at the Screening visit.
- Clinical diagnosis of RDEB with confirmation of COL7A1 genetic mutation.
Key Exclusion Criteria:
- Medical instability limiting ability to travel to the investigative site.
- Active infection with human immunodeficiency virus, hepatitis B or hepatitis C.
- The presence of COL7 antibodies.
- Evidence of systemic infection.
- Evidence or history of squamous cell carcinoma at the site to be injected.
- Evidence of or history of metastatic squamous cell carcinoma.
- Known allergy to any of the constituents of the product.
- Female who is pregnant or breastfeeding.
- Receipt of a chemical or biological intervention for the specific treatment of RDEB in
the past three (3) months prior to screening or anticipated/planned during the
screening and treatment period for this study.
Ages Eligible for Study
2 Years - N/A
Genders Eligible for Study