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.
Stanford is currently not accepting patients for this trial.
Fibrocell Technologies, Inc.
- Biological: FCX-007 (debcoemagene 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