RDEB is a congenital and progressive orphan skin disease caused by the deficiency of the protein type VII collagen (COL7). The objective of this study is to evaluate the safety FCX-007 intradermal injections in RDEB subjects. Additionally, the trial will evaluate type VII collagen expression, the presence of anchoring fibrils resulting from FCX-007, as well evidence of wound healing.
Six adult subjects are expected to be treated with FCX-007 in the Phase I portion of the trial and six subjects age 7 or older in the Phase II portion of the trial. All subjects will receive FCX-007 to one or more paired target RDEB wounds. Proof of mechanism will be monitored through digital photography of target wounds and assays conducted on biopsies taken from target wounds.
- Participants must be ages 18+ years of age for Phase I
- Participants must be 7+ years of age for Phase II
- Participants must have a diagnosis of Recessive Dystrophic EB
- NC1/NC2 Status (to be tested if unknown)
- Subjects must be, in the opinion of the investigator, able to understand the study, co-operate with the study procedures and willing to return to the clinic for all of the required follow-up visits
- Please click the link below for exclusion criteria.