Fibrocell Science Inc's Phase I/II Study of FCX-007 for Recessive Dystrophic EB
Below you will find updated information about the Fibrocell Science Inc.’s active EB trial. The purpose of this study is to evaluate the safety of FCX-007, evaluate C7 expression and the presence of anchoring fibrils resulting from FCX-007 and to analyze wound healing as a result of FCX-007 administration in subjects with RDEB.
About the study
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 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.
Trial Entry Criteria
- 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 visit www.clinicaltrials.gov for exclusion criteria.
For further information about the study, or to participate, click here.