Date Updated
EB Type
Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Name of Company
Fibrocell Science
Recruitment Status
Active, Not Recruiting
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 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.

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 click the link below for exclusion criteria.

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