title: Fibroblast cell therapy enhances initial healing in recessive dystrophic epidermolysis bullosa wounds: results of a randomized, vehicle-controlled trial.
abstract: BACKGROUND
  Fibroblast cell therapy can modify disease biology in recessive dystrophic epidermolysis bullosa (RDEB) although whether it improves wound healing is not clear.
  
  
  OBJECTIVE
  To assess the effects of injecting of allogeneic fibroblasts into the margins of chronic erosions in individuals with RDEB in a prospective, double-blind, randomized, vehicle-controlled phase II trial.
  
  
  METHODS
  Erosions were randomized 1:1, to either a single treatment of 5 × 10(6) fibroblasts per linear cm of erosion margin or vehicle. All subjects continued standard wound care. The trial sponsor, participants and study outcome assessor were masked to treatment allocation. A hierarchy of endpoints germane to erosion closure was assessed.
  
  
  RESULTS
  Twenty-six erosions in 11 subjects with RDEB were injected; 14 erosions received fibroblasts and 12 vehicle alone. A single series of injections was given at day 0 and all follow-up visits were completed. Treatment difference between fibroblasts and vehicle was -23.5% [95% confidence interval (CI) -3.5 to -43.5, P = 0.025] at day 7, -19.15% (95% CI 3.36 to -41.66, P = 0.089) at day 14 and -28.83% (95% CI 7.97 to -65.63, P = 0.11) at day 28. Beyond day 28, however, changes in mean erosion area did not differ significantly between the two groups.
  
  
  CONCLUSIONS
  A single intradermal injection of allogeneic fibroblasts increases the initial rate of erosion healing in subjects with RDEB within the first 28 days but not thereafter. Further studies are needed to address the potential benefits of retreatment as well as optimal cell delivery.
authors.affiliation: St John's Institute of Dermatology, King's College London (Guy's Campus), London, SE1 9RT, U.K.
authors.forename: G
authors.initials: G
authors.lastname: Petrof
authors.forename: M
authors.initials: M
authors.lastname: Martinez-Queipo
authors.forename: J E
authors.initials: JE
authors.lastname: Mellerio
authors.forename: P
authors.initials: P
authors.lastname: Kemp
authors.forename: J A
authors.initials: JA
authors.lastname: McGrath
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D064987:Cell- and Tissue-Based Therapy / Q000379:methods*; D004311:Double-Blind Method; D016108:Epidermolysis Bullosa Dystrophica / Q000628:therapy*; D005260:Female; D005347:Fibroblasts / Q000637:transplantation*; D006801:Humans; D007271:Injections, Intradermal; D008297:Male; D008875:Middle Aged; D014677:Pharmaceutical Vehicles / Q000008:administration & dosage; D011446:Prospective Studies; D011788:Quality of Life; D016896:Treatment Outcome; D014945:Wound Healing / Q000502:physiology; D055815:Young Adult
chemical_list: D014677:Pharmaceutical Vehicles