title: Double-blind placebo-controlled study of autologous transplanted epidermal cell suspensions for repigmenting vitiligo.
abstract: OBJECTIVE
  To investigate the efficacy of epidermal noncultured cellular grafting in patients with vitiligo and the role of postinflammatory, spontaneous, or UV-induced pigmentation in obtaining repigmentation.
  
  
  METHODS
  A prospective, randomized, double-blind, placebo-controlled study.
  
  
  METHODS
  Ambulatory patients in an institutional practice. Patients were followed up for 3 to 12 months.
  
  
  METHODS
  A total of 33 paired, symmetrically distributed leukodermic lesions, all resistant to therapy, were observed in 28 patients. Nineteen patients appeared to have a stable vitiligo (group 1), whereas there was doubt about the stability of the disease in 9 patients (group 2).
  
  
  METHODS
  After laser ablation, a hyaluronic acid-enriched cellular graft was applied to 1 lesion while the paired lesion received placebo. Three weeks later all lesions were exposed to UV irradiation twice per week for approximately 2 months.
  
  
  METHODS
  Primarily, the percentage of repigmentation was assessed after 3, 6, and 12 months using a digital image analysis system. The repigmentation pattern was also evaluated after 1 and 3 months.
  
  
  RESULTS
  A strongly significant difference between cellular grafts and placebo was observed after 3, 6, and 12 months (P<.001, P = .002, and P = .002, respectively). In group 1, repigmentation of at least 70% of the treated area was achieved in 55%, 57%, and 77% of the actively treated lesions 3, 6, and 12 months after treatment, whereas in group 2 repigmentation of at least 70% of the treated area was not observed at any time point. The repigmentation pattern was diffuse in 94% of the responding patients.
  
  
  CONCLUSIONS
  After a strict preoperative selection for disease stability, transplantation resulted in repigmentation of at least 70% of the treated area in most actively treated vitiligo lesions. Repigmentation was primarily caused by the transplanted melanocytes.
authors.affiliation: Department of Dermatology, Ghent University Hospital, 9000 Ghent, Belgium.
authors.forename: Nanny
authors.initials: N
authors.lastname: van Geel
authors.forename: Katia
authors.initials: K
authors.lastname: Ongenae
authors.forename: Martine
authors.initials: M
authors.lastname: De Mil
authors.forename: Yves Vander
authors.initials: YV
authors.lastname: Haeghen
authors.forename: Chris
authors.initials: C
authors.lastname: Vervaet
authors.forename: Jean Marie
authors.initials: JM
authors.lastname: Naeyaert
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002478:Cells, Cultured / Q000637:transplantation; D004311:Double-Blind Method; D000078404:Epidermal Cells; D004817:Epidermis / Q000637:transplantation*; D005260:Female; D006801:Humans; D053685:Laser Therapy; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012880:Skin Pigmentation; D013535:Suspensions; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D014820:Vitiligo / Q000473:pathology / Q000601:surgery*
chemical_list: D013535:Suspensions