title: Ready-made allogeneic ABO-specific serum eye drops: production from regular male blood donors, clinical routine, safety and efficacy.
abstract: OBJECTIVE
  To overcome problems and delays of the preparation of autologous serum eye drops, a production line of ABO-specific allogeneic serum eye drops from male blood donors was set up in a blood bank. Feasibility, clinical routine, safety and efficacy were evaluated in a cohort of patients with severe ocular surface disorders.
  
  
  METHODS
  Serum was derived from 450 ml whole-blood donations from regular male blood donors, produced and tested according to good manufacturing practice and legislation regulating blood products in Denmark. Serum was diluted to 20% (v/v) with NaCl 0.9%, filtered, bottled, registered and stored at -30°C in the blood bank. Upon request, frozen ABO-identical serum drops in lots of 14 bottles could be provided immediately. Safety and efficacy were evaluated in 34 patients with severe ocular surface disease refractory to conventional medical therapy. Patients were treated six times daily for minimum 2-4 weeks. Objective findings and subjective symptoms were compared between day 0 and after 4 weeks of treatment using the Wilcoxon signed-rank test.
  
  
  RESULTS
  Clinically, no side-effects were observed. In total, 59% of the patients with ocular surface changes improved objectively (slit-lamp examination). Partial or full healing of corneal changes, as well as subjective relief of symptoms, was observed in 16 of 20 patients with keratoconjunctivitis sicca (p < 0.001). The 14 patients with persistent epithelial defect experienced neither objective nor subjective improvements during serum treatment.
  
  
  CONCLUSIONS
  Ready-made ABO-identical allogeneic serum eye drops were straightforwardly produced, quality-assured and registered as a safe standard blood product for the treatment of certain cases of severe dry eye disease. Therapeutic efficacy was comparable to previous reports on autologous serum drops.
authors.affiliation: Department of Clinical Immunology, Blood Bank, Rigshospitalet, Copenhagen, Denmark.
authors.forename: Lene Holm
authors.initials: LH
authors.lastname: Harritshøj
authors.forename: Connie
authors.initials: C
authors.lastname: Nielsen
authors.forename: Henrik
authors.initials: H
authors.lastname: Ullum
authors.forename: Morten Bagge
authors.initials: MB
authors.lastname: Hansen
authors.forename: Hanne Olsen
authors.initials: HO
authors.lastname: Julian
mesh_terms: D000017:ABO Blood-Group System / Q000097:blood*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001771:Blood Banks; D001782:Blood Donors; D058731:Blood Safety; D003317:Corneal Dystrophies, Hereditary / Q000628:therapy*; D019573:Epithelium, Corneal / Q000473:pathology*; D005260:Female; D006801:Humans; D007638:Keratoconjunctivitis Sicca / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000008:administration & dosage*; D044967:Serum; D016896:Treatment Outcome; D014945:Wound Healing; D055815:Young Adult
chemical_list: D000017:ABO Blood-Group System; D009883:Ophthalmic Solutions
keywords: allogeneic serum eye drops; blood bank; severe ocular surface disease; whole-blood donation