title: Red blood cells derived from whole blood treated with riboflavin and ultraviolet light maintain adequate survival in vivo after 21 days of storage.
abstract: BACKGROUND
  Pathogen reduction (PR) of whole blood (WB) may increase blood safety when applied before component separation. This study evaluates the in vivo performance of red blood cells (RBCs) derived from WB treated with the riboflavin and ultraviolet (UV) light PR (Mirasol) system.
  
  
  METHODS
  This was a prospective, two-center, single-blind, randomized, two-period, crossover clinical trial designed to evaluate autologous51Cr/99mTc-radiolabeled recovery and survival of RBCs derived from Mirasol-treated WB compared to untreated WB. RBCs were stored in AS-3 for 21 days at 1 to 6°C. In vitro RBC variables were characterized. Frequency and severity of treatment-emergent adverse event (TEAE) and neoantigenicity were determined.
  
  
  RESULTS
  Twenty-four healthy adult volunteers (n = 12 per site) were evaluated. The Mirasol 24-hr RBC recoveries were 82.5 ± 3.9% with one-sided 95% lower confidence limit of 80.9%, meeting US Food and Drug Administration acceptance criteria, albeit at lower level than controls (91.7 ± 6.8%, p < 0.001). Mean RBC survival and T50were reduced in the Mirasol group (61 and 23 days, respectively) versus controls (82 and 36 days, respectively; p < 0.001) with a mean area under the curve survival of treated RBCs of 83% of untreated controls. End-of-storage hemolysis in the Mirasol group was 0.22 ± 0.1% (control, 0.15 ± 0.1%; p < 0.001). No neoantigenicity or differences in TEAEs were found.
  
  
  CONCLUSIONS
  RBCs derived from Mirasol WB and stored for up to 21 days in AS-3 maintained acceptable cell quality and recovery, albeit modestly reduced compared with untreated RBCs. Mirasol WB may represent a valid single WB PR platform that allows manufacture of RBC for storage for up to 21 days.
authors.affiliation: Hoxworth Blood Center, University of Cincinnati, Cincinnati, Ohio.
authors.forename: Jose A
authors.initials: JA
authors.lastname: Cancelas
authors.affiliation: Bloodworks Northwest, Seattle, Washington.|University of Washington, Seattle, Washington.
authors.forename: Sherrill J
authors.initials: SJ
authors.lastname: Slichter
authors.affiliation: Hoxworth Blood Center, University of Cincinnati, Cincinnati, Ohio.
authors.forename: Neeta
authors.initials: N
authors.lastname: Rugg
authors.affiliation: Hoxworth Blood Center, University of Cincinnati, Cincinnati, Ohio.
authors.forename: P Gayle
authors.initials: PG
authors.lastname: Pratt
authors.affiliation: Hoxworth Blood Center, University of Cincinnati, Cincinnati, Ohio.
authors.forename: Shawnagay
authors.initials: S
authors.lastname: Nestheide
authors.affiliation: Bloodworks Northwest, Seattle, Washington.
authors.forename: Jill
authors.initials: J
authors.lastname: Corson
authors.affiliation: Bloodworks Northwest, Seattle, Washington.
authors.forename: Esther
authors.initials: E
authors.lastname: Pellham
authors.affiliation: Terumo BCT, Lakewood, Colorado.
authors.forename: Marty
authors.initials: M
authors.lastname: Huntington
authors.affiliation: Infectious Disease Research Center, Colorado State University, Fort Collins, Colorado.
authors.forename: Raymond P
authors.initials: RP
authors.lastname: Goodrich
mesh_terms: D000328:Adult; D001769:Blood; D001793:Blood Preservation / Q000379:methods*; D058731:Blood Safety; D002470:Cell Survival / Q000187:drug effects / Q000528:radiation effects; D018592:Cross-Over Studies; D004203:Disinfection / Q000379:methods*; D004912:Erythrocytes / Q000166:cytology* / Q000187:drug effects / Q000528:radiation effects; D005260:Female; D006461:Hemolysis; D006801:Humans; D008297:Male; D011446:Prospective Studies; D012256:Riboflavin / Q000494:pharmacology*; D016037:Single-Blind Method; D014466:Ultraviolet Rays
chemical_list: D012256:Riboflavin