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. STUDY DESIGN AND METHODS: This was a prospective, two-center, single-blind, randomized, two-period, crossover clinical trial designed to evaluate autologous 51 Cr/99m Tc-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 T50 were 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. CONCLUSION: 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.
RCT Entities:
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. STUDY DESIGN AND METHODS: This was a prospective, two-center, single-blind, randomized, two-period, crossover clinical trial designed to evaluate autologous 51 Cr/99m Tc-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 T50 were 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. CONCLUSION: 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: Michał Bubiński; Agnieszka Gronowska; Paweł Szykuła; Agnieszka Woźniak; Aleksandra Rodacka; Scott Santi; Marcia Cardoso; Elżbieta Lachert Journal: Blood Transfus Date: 2022-02-01 Impact factor: 5.752
Authors: Americo Cicchetti; Silvia Coretti; Francesco Sacco; Paolo Rebulla; Alessandra Fiore; Filippo Rumi; Rossella Di Bidino; Luz I Urbina; Pietro Refolo; Dario Sacchini; Antonio G Spagnolo; Emanuela Midolo; Giuseppe Marano; Blandina Farina; Ilaria Pati; Eva Veropalumbo; Simonetta Pupella; Giancarlo M Liumbruno Journal: Blood Transfus Date: 2018-09-03 Impact factor: 3.443
Authors: Lina Y Dimberg; Suzann K Doane; Susan Yonemura; Heather L Reddy; Nick Hovenga; E Jane Gosney; Melissa Tran; Shilo Wilkinson; Raymond P Goodrich; Susanne Marschner Journal: Transfus Med Hemother Date: 2019-02-22 Impact factor: 3.747
Authors: Chintamani Atreya; Simone Glynn; Michael Busch; Steve Kleinman; Edward Snyder; Sara Rutter; James AuBuchon; Willy Flegel; David Reeve; Dana Devine; Claudia Cohn; Brian Custer; Raymond Goodrich; Richard J Benjamin; Anna Razatos; Jose Cancelas; Stephen Wagner; Michelle Maclean; Monique Gelderman; Andrew Cap; Paul Ness Journal: Transfusion Date: 2019-05-29 Impact factor: 3.157
Authors: Ronnie Kasirye; Heather A Hume; Evan M Bloch; Irene Lubega; Dorothy Kyeyune; Ruchee Shrestha; Henry Ddungu; Hellen Wambongo Musana; Aggrey Dhabangi; Joseph Ouma; Priscilla Eroju; Telsa de Lange; Michael Tartakovsky; Jodie L White; Ceasar Kakura; Mary Glenn Fowler; Philippa Musoke; Monica Nolan; M Kate Grabowski; Lawrence H Moulton; Susan L Stramer; Denise Whitby; Peter A Zimmerman; Deo Wabwire; Isaac Kajja; Jeffrey McCullough; Raymond Goodrich; Thomas C Quinn; Robert Cortes; Paul M Ness; Aaron A R Tobian Journal: Trials Date: 2022-04-04 Impact factor: 2.279