Red blood cells derived from whole blood treated with riboflavin and ultraviolet light maintain adequate survival in vivo after 21 days of storage

• Published in: Transfusion (Philadelphia, Pa.) Pa.), 2017-05, Vol.57 (5), p.1218-1225
• Main Authors: Cancelas, Jose A., Slichter, Sherrill J., Rugg, Neeta, Pratt, P. Gayle, Nestheide, Shawnagay, Corson, Jill, Pellham, Esther, Huntington, Marty, Goodrich, Raymond P.
• Format: Article
• Language: English
• Subjects: Adult; Blood; Blood Preservation - methods; Blood Safety; Cell Survival - drug effects; Cell Survival - radiation effects; Cross-Over Studies; Disinfection - methods; Erythrocytes - cytology; Erythrocytes - drug effects; Erythrocytes - radiation effects; Female; Hemolysis; Humans; Male; Prospective Studies; Riboflavin - pharmacology; Single-Blind Method; Ultraviolet Rays
• ISSN: 0041-1132; 1537-2995
• DOI: 10.1111/trf.14084

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 51Cr/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