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Infusion of P-Capt prion-filtered red blood cell products demonstrate acceptable in vivo viability and no evidence of neoantigen formation

Authors

  • Jose A. Cancelas,

    Corresponding author
    1. From the Hoxworth Blood Center, University of Cincinnati, Cincinnati, Ohio; The Alpha Bio Group, New Canaan, Connecticut; and the Department of Pathology, University of Michigan, Ann Arbor, Michigan.
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  • Neeta Rugg,

    1. From the Hoxworth Blood Center, University of Cincinnati, Cincinnati, Ohio; The Alpha Bio Group, New Canaan, Connecticut; and the Department of Pathology, University of Michigan, Ann Arbor, Michigan.
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  • P. Gayle Pratt,

    1. From the Hoxworth Blood Center, University of Cincinnati, Cincinnati, Ohio; The Alpha Bio Group, New Canaan, Connecticut; and the Department of Pathology, University of Michigan, Ann Arbor, Michigan.
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  • D. Nicole Worsham,

    1. From the Hoxworth Blood Center, University of Cincinnati, Cincinnati, Ohio; The Alpha Bio Group, New Canaan, Connecticut; and the Department of Pathology, University of Michigan, Ann Arbor, Michigan.
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  • Joan C. Pehta,

    1. From the Hoxworth Blood Center, University of Cincinnati, Cincinnati, Ohio; The Alpha Bio Group, New Canaan, Connecticut; and the Department of Pathology, University of Michigan, Ann Arbor, Michigan.
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  • Kate Banks,

    1. From the Hoxworth Blood Center, University of Cincinnati, Cincinnati, Ohio; The Alpha Bio Group, New Canaan, Connecticut; and the Department of Pathology, University of Michigan, Ann Arbor, Michigan.
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  • Robertson D. Davenport,

    1. From the Hoxworth Blood Center, University of Cincinnati, Cincinnati, Ohio; The Alpha Bio Group, New Canaan, Connecticut; and the Department of Pathology, University of Michigan, Ann Arbor, Michigan.
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  • W. John Judd

    1. From the Hoxworth Blood Center, University of Cincinnati, Cincinnati, Ohio; The Alpha Bio Group, New Canaan, Connecticut; and the Department of Pathology, University of Michigan, Ann Arbor, Michigan.
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Jose A. Cancelas, MD, PhD, Hoxworth Blood Center, Research Division, University of Cincinnati, 3130 Highland Avenue, Cincinnati, OH 45267-0055; e-mail: jose.cancelas@uc.edu.

Abstract

BACKGROUND: Transmission of variant Creutzfeldt-Jacob disease (vCJD) is a major concern in blood transfusion. The P-Capt filter has been shown to remove around 4 log ID50 prion infectivity from prion-spiked human red blood cells (RBCs).

STUDY DESIGN AND METHODS: Two independent, single-center, randomized, open-label studies were designed to analyze the safety of P-Capt–filtered RBCs. RBCs prepared from leukoreduced whole blood from 43 eligible subjects were randomly assigned to P-Capt filtration and/or storage in plasma or SAGM and stored for 28 or 42 days. Stored RBCs were analyzed for in vivo 24-hour recovery, hemolysis, metabolic variables, blood group antigen expression, neoantigen formation, and safety after autologous infusion.

RESULTS: Mean P-Capt filtration times for leukoreduced RBCs were 41 (SAGM) to 51 (plasma) minutes. Thirteen of 14 subjects receiving P-Capt–filtered RBCs had 24-hour RBC recoveries of 75% or more after 42-day storage, with a mean hemolysis of less than 0.6%. No loss of RBC antigen expression or formation of neoantigens was observed. In both studies, RBCs had white blood cell counts of less than 1 × 106/unit after leukofiltration. P-Capt prion filtration provided an additional greater than 0.8 log leukoreduction. No serious or unexpected adverse events were observed after infusion of P-Capt–filtered full-volume RBC units.

CONCLUSIONS: P-Capt–filtered, stored RBCs demonstrated acceptable viability and no detectable neoantigen expression, immunogenic responses. or safety issues after infusion of a complete unit. The additional filtration time and modest reduction in RBC content are within acceptable levels for implementation in countries with transfusion transmission of vCJD.

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