Proceedings of the Food and Drug Administration public workshop on pathogen reduction technologies for blood safety 2018 (Commentary, p. 3026)

Atreya, Chintamani; Glynn, Simone; Busch, Michael; Kleinman, Steve; Snyder, Edward; Rutter, Sara; AuBuchon, James; Flegel, Willy; Reeve, David; Devine, Dana; Cohn, Claudia; Custer, Brian; Goodrich, Raymond; Benjamin, Richard J.; Razatos, Anna; Cancelas, Jose; Wagner, Stephen; Maclean, Michelle; Gelderman, Monique; Cap, Andrew; Ness, Paul

After completion of the AIMS clinical trial, the Japan International Cooperation Agency partnered with the Terumo Corporation of Japan and the AABB Consulting Services to support sustainable blood safety in Ghana with routine use of the Mirasol WB system in conjunction with the creation of the infrastructure for a hemovigilance system. 150 The partnership expanded the use of Mirasol PRT for WB within Ghana; established an active hemovigilance system at two teaching hospitals, Komfo Anokye Teaching Hospital in Kumasi and Korle-bu Teaching Hospital in Accra; and provided the necessary training and support. In September of 2018, Japan International Cooperation Agency successfully handed over the Ghana Blood Safety Program to the Ministry of Health (MOH). 150 Dr. Aaron Tobian with the Makerere University-Johns Hopkins University (MU-JHU) Collaboration will expand use of the Mirasol PRT system for WB in Africa to Uganda with the Mirasol Evaluation of Reduction in Infections Trial (MERIT). 141 The primary objective was to evaluate the Mirasol WB system to reduce malaria and other TTIs in Uganda. 150 Secondary objectives include an evaluation of the impact of TTI and potential benefit of PRT as well as the feasibility and sustainability of implementing Mirasol in austere environments. 141 In addition to Mirasol PRT treatment of WB for transfusion, active studies are under way to evaluate componentization of Mirasol-treated WB. Terumo BCT has initiated the PRAISE clinical trial to evaluate efficacy and safety of RBCs derived from Mirasol-treated WB compared to conventional RBCs in patients requiring chronic transfusion support. 151 Moreover, Terumo BCT has supported investigator-initiated studies of components derived from Mirasol-treated WB. One such study conducted by Dr. Pavel Trakhtman from the Russian Federal Center for Pediatric Hematology, Oncology and Immunology evaluated the safety and efficacy of RBCs derived from Mirasol-treated WB in pediatric patients with malignancies. 152 Finally, as part of Terumo BCT's commitment to advancing blood safety, the company is investing in innovation to further refine and improve PRT.