Efficacy of apheresis platelets treated with riboflavin and ultraviolet light for pathogen reduction

BACKGROUND: Pathogen reduction technologies for platelet (PLT) components offer a means to address continued viral transmission risks and imperfect bacterial detection systems. The efficacy of apheresis PLTs treated with riboflavin (vitamin B2) plus ultraviolet (UV) light (Mirasol, Navigant Biotechnologies) was investigated in a single-blind, crossover study in comparison to untreated PLTs. STUDY DESIGN AND METHODS: Normal subjects (n = 24) donated PLTs by apheresis on two occasions at least 2 weeks apart. Units were randomized to control or test arms, the latter receiving the addition of 28 mL of 500 mu mol per L B2 and exposure to 6.2 J per mL UV light. PLTs were stored for 5 days with biochemical and hematologic analyses performed before and after illumination on Day 0 and at the end of storage. An aliquot of each unit was radiolabeled and returned to determine recovery and survival. RESULTS: The PLT content of treated units was maintained from Day 0 (4.1 x 10(11) +/- 0.4 x 10(11)) to Day 5 (4.0 x 10(11) +/- 0.4 x 10(11)). Treatment with B2 plus UV light was associated with an increase in lactate production with concomitant increases in glucose consumption. pH (control, 7.38 +/- 0.07; test, 7.02 +/- 0.10) was well maintained throughout storage. Recovery of treated PLTs (50.0 +/- 18.9%) was reduced from that of control PLTs (66.5 +/- 13.4%); survival was similarly shortened (104 +/- 26 hr vs. 142 +/- 26 h; p < 0.001). CONCLUSIONS: PLTs treated with B2 plus UV light demonstrate some alterations in in vitro measures but retain in vitro and in vivo capabilities similar to pathogen-reduced and licensed PLT components that have been shown to have useful clinical applicability. The recovery, survival, and metabolic properties of Mirasol PLTs should provide sufficient hemostatic support in thrombocytopenia to justify patient clinical trials.