ArticleTransfusion2026
Safety and tolerability of amustaline/glutathione pathogen-reduced red blood cells in neonatal rats.
Article in Transfusion, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundAmustaline (S-303)/glutathione (GSH) pathogen-reduced red blood cells (PR-RBCs) are in development for all adult and pediatric RBC transfusion indications, including neonates and infants. A neonatal rat model evaluated the safety and tolerability of PR-RBCs during growth and maturation. STUDY DESIGN AND
methodsRepeated transfusions of 10 mL/kg syngeneic untreated (control) RBCs, PR-treated (study) or "high-degradant" PR-RBCs were transfused three-times weekly to neonatal Sprague-Dawley rats from post-natal day (PND) 4 through adolescence (PND 64). The high-degradant PR-RBCs utilized amustaline concentrations 5-fold higher than in the clinical process, without a terminal wash step. Toxicokinetic characteristics of the major amustaline degradant (S-300) were determined on PNDs 15, 29 and at study termination. Animal well-being, weight, sexual maturation, and cognitive development (using the Morris water maze) were monitored. On PND 65-68 terminal necropsy and pathological analyses were performed.
resultsAll recipient groups demonstrated normal and comparable weight gain, sexual maturation, and cognitive development. There were no PR-RBC-related effects on clinical signs, clinical chemistry, gross- or histopathology, although all rats had polycythemia (Hb 16.6-17.0 g/dL) with reduced reticulocytes (0.6-1.4%) at study end. S-300 was cleared rapidly (<60 min in the study group) and did not accumulate in the blood. The high-degradant PR-RBC group, with 6.2-fold reduced species-specific scaling for increased basal metabolic rate, were exposed to ~11.8-fold higher S-300 exposure than expected in repeatedly-transfused patients, without apparent adverse effects.
conclusionThe neonatal rat study demonstrates the safety and tolerability of amustaline/GSH PR-RBCs for transfusion and supports clinical use in pediatric patients.
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