Hoxworth Blood Center, University of Cincinnati, Cincinnati, Ohio 45267-0055, USA.
Transfusion. 2011 Nov;51(11):2367-76. doi: 10.1111/j.1537-2995.2011.03163.x. Epub 2011 May 13.
Transfusion-transmitted infections and immunologic effects of viable residual lymphocytes remain a concern in red blood cell (RBC) transfusion. Pathogen reduction technologies for RBC components are under development to further improve transfusion safety. S-303 is a frangible anchor-linker-effector with labile alkylating activity and a robust pathogen reduction profile. This study characterized the viability of RBCs prepared with a second-generation S-303 process and stored for 35 days.
This was a two-center, single-blind randomized, controlled, crossover study in 27 healthy subjects. S-303 (test) or control RBCs were prepared in random sequence and stored for 35 days, at which time an aliquot of radiolabeled RBCs was transfused. The 24-hour recovery, RBC life span, and in vitro metabolic and viability variables were analyzed.
The mean 24-hour RBC recovery and hemolysis of test RBCs were similar to control RBCs and were consistent with the Food and Drug Administration (FDA) guidance for RBC viability. The mean differences in life span and median life span (T(50) ) of circulating test RBCs were 13.7 and 6.8 days, while the mean difference in the area under the curve of surviving RBCs was 1.38%, in favor of control RBCs. There were no clinically relevant abnormal laboratory values after the infusion of test RBCs. All crossmatch assays of autologous S-303 RBCs were nonreactive.
RBCs prepared using the S-303 pathogen inactivation process were physiologically and metabolically suitable for transfusion after 35 days of storage, met the FDA guidance criteria for 24-hour recovery, and did not induce antibody formation.
输血传播感染和活剩余淋巴细胞的免疫效应仍然是红细胞（RBC）输血关注的问题。正在开发用于 RBC 成分的病原体减少技术，以进一步提高输血安全性。S-303 是一种易碎的锚定连接子效应物，具有不稳定的烷化活性和强大的病原体减少特性。本研究对第二代 S-303 工艺制备并储存 35 天的 RBC 活力进行了特征描述。
这是一项在 27 名健康受试者中进行的双中心、单盲、随机、对照、交叉研究。以随机顺序制备 S-303（测试）或对照 RBC 并储存 35 天，此时输注放射性标记的 RBC 等分试样。分析了 24 小时恢复、RBC 寿命以及体外代谢和活力变量。
测试 RBC 的平均 24 小时 RBC 恢复和溶血与对照 RBC 相似，符合 FDA 对 RBC 活力的指导意见。循环测试 RBC 寿命和中位数寿命（T（50））的平均差异分别为 13.7 和 6.8 天，而存活 RBC 的曲线下面积的平均差异为 1.38%，有利于对照 RBC。输注测试 RBC 后，没有临床相关的异常实验室值。自体 S-303 RBC 的所有交叉配血试验均无反应。
使用 S-303 病原体灭活工艺制备的 RBC 在储存 35 天后在生理和代谢上适合输血，符合 FDA 关于 24 小时恢复的指导标准，并且不会诱导抗体形成。
