Cancelas Jose A, Slichter Sherrill J, Rugg Neeta, Pratt P Gayle, Nestheide Shawnagay, Corson Jill, Pellham Esther, Huntington Marty, Goodrich Raymond P
Hoxworth Blood Center, University of Cincinnati, Cincinnati, Ohio.
Bloodworks Northwest, Seattle, Washington.
Transfusion. 2017 May;57(5):1218-1225. doi: 10.1111/trf.14084. Epub 2017 Mar 31.
Pathogen reduction (PR) of whole blood (WB) may increase blood safety when applied before component separation. This study evaluates the in vivo performance of red blood cells (RBCs) derived from WB treated with the riboflavin and ultraviolet (UV) light PR (Mirasol) system.
This was a prospective, two-center, single-blind, randomized, two-period, crossover clinical trial designed to evaluate autologous Cr/ Tc-radiolabeled recovery and survival of RBCs derived from Mirasol-treated WB compared to untreated WB. RBCs were stored in AS-3 for 21 days at 1 to 6°C. In vitro RBC variables were characterized. Frequency and severity of treatment-emergent adverse event (TEAE) and neoantigenicity were determined.
Twenty-four healthy adult volunteers (n = 12 per site) were evaluated. The Mirasol 24-hr RBC recoveries were 82.5 ± 3.9% with one-sided 95% lower confidence limit of 80.9%, meeting US Food and Drug Administration acceptance criteria, albeit at lower level than controls (91.7 ± 6.8%, p < 0.001). Mean RBC survival and T were reduced in the Mirasol group (61 and 23 days, respectively) versus controls (82 and 36 days, respectively; p < 0.001) with a mean area under the curve survival of treated RBCs of 83% of untreated controls. End-of-storage hemolysis in the Mirasol group was 0.22 ± 0.1% (control, 0.15 ± 0.1%; p < 0.001). No neoantigenicity or differences in TEAEs were found.
RBCs derived from Mirasol WB and stored for up to 21 days in AS-3 maintained acceptable cell quality and recovery, albeit modestly reduced compared with untreated RBCs. Mirasol WB may represent a valid single WB PR platform that allows manufacture of RBC for storage for up to 21 days.
在进行成分分离前对全血（WB）进行病原体灭活（PR）可提高血液安全性。本研究评估了经核黄素和紫外线（UV）光病原体灭活（Mirasol）系统处理的全血来源的红细胞（RBC）的体内性能。
这是一项前瞻性、双中心、单盲、随机、两阶段、交叉临床试验，旨在评估与未处理的全血相比，经Mirasol处理的全血来源的自体铬/锝放射性标记红细胞的回收率和存活率。红细胞在1至6°C下于AS-3中储存21天。对体外红细胞变量进行了表征。确定了治疗中出现的不良事件（TEAE）的频率和严重程度以及新抗原性。
对24名健康成年志愿者（每个研究点12名）进行了评估。Mirasol处理后24小时红细胞回收率为82.5±3.9%，单侧95%置信下限为80.9%，符合美国食品药品监督管理局的验收标准，尽管低于对照组（91.7±6.8%，p<0.001）。与对照组（分别为82天和36天；p<0.001）相比，Mirasol组的红细胞平均存活时间和T缩短，处理后的红细胞曲线下平均存活面积为未处理对照组的83%。Mirasol组储存期末溶血率为0.22±0.1%（对照组为0.15±0.1%；p<0.001）。未发现新抗原性或TEAE存在差异。
经Mirasol处理全血来源的红细胞在AS-3中储存长达21天，尽管与未处理的红细胞相比有所降低，但仍保持了可接受的细胞质量和回收率。Mirasol全血可能代表了一个有效的单一全血病原体灭活平台，可用于制备可储存长达21天的红细胞。
