Anaerobically stored red blood cells with extended shelf-life.

描述(申请人提供)：该项目的长期目标是开发一种新型的储血袋，可以延长添加剂系统红细胞单元的保质期，同时提供更高效率的红细胞用于输血治疗。在这个系统中，红细胞储存在缺氧条件下的改良添加剂溶液中。最终产品将具有更长的保质期(12周或更长时间)，以及比传统方法储存的相同年龄的血液更高的功效(更多的活细胞，更高的输血后立即氧气输送能力，以及更多的变形细胞，以更好地进行毛细血管灌流)。新的储存系统将很容易适应目前的血库运作，而不会引起程序或设备的重大改变。在这项第一阶段的提案中，将测试一种新型的厌氧储存系统，该系统在储存6周后，与传统方法(AS-1添加剂系统)相比，其保质期延长50%(至9周)，并产生具有更高输注后回收率的红细胞的能力。在交叉临床试验(8名志愿者)中，收集一个单位的红细胞，并在厌氧条件下将其储存在实验添加剂溶液(测试)或常规方法(对照)中。一小部分储存的细胞将被标记并回输给捐赠者，通过测量输血后24小时的恢复和长期存活来评估储存细胞的质量。这些测量将在存储6周后进行，以评估拟议的系统是否比对照组具有更高的恢复率。9周后，测试单位还将对它们进行测量，以评估其将保质期延长50%的能力。保存的红细胞具有较高的输血后活性和氧气输送能力，将提高输血治疗的疗效，减少相关副作用。此外，在需要长期输血的受试者(如镰状细胞病或β-地中海贫血)中，输注这种红细胞将减少频率和时间平均输血量和总的铁负荷。延长保质期将改善普通血库的物流，缓解周期性的血液短缺，并提高术前自体血液采集的效用。

DESCRIPTION (provided by applicant): The long-term objective of this project is to develop a novel blood storage bag that will extend the shelf life of additive system red cell units, and at the same time, deliver red cells of higher efficacy for transfusion therapy. In this system, red cells are stored in a modified additive solution under oxygen- depleted conditions. The final product will have extended shelf-life (12 weeks or more) as well as higher efficacy compared to same-aged blood stored by conventional methods (more viable cells, higher oxygen delivery capacity immediately after transfusion and more deformable cells for better capillary perfusion). The new storage system will be readily accommodated by the current blood banking operation without incurring major alteration in procedures or equipments. In this Phase I proposal, a novel anaerobic storage system will be tested for its ability to extend shelf life by 50%(to 9 weeks) and to yield red cells with higher post-transfusion recovery compared to the conventional method (AS-1 additive system) after 6 weeks of storage. In a cross over clinical trial (8 volunteers), a unit of red cells will be collected and stored under anaerobic condition in an experimental additive solution (test) or in a conventional method (control). A small fraction of stored cells will be labeled and transfused back to the donor to assess the quality of the stored cells by measuring the 24 hr post- transfusion recovery and long-term survival. These measurements will be taken after 6 weeks of storage to assess whether the proposed system has higher recovery compared to the control. They will be also measured after 9 weeks for the test units to assess its ability to extend shelf life by 50%. Stored red cells with higher post-transfusion viability and oxygen delivery capacity will improve the efficacy of transfusion therapy and reduce associated side effects. Moreover, transfusion of such red cells will reduce the frequency- and time-averaged blood transfusion volume and total iron burden in subjects who require chronic transfusion (e.g., sickle cell disease or beta-thalassemia). Extended shelf-life will improve the logistics of general blood banking, alleviate the periodic blood shortages and enhance the utility of pre-operative autologous blood collection.