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Anaerobically stored red blood cells with extended shelf-life.

厌氧储存的红细胞可延长保质期。

基本信息

批准号：
7272589
负责人：
Tatsuro Yoshida
金额：
$ 13.33万
依托单位：
NEW HEALTH SCIENCES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-06-06 至 2008-08-05
项目状态：
已结题

项目摘要

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.

描述（由申请人提供）：本项目的长期目标是开发一种新型血液储存袋，该袋将延长添加系统红细胞单位的有效期，同时为输血治疗提供更高效的红细胞。在该系统中，红细胞在缺氧条件下储存在改良的添加剂溶液中。与通过常规方法储存的相同年龄的血液相比，最终产品将具有延长的保质期（12周或更长时间）以及更高的功效（更多的活细胞，输血后即刻更高的氧气输送能力和更多的可变形细胞，用于更好的毛细血管灌注）。新的储存系统将很容易被现有的血库运作所容纳，而不会导致程序或设备的重大改变。在本I期提案中，将测试一种新型厌氧储存系统在储存6周后将有效期延长50%（至9周）并产生比传统方法（AS-1添加剂系统）更高的输血后回收率的红细胞的能力。在交叉临床试验（8名志愿者）中，将采集1单位红细胞，并在厌氧条件下储存在实验添加剂溶液（试验）或常规方法（对照）中。将一小部分储存的细胞标记并输回供体，以通过测量输注后24小时的恢复和长期存活率来评估储存细胞的质量。这些测量将在储存6周后进行，以评估与对照相比，拟议系统是否具有更高的回收率。9周后，还将对试验装置进行测量，以评估其将有效期延长50%的能力。储存的红细胞具有更高的输血后活力和氧气输送能力，将提高输血治疗的疗效，减少相关的副作用。此外，这种红细胞的输注将减少需要慢性输注的受试者（例如，镰状细胞病或β-地中海贫血）。延长保质期将改善一般血库的后勤工作，缓解周期性血液短缺，提高术前自体血液采集的效用。