Preserving Platelets for storage and transportation using a novel desiccation pro

描述(申请人提供)：尽管血小板是止血的关键成分，但目前的血小板储存方法严重限制了它们作为救命血液的效用。 组件。在迄今为止进行的相关工作中，我们已经开发出在干燥形式下长期保存哺乳动物细胞的方法(&gt；6个月)。这项技术包括细胞特定的脱水和复水缓冲剂，以及真空辅助干燥。已经建立了一种记录红细胞的方案，干燥的红细胞可用于诊断应用的有限数量(血液病生物技术，MD)。我们已经获得了初步数据，表明所开发的干燥过程可以应用于血小板。脱水后的血小板在复水后保持完好，总体大小和功能与过期的血小板相似。此外，当比较经过其他干燥技术(如冷冻干燥)的干燥的血小板时，干燥的血小板显示不会导致血栓形成，具有非常低的微粒含量(这是在输血医学中使用血小板的真正问题)。为了优化血小板的干燥过程，在第一阶段的研究中，我们建议：1)通过改变脱水剂的成分、真空干燥方案，并将样品在室温下以干燥的形式保存长达一个月，在不同条件下对血小板进行干燥。2)在我们的实验室和我们的合作者的实验室中，通过执行测试来评估血小板的物理和生物功能，如大小、激活状态和血栓形成能力，确定干燥的血小板在复水后恢复功能的程度。这一努力的成功将促进用于治疗和诊断试剂的标准化血小板干燥方案的开发，目标是消除丢弃过期血小板(占所有血小板的20%)的需要，这将使美国医疗保健系统每年花费约4-6亿美元。储存干燥的血小板的能力通过简化灾区、战区和偏远人口中心的救命治疗的提供，解决了许多后勤问题。这一阶段的终点是拥有足够强大的保存血小板的过程和协议，以表明长期保存的潜力。我们将建议在第二阶段SBIR项目中进行进一步的研究和开发，以建立长期保存的干燥稳定血小板的方案，用于一般治疗和诊断应用。 与公众健康相关：该项目建议使用细胞特异性试剂和真空辅助干燥过程来保存干燥状态下的血小板，以便长期保存。该项目的成功将把目前血小板的保质期从5-7天延长到几个月，使细胞可用于治疗和诊断目的。

DESCRIPTION (provided by applicant): Although platelets are a critical component in hemostasis, current methods for platelet storage severely limit their utility as a lifesaving blood component. In related work conducted to date, we have developed methods to preserve mammalian cells in desiccated format for extended periods (> 6 months). The technology involves cell specific dehydration and rehydration buffering reagents coupled with vacuum assisted desiccation. A documented protocol for erythrocytes has been established and dried red cells are available in limited quantities for diagnostic applications (Hememics Biotech, MD). We have obtained preliminary data indicating the desiccation process developed can be applied to platelets. The desiccated platelets, upon rehydration, remain intact with overall size and function similar to that of in-dated platelets. Furthermore, when compared dried platelets that had gone through other drying techniques such as lyophilization, the desiccate platelets showed to be non-thrombogenic with very low micropartical content (a real concern for using platelets in transfusion medicine). In order to optimize the platelet desiccation process, in Phase I research, we propose to: 1) Desiccate platelets under various conditions by varying constituents of dehydration reagents, vacuum desiccation protocols, and storing samples in a dried format at room temperature for up to a month . 2) Determine the extent to which desiccated platelets recover functionality upon rehydration by performing tests to assess platelets physical and biological functions such as, size, activation status and thrombogenicity in our lab and the labs of our collaborators. Success in this endeavor will facilitate development of a standardized platelet desiccation protocol for therapeutic and diagnostic reagents with a goal to eliminate the need to discard outdated platelets (20% of all platelets) at a cost of ~ $400-$600 million annually to US health care system. The ability to stockpile dried platelets addresses a number of logistical issues by simplifying the delivery of life saving treatments in disaster areas, war zones and remote population centers. The endpoint of this phase I is to have sufficiently robust processes and protocols for the preservation of platelets to indicate potential for long term storage. We will propose further investigation and development in the Phase II SBIR project to establish protocols for dried stabilized platelets with long term preservation for general therapeutic and diagnostic applications. PUBLIC HEALTH RELEVANCE: The project proposes to use cell specific reagent and a vacuum assisted desiccation process to preserve platelets in dried state for long term preservation. The success of the project will extend the current shelf- life of platelets from 5-7 days to several months, making the cells available for therapeutic and diagnostic purposes.