SIMPLIFIED FROZEN BLOOD METHODOLOGY FOR AUTOLOGOUS BLOOD

说明(调查人员摘要)：此第二阶段项目的目标 是为了确定在25摄氏度下储存的冰冻红细胞 长达6个月的体内存活期将与 冰冻的红细胞在零下65摄氏度下保存长达10年， 并将符合食品和药物管理局制定的标准 血液制品“红血”生物研究与评价办公室 在第一阶段的项目中，甘油化的几种方法 冰冻在零下25摄氏度之前的红细胞被检测并 对这些细胞的解冻方法也进行了评估。初步数据来自 第一阶段表明，超过90%的红细胞回收可以 在零下25摄氏度储存长达三个月后才能实现。这个 第二阶段提案的具体目的是评估红血球的稳定性 用这些方法冷冻保存的细胞超过12个月。红细胞 将评估输血后的存活率和恢复情况 生化特征，包括2/3的DPG和ATP水平来评价 该产品适合输血。这项研究的总体目标是 开发技术以扩大自体献血者的能力 包括使用简化的冷冻方法的方案 在零下25摄氏度保存。这样的商业潜力 发展将是相当可观的，因为缺乏这些机构 用于处理冰冻的精密冷冻和加工设备 要求献血的人可以参加这项活动。可能是世界上 对于这个国家的相关应用将在自体领域 采血。将扩大获得血液冷冻技术的常规途径 收集第一个单元的时间与收集第一个单元的时间 电刀手术。它也可能在欠发达地区得到应用 缺乏先进的冷冻设备来维护稀有食品的国家 血液单位。

DESCRIPTION (Investigator's Abstract): The goal of this Phase II project is to determine whether frozen red cells stored at 25 degrees Celsius for periods up to six months will have an in vivo survival equal to that of frozen red cells stored at -65 degrees Celsius for periods up to ten years, and will meet the criteria established by the Food and Drug Administration Office of Biological Research and Review for the blood product, "red blood cells frozen." During a Phase 1 project, several methods of glycerolizing red blood cells prior to freezing at -25 degrees Celsius were explored and methods of thawing these cells were also evaluated. Preliminary data from Phase 1 suggested that greater than 90 percent of red cell recovery could be achieved after -25 degrees Celsius storage for up to three months. The specific aim of the Phase 2 proposal is to evaluate stability of red blood cells cryopreserved by these methods over a twelve-month period. Red cell survival and recovery after transfusion will be assessed as well as biochemical characteristics, including 2/3 DPG and ATP levels to evaluate the products suitability for transfusion. The overall goal of the study is to develop technology to expand the capabilities of autologous blood donor programs to include the use of a simplified method for freezing preservation at - 25 degrees Celsius. The commercial potential of such a development would be considerable, in that institutions lacking sophisticated freezing and processing equipment for dealing with frozen blood requests could participate in this activity. Probably the most relevant application for this country would be in the area of autologous blood collection. Routine access to blood freezing technology would expand the interval between the time the first unit is collected and the time of the electric surgery. It may also have application in underdeveloped countries lacking sophisticated freezing equipment for maintenance of rare blood units.