Cryopreservation of Engineered Tissue Equivalents

工程组织等效物的冷冻保存

• 批准号: 9014592
• 负责人: LIA H CAMPBELL
• 金额: $ 62.02万
• 依托单位: TISSUE TESTING TECHNOLOGIES, LLC
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-16 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9014592
• 关键词: Cryopreservation; Engineered; Tissue; Equivalents

DESCRIPTION (provided by applicant): In an effort to reduce the use of animals for toxicity testing, companies have developed in vitro skin models or equivalents to replace the Draize skin irritation test. This development has been further pushed by the European Union regulation that has prohibited the use of animals for collecting toxicological data on cosmetic ingredients that began 2009. Supply of these engineered tissues skin equivalents is a significant issue that can be solved by development of effective cryopreservation methods. Presently, these constructs are made to order and require a lead time of several weeks before they can be used. A cryopreserved product would be available when needed eliminating lead time required to manufacture the product. Additionally, performance of quality control checks for stock that is ready to be shipped could be performed and large batches could be manufactured providing a cost savings to suppliers. A cryopreserved skin model would also provide the end- user greater flexibility for scheduling of experiments without concern regarding availability of the constructs and it would be possible to order from the same batch of product in order to have better control of uniformity within research studies. In Phase I, our alternate strategy, vitrification was used t successfully cryopreserve the skin construct Epiderm with a viability of 91%. Three specific aims are proposed for Phase II. The vitrification protocol will be optimized for epithelial tissue constructs in well inserts to include not only Epiderm but other epithelial tissue constructs relevant to toxicity testing. In addition, experiments are planned to scale up the vitrification process for larger numbers of samples and determine optimum storage and shipping conditions. This optimized process would also be applicable to other tissue engineered tissue constructs, such as cardiovascular tissue equivalents.

描述（由申请人提供）：为了减少使用动物进行毒性测试，公司开发了体外皮肤模型或等效模型来取代 Draize 皮肤刺激测试。欧盟法规进一步推动了这一发展，该法规从 2009 年开始禁止使用动物来收集化妆品成分的毒理学数据。这些工程组织皮肤等同物的供应是一个重大问题，可以通过开发有效的冷冻保存方法来解决。目前，这些结构是按订单生产的，需要几周的交货时间才能使用。需要时可以使用低温保存的产品，从而消除制造产品所需的交货时间。此外，可以对准备发货的库存进行质量控制检查，并且可以进行大批量生产，从而为供应商节省成本。冷冻保存的皮肤模型还可以为最终用户提供更大的实验安排灵活性，而无需担心构建体的可用性，并且可以从同一批产品中订购，以便更好地控制研究中的均匀性。在第一阶段，我们的替代策略是使用玻璃化冷冻技术成功冷冻保存皮肤构建体 Epiderm，其活力为 91%。为第二阶段提出了三个具体目标。玻璃化方案将针对孔插入物中的上皮组织构建体进行优化，不仅包括表皮，还包括与毒性测试相关的其他上皮组织构建体。此外，还计划进行实验以扩大玻璃化过程以处理更多样品，并确定最佳储存和运输条件。这种优化的过程也适用于其他组织工程组织构建体，例如心血管组织等同物。