Improving Pancreas/Islets Preservation HTS/CryoStor

描述(由申请人提供)：项目摘要/摘要：细胞保存服务公司(CPSI)计划开发几种新产品，用于改善分离的人胰岛的低温存储和冷冻保存，用于治疗1型糖尿病。CPSI及其制造合作伙伴BioLife Solutions Inc.已经开发了2个不含蛋白质的保存溶液平台，目前正用于FDA批准的细胞治疗程序。应用范围从细胞性心肌成形术到原代人类肝细胞的保存。HypoThermosol(HTS)平台是为低温存储(4C)设计的；而CryoStor系列o是为低温保存(-196(C))而设计的。该项目的第一阶段致力于开发一系列相连的胰岛保存产品，称为HTS-Islets、HTSRxCUE-Islets、CryoStor-Islets和CPRxCUE-Islets，旨在最佳地保存和恢复/拯救低温存储和冷冻保存的孤立人胰岛。第二阶段的研究将致力于开发一套类似的相互关联的低温解决方案，HTS-胰腺和HTSRxCUE-胰腺，用于改善整个人类胰腺的保存。这一阶段1/2计划的总体意图和独特功能是开发6种相互关联的保存方案，以便串联使用，从而改善人类胰岛的恢复、分离和存储-这是一种尚未用于任何细胞治疗应用的顺序过程。其具体目标是：(1)识别和调节人类胰岛保存后激活的应激通路；(2)测试全胰腺2层法保存胰岛的变体；(3)利用有关缺血和再灌注的文献，为低温保存或低温保存后升温到常温的胰岛开发恢复或救援解决方案。这些新的保存解决方案将通过改进整个胰腺的保存来帮助增加胰岛的可用性，并改善目前用于治疗1型糖尿病的细胞治疗应用中的孤立胰岛的生存能力和功能。项目简介：美国的几家细胞治疗和组织工程公司现在正将他们的生活产品运往世界各地。细胞保存服务公司是一家专门开发解决方案的公司，该公司专门开发解决方案，以便在这些产品到达临床和非临床目的地之前，将其保持在“暂停状态”。这笔赠款旨在开发4种相互关联的保存解决方案，以改善孤立的人类胰岛的运输和存储，从而促进用于细胞疗法的人类胰岛的时间管理，以治疗1型糖尿病。

DESCRIPTION (provided by applicant): Project Summary/Abstract: Cell Preservation Services Inc. (CPSI) plans to develop several new products for the improved hypothermic storage and cryopreservation of isolated human pancreatic islets to be used for treating Type 1 diabetes. CPSI and its manufacturing partner, BioLife Solutions Inc., have developed 2, protein-free, preservation solution platforms now being used in FDA-approved cell therapy procedures. Applications range from cellular cardiomyoplasty to the preservation of primary human hepatocytes. The HypoThermosol (HTS) platform is designed for hypothermic storage (4C); whereas the CryoStor series o is formulated for cryopreservation (-196(C). This Phase I project is devoted to developing a series of linked islets preservation products referred to as HTS-Islets, HTSRxCUE-Islets, CryoStor-Islets, and CPRxCUE-Islets designed for the optimal preservation and recovery/rescue of hypothermically stored and cryopreserved isolated human islets. Phase 2 studies will be dedicated to developing a similar set of linked hypothermic solutions, HTS-Pancreas and HTSRxCUE-Pancreas, formulated for the improved preservation of whole human pancreas. The overall intention and unique feature of this Phase 1/2 program is the development of 6 linked preservation solutions to be used in tandem which will result in improved human islets recovery, isolation and storage-a sequence process that has yet to be used for any cell therapy application. The specific aims are: (1) Identifying and modulating the stress pathways activated in human islets as a consequence of preservation; (2) Testing variants of the whole pancreas 2 layer method for islets preservation; and (3) Leveraging the literature on ischemia and reperfusion to develop recovery or rescue solutions for islets that are warmed to normothermic temperatures subsequent to hypothermic storage or cryopreservation. These new preservation solutions will help increase the availability of islets through improved whole pancreas preservation as well as improve the viability and function of isolated islets currently used in cell therapy applications to treat Type 1 diabetes. Project Narrative: Several cell therapy and tissue engineering companies in the United States are now shipping their living products worldwide. Cell Preservation Services Inc. is a unique company that specializes in developing solutions for the purpose of maintaining these products in a "state of suspended animation" until such time that they arrive at their clinical and non-clinical destinations. This grant is designed to develop 4 linked preservation solutions that will improve the shipping and storage of isolated human islets and thus will facilitate the time management of human islets used for cell therapy to treat Type 1 diabetes.