Improving Pancreas/Islets Preservation HTS/CryoStor

改善胰腺/胰岛保存 HTS/CryoStor

• 批准号: 7196318
• 负责人: Robert G Van Buskirk
• 金额: $ 56.45万
• 依托单位: CELL PRESERVATION SERVICES, INC.
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-20 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7196318
• 关键词: cryopreservation; histology; human tissue; ischemia; molecular biology; oxidative stress; pancreas; pancreatic islets; reperfusion; technology /technique development; temperature; tissue /organ preservation

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.

项目概述/摘要：Cell Preservation Services Inc. （CPSI）计划开发几种新产品，用于改善离体胰岛的低温储存和冷冻保存，用于治疗1型糖尿病。CPSI及其制造合作伙伴BioLife Solutions Inc.已经开发出2万无蛋白保存溶液平台，目前已用于fda批准的细胞治疗程序。应用范围从细胞心肌成形术到保存原代人肝细胞。低温溶胶（HTS）平台专为低温储存（4C）而设计；而CryoStor系列o是为低温保存（-196(C)）配制的。本一期项目致力于开发一系列连接的胰岛保存产品，即HTS-Islets、HTSRxCUE-Islets、CryoStor-Islets和CPRxCUE-Islets，旨在对低温储存和低温保存的离体人类胰岛进行最佳保存和恢复/救援。二期研究将致力于开发一套类似的连接低温溶液，hts -胰腺和htsrxcue -胰腺，为更好地保存整个人类胰腺而配制。这个1/2期项目的总体意图和独特之处在于开发6种串联保存解决方案，这将改善人类胰岛的恢复、分离和储存——这是一个尚未用于任何细胞治疗应用的序列过程。具体目标是：(1)识别和调节人类胰岛因保存而激活的应激通路；(2)胰岛保存全胰腺2层法变异检测；(3)利用有关缺血和再灌注的文献，为低温储存或低温保存后的胰岛加热至常温后的胰岛开发恢复或救援方案。这些新的保存解决方案将有助于通过改善全胰腺保存来增加胰岛的可用性，并提高目前用于1型糖尿病细胞治疗应用的分离胰岛的活力和功能。项目简介：美国的几家细胞治疗和组织工程公司现在正在向世界各地运送他们的活体产品。Cell Preservation Services Inc.是一家独特的公司，专门从事开发解决方案，以维持这些产品处于“假死状态”，直到它们到达临床和非临床目的地。这笔拨款旨在开发4种相关的保存解决方案，以改善分离的人类胰岛的运输和储存，从而促进用于1型糖尿病细胞治疗的人类胰岛的时间管理。