A Resorbable Cryoprobe Provides a Salvage Therapeutic Option

描述（由申请人提供）：细胞保存服务公司（CPSI）是一家生物技术公司，专注于开发新的和创新的方法，使用冷却和冷冻温度来支持细胞治疗和癌症领域。在前者中，CPSI研究低温储存（4C）和低温保存（-196）期间激活的应激途径，以便制定改进的保存方案。这些解决方案由CPSI的营销合作伙伴BioLife solutions Inc.销售，用于fda批准的细胞治疗IND 's。这些关于应激途径的相同数据也被用于在消融冷冻过程中促进癌细胞的细胞死亡——这是一种将传统冷冻手术与辅助治疗（如5-FU、顺铂）相结合的疗法。这种方法最近引发了一项由医生赞助的用于治疗晚期前列腺癌的IND。本一期项目拟开发一种新型治疗性冷冻手术设备（CryoInject, tm），用于治疗复发性前列腺癌。开发该系统的原因如下：(1)CryoInject（tm）将是一种手持设备，便于应用；(2)将结合CryoPellet（tm）技术（冷冻低剂量化疗颗粒）应用于病变区域的特定部位；(3)应用的最初目的是作为治疗前列腺癌的救助性治疗工具；(4)该装置的使用也可能是一种有效的神经保护手术。第一阶段的具体目标是：SA1 -确定哪种冷剂最适合“CryoPellet（tm）”设计；SA2 -确定“CryoPellet（tm）”的有效性和可行性；SA3 -低温注射系统原型设计SA4 -在冷冻手术中检测CryoPellet（tm）和CryoInjectTM系统的效果。I期和2期的成功完成将导致CryoInject（tm）系统的发展，该系统可作为前列腺癌的替代和有效的挽救性治疗选择。一旦开发和测试，该系统可能会成为前列腺癌的替代治疗方法，以及治疗肾癌和肝癌的替代方法。因此，这种新颖的治疗设计将为临床领域提供重大益处，并为未来开发用于治疗癌症的微创治疗方案提供平台。本项目旨在研究和开发一种治疗前列腺癌的新型治疗装置（CryoInjectTM和CryoPelletTM）。该设备将用于施加冷冻温度（冷冻消融）来破坏不需要的组织。

DESCRIPTION (provided by applicant): Cell Preservation Services Inc. (CPSI) is a biotechnology corporation focused on developing new and innovative approaches to the use of chilling and freezing temperatures in support of the cell therapy and cancer arenas. In the former, CPSI studies stress pathways activated during hypothermic storage (4C) and cryopreservation (-196) so that improved preservation solutions can be formulated. These solutions, sold by CPSI's marketing partner BioLife Solutions Inc., are used in FDA-approved cell therapy IND'S. These same data on stress pathways are also being used to potentiate cell death in cancer cells during ablative freezing processes - a regime that couples traditional cryosurgery with adjuvant (e.g. 5-FU, cisplatin) treatments. This approach has recently led to the initiation of a physician sponsored IND for the treatment of advanced stage prostate cancer. This Phase I project proposes to develop a novel therapeutic cryosurgical device (CryoInject(tm)) for treating recurrent prostate cancer. The reasoning behind the development of the system are as follows: (1) The CryoInject(tm) will be a hand held device allowing for ease of application; (2) It will incorporate the CryoPellet(tm) technology (frozen low dose chemotherapeutic pellets) applied in specific locations of the diseased area; (3) The application of will initially be intended as a salvage therapy tool for treating prostate cancer and; (4) the utilization of this device may also be an effective nerve-sparing procedure. The Specific Aims of the Phase 1 are: SA1 - Identify which cryogen is best suited for "CryoPellet(tm)" design; SA2 - Determine the efficacy and feasibility of the "CryoPellet(tm)"; SA3 - Design a prototype CryoInjectTM System; SA4 - Test the efficacy of the CryoPellet(tm) and CryoInjectTM System during cryosurgery. Successful completion of Phase I and 2 will lead to the development of the CryoInject(tm) system which can then be used as an alternative and effective salvage treatment option for prostate cancer. Once developed and tested, the system may become useful as an alternative treatment for prostate cancer as well as an alternative method for treating renal and liver cancers. Consequently, this novel therapeutic design will provide a major benefit to the clinical area as well as provide a platform for future development of minimally invasive therapeutic regimes for the treatment of cancer. The intent of this project is to investigate and develop a novel therapeutic device (CryoInjectTM and CryoPelletTM) for treating prostate cancer. The device will be used to apply freezing temperatures (cryoablation) to destroy unwanted tissue.