A Resorbable Cryoprobe Provides a Salvage Therapeutic Option

可吸收冷冻探针提供挽救治疗选择

• 批准号: 7272283
• 负责人: Kristi K Snyder
• 金额: $ 16.86万
• 依托单位: CELL PRESERVATION SERVICES, INC.
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-27 至 2009-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7272283
• 关键词: Ablation; Address; Adjuvant; Affect; Anatomy; Animals; Apoptosis; Area; Biological Preservation; Biopsy; Biotechnology; Bladder; Blood Vessels; Carbon Dioxide; Cardiology; Cell Death; Cell Survival; Cell Therapy; Cells; Cervical dysplasia; Chills; Cisplatin; Clinical; Companions; Computer Systems Development; Coupled; Couples; Cryopreservation; Cryosurgery; Cytotoxic agent; Data; Dermatology; Development; Devices; Disease; Dose; Effectiveness; Ensure; Exposure to; Fluorouracil; Freezing; Future; Gel; General Hospitals; Growth; Gynecology; Hand; Hour; Human; Ice; Incidence; Incontinence; Industry; Injection of therapeutic agent; Invasive; Kidney; Lead; Liquid substance; Location; Malignant Neoplasms; Malignant neoplasm of liver; Malignant neoplasm of prostate; Marketing; Medical; Methods; Modeling; Molecular; Monitor; Morbidity - disease rate; Mus; Necrosis; Needles; Nerve; Nitrogen; Operative Surgical Procedures; Pathway interactions; Patients; Pattern; Phase; Physicians; Physics; Placement; Procedures; Process; Prostate; Prostate Adenocarcinoma; Prostate Cancer therapy; Prostatic Neoplasms; Protocols documentation; Purpose; Range; Recovery; Recurrence; Rupture; Salvage Therapy; Services; Solid; Solutions; Staging; Stress; Structure; Study models; Supporting Cell; Surface; System; Technology; Temperature; Testing; Therapeutic; Time; Tissue Engineering; Tissues; Treatment Protocols; Ultrasonography; Urethra; Urology; anticancer research; aqueous; base; cancer cell; cancer therapy; cell killing; cellular engineering; cold temperature; compare effectiveness; concept; day; design; desire; improved; innovation; novel; novel therapeutics; prototype; rectal; response; sensor; size; success; thermal stress; three-dimensional modeling; tool; tumor

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.

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，专注于开发新的创新方法，利用低温和冷冻温度来支持细胞治疗和癌症领域。在前者中，CPSI研究在低温储存(4C)和低温保存(-196)期间激活的应激通路，从而可以配制出改进的保存液。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。这些关于应激途径的数据也被用于增强消融性冷冻过程中癌细胞的细胞死亡-这是一种将传统冷冻手术与辅助(例如5-FU、顺铂)治疗相结合的疗法。这种方法最近导致了医生赞助的IND治疗晚期前列腺癌的启动。这个第一阶段的项目建议开发一种用于治疗复发性前列腺癌的新型治疗性冷冻外科设备(CryoInject(Tm))。开发该系统背后的理由如下：(1)CryoInject(Tm)将是一种便于使用的手持设备；(2)它将采用CryoPellet(Tm)技术(冷冻低剂量化疗药丸)，应用于疾病区域的特定位置；(3)CryoInject(Tm)的应用最初将被用作治疗前列腺癌的挽救治疗工具；(4)该设备的使用也可能是一种有效的神经保护程序。第一阶段的具体目标是：SA1-确定哪种制冷剂最适合“CryoPellet(Tm)”设计；SA2-确定“CryoPellet(Tm)”的有效性和可行性；SA3-设计一个原型CryoInjectTM系统；SA4-在冷冻外科期间测试CryoPellet(Tm)和CryoInjectTM系统的有效性。第一阶段和第二阶段的成功完成将导致CryoInject(Tm)系统的开发，该系统随后可用作前列腺癌的一种替代和有效的挽救治疗选择。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，这种新的治疗设计将为临床领域提供重大好处，并为未来开发用于癌症治疗的微创治疗方案提供平台。本项目的目的是研究和开发一种治疗前列腺癌的新型治疗装置(CryoInjectTM和CryoPelletTM)。该设备将用于应用冷冻温度(冷冻消融)来破坏不需要的组织。