HTS-TEETH-A new preservation solution for avulsed teeth

描述(由申请人提供)：细胞保存服务公司(CPSI)开发生物包装的新技术，用于人体细胞和组织的低温保存(40至80摄氏度)和低温保存(-196摄氏度)。HypoThermosol(HTS)平台包括HTS-PURGE、HTS-BASE、HTS-DCC、HTS-FRS、HTS-AIE和GelStor，以及再生医学市场客户正在使用的其他定制解决方案。该公司的无血清CryoStor冷冻保存解决方案平台专为在液氮中存储细胞和组织而设计，需要降低DMSO水平。CPSI的解决方案是围绕细胞死亡级联的分子事件而设计的，由于延长了保存时间，可以启动这些级联。一旦知道，溶液配方就会改变，从而抑制这些细胞死亡过程。几种HTS变种已经被证明比目前的商业解决方案(例如Viaspan)有明显的好处。HTS和CryoStor解决方案现在是FDA批准的几种细胞治疗IND的组件。再生医学领域的这一成功现在提供了CPSI在其业务计划中最初没有预见到的临床应用机会。CPSI发现，商业上唯一可用于短期保存撕脱牙齿的解决方案是Save-A-Tooth，这是Hanks Balance Salt Solution(HBSS)的一个品牌名称。HBSS从来没有被设计成一种有效的低温储存溶液，并被CPSI用作其阴性对照。考虑到HTS在室温下的稳定性，以及CPSI利用其多分辨率和竞争应力途径假说开发细胞匹配保存溶液的能力，CPSI决定开发一种HTS变体HTS-Teats，该变体将专门用于短期保存撕脱的牙齿。这五个特定目标(SA)如下：SA1-测试当前HTS变体关于保存牙周膜(PDL)细胞作为HTS-Team的候选基础溶液；分析细胞质凋亡途径(SA2)和基因组应激和凋亡途径(SA3)作为冷藏PDL细胞的结果；SA4-使用基于SA2和3的数据确定的调节器修改SA1 HTS变体；SA5-比较SA1-SA4中开发的HTS牙齿作为从NIH获得的PDL干细胞的保存溶液。第二阶段将致力于进行更全面的cdna微阵列工作，分析细胞功能，并在体内测试HTS牙齿。

DESCRIPTION (provided by applicant): Cell Preservation Services Inc (CPSI) develops new technologies in Biological Packaging for hypothermic storage (40 to 80 C) and cryopreservation (-196C) of human cells and tissues. The HypoThermosol (HTS) platform consists of HTS-PURGE, HTS-BASE, HTS-DCC, HTS-FRS, HTS-AIE and GelStor as well as other custom solutions being utilized by clients in the Regenerative Medicine market. The Company's serum-free CryoStor cryopreservation solution platform is designed for cell and tissue storage in liquid nitrogen and requires reduced DMSO levels. CPSI's solutions are designed around the molecular events underlying cell death cascades that can be launched due to extended preservation storage. Once known, solution formulation is altered in such a manner that inhibits these cell death processes. Several HTS variants have been shown to have a marked benefit over present commercial solutions (e.g.Viaspan). HTS and CryoStor solutions are now components of several FDA-approved INDs in cell therapy. This success in Regenerative Medicine has now provided clinical application opportunities that were not originally envisioned by CPSI in its business plan. CPSI has discovered that the only solution commercially available for the short-term storage of avulsed teeth is Save-A-Tooth, a brand name for Hanks Balanced Salt Solution (HBSS). HBSS was never designed to be an effective hypothermic storage solution and is used by CPSI as its negative control. Given HTS's stability at room temperature and the ability of CPSI to develop cell-matched preservation solutions using its Multisolution and Competitive Stress Pathway hypotheses, CPSI has decided to develop an HTS variant, HTS-TEETH, that will be expressly developed for the short term storage of avulsed teeth. The five Specific Aims (SA) are the following: SA1-Test current HTS variants on the preservation of periodontal ligament (PDL) cells as candidate base solutions for HTS-TEETH; Analyze the cytoplasmic apoptosis pathways (SA2) and genomic stress and apoptosis pathways (SA3) activated as a consequence of chill storage of PDL cells; SA4-Modify the SA1 HTS variant with modulators identified based on data from SA2,3; SA5- Compare HTS-TEETH developed in SA1-SA4 as a preservation solution for PDL stem cells procured from NIH. Phase 2 will be dedicated to performing more comprehensive cDNA microarray work, analyzing cell function and testing HTS-TEETH in vivo.