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）开发用于人体细胞和组织低温储存（40至80℃）和低温保存（-196℃）的生物包装新技术。低温溶胶（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使用的其他定制解决方案。该公司的无血清CryoStor冷冻保存溶液平台专为细胞和组织在液氮中储存而设计，需要降低DMSO水平。CPSI的解决方案是围绕潜在的细胞死亡级联的分子事件设计的，这些事件可以由于延长的保存存储而启动。一旦知道，溶液配方就会改变，从而抑制这些细胞死亡过程。一些HTS变体已被证明比目前的商业解决方案（例如viaspan）具有明显的优势。HTS和CryoStor解决方案现在是fda批准的几个细胞治疗ind的组成部分。再生医学的成功现在提供了CPSI在其商业计划中最初没有设想到的临床应用机会。CPSI发现，商业上唯一可以短期储存撕脱牙齿的解决方案是Save-A-Tooth，汉克斯平衡盐溶液（HBSS）的品牌名称。HBSS从未被设计成有效的低温储存溶液，并被CPSI用作阴性对照。考虑到HTS在室温下的稳定性，以及CPSI利用其多溶液和竞争应激途径假设开发细胞匹配保存溶液的能力，CPSI决定开发HTS变体HTS- teeth，该变体将专门用于短期保存撕脱牙。五个特定目标（SA）是：sa1 -测试当前HTS变体对保存牙周韧带（PDL）细胞的作用，作为HTS- teeth的候选基础溶液；分析低温贮藏后PDL细胞胞质凋亡通路（SA2）和基因组应激及凋亡通路（SA3）的激活情况；sa4 -使用基于SA2、3的数据确定的调制器修改SA1 HTS变体；SA5-比较在美国国立卫生研究院（NIH）采购的PDL干细胞保存液SA1-SA4中培养的HTS-TEETH。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-TEETH。

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.