Reshapable Hydrogel Tissue Expander

描述(申请人提供)：对于牙科和其他应用，非常需要能够由外科医生在植入时重塑以填补空隙的自充式组织扩张器。Aina公司最近使用其基于水凝胶的可重塑肿胀组织扩张器(Restiex(R))完成了初步的第二阶段研究。这项研究证实了Restiex在大鼠皮肤和狗粘膜中产生额外组织的功能。我们随后的狗研究表明，在狗身上成功形成新组织所必需的Rstiex特性与从大鼠研究中确定的特性非常不同。重要的是，我们目前的研究提供了有关成功插入、扩张和移除扩张器所需的Restiex属性的重要信息。这项持续的第二阶段研究旨在合成具有三种关键性质的水凝胶，这些特性是从狗的研究中确定的。控制膨胀动力学和膨胀压力是防止缺血引起的扩张和坏死的关键。控制机械强度是必要的，以便于在膨胀结束时将膨胀机整体移除。这项研究的合作者之一Clark T.Barco博士将在我们的狗模型中测试具有定制特性的新型水凝胶组织扩张器的安全性和有效性。在这项第二阶段更新研究结束时，我们将为临床测试和商业化准备好Restiex膨胀剂的最终配方。这一二期更新项目有三个具体目标：(1)合成具有可控膨胀动力学、扩张压力和机械强度的可重塑组织扩张器；(2)在犬口腔内模型中验证组织扩张器的安全性和有效性；(3)建立体外扩张器性能与体内性能之间的相关性。更新后的第二阶段项目将使Aina能够充分开发其基于水凝胶的Restiex，该产品比目前商业上可获得的组织扩张器具有重大优势。现有的组织扩张器不允许外科医生重塑，也允许受控的膨胀动力学和扩张压力。凭借这些优势，Aina的Restiex预计将对该领域产生立竿见影的影响。在这一更新第二阶段项目结束时，Aina将能够生产安全有效的新型组织扩张器，准备用于人体临床试验。

DESCRIPTION (provided by applicant): For dental and other applications there is a great need for self-filling tissue expanders with the capacity to be reshaped to fit the void by the surgeon at time of implantation. Akina recently completed an initial Phase II study using its hydrogel-based reshapable swelling tissue expanders (Restiex(R)). The study validated the function of Restiex to generate additional tissue of rat skin as well as of dog mucosa. Our subsequent dog study indicated that the properties of Restiex necessary for successful new tissue formation in dogs were very different from the properties identified from the rat study. Importantly, our current study has provided vital information on the Restiex properties required for successful insertion, expansion, and removal of the expander. This continuation Phase II study is to synthesize hydrogels possessing three critical properties identified from the dog studies. Controlling the swelling kinetics and expansion pressure is essential in preventing ischemia which causes necrosis and eruption of the expander. Controlling the mechanical strength is necessary for easy removal of the expander in one piece at the end of the expansion. The new hydrogel tissue expanders with tailor-made properties will be tested in our dog model for safety and effectiveness by Dr. Clark T. Barco, a co-investigator of this study. At the end of this Phase II renewal study, we will have the final formulation of Restiex expanders ready for clinical testing and commercialization. There are three specific aims of this Phase II renewal project: (1) to synthesize reshapable tissue expanders with controllable swelling kinetics, expansion pressure, and mechanical strength; (2) to validate safety and efficacy of tissue expanders in the intraoral dog model; and (3) to establish correlation between in vitro expander properties and in vivo performances. The renewed Phase II project will allow Akina to fully develop its hydrogel-based Restiex that has substantial advantages over current commercially available tissue expanders. No existing tissue expanders allow reshaping by a surgeon and also allow for the controlled swelling kinetics and expansion pressure. With these advantages, Akina's Restiex is expected to have immediate impact to the field. At the end of this renewal Phase II project, Akina will be able to produce safe and effective novel tissue expanders that are ready for human clinical trials.