Reshapable Hydrogel Tissue Expander

描述（由申请人提供）：对于牙科和其他应用，非常需要能够在植入时由外科医生重塑以适应空隙的自填充组织扩张器。Akina最近完成了一项初步的II期研究，使用其基于水凝胶的可重塑肿胀组织扩张器（Restiex（R））。该研究验证了Restiex生成大鼠皮肤和犬粘膜额外组织的功能。我们随后的犬研究表明，在犬中成功形成新组织所需的Restiex特性与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成功插入、扩张和取出扩张器所需的Restiex特性的重要信息。该延续II期研究旨在合成具有犬研究中确定的三种关键特性的水凝胶。控制膨胀动力学和膨胀压力对于防止引起膨胀器坏死和喷发的缺血是至关重要的。控制机械强度对于在扩张结束时容易地将扩张器整体移除是必要的。具有定制特性的新型水凝胶组织扩张器将在我们的狗模型中进行安全性和有效性测试。Barco，本研究的共同研究者。在第二阶段更新研究结束时，我们将拥有Restiex扩张器的最终配方，可用于临床测试和商业化。该II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）在口内犬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Akina能够充分开发其基于水凝胶的Restiex，该产品与目前市售的组织扩张器相比具有显著优势。没有现有的组织扩张器允许外科医生进行整形，并且还允许受控的膨胀动力学和扩张压力。凭借这些优势，Akina的Restiex有望立即对该领域产生影响。在第二阶段更新项目结束时，Akina将能够生产出安全有效的新型组织扩张器，为人体临床试验做好准备。

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.