Hip-Joint Resurfacing with Functional Human Cartilage

摘要 最近的美国健康统计表明，大约840，000名40-65岁的患者患有 活动限制性髋关节OA，但只有约15%的人选择接受髋关节置换术 手术这一低百分比归因于髋关节植入物的预期寿命缩短， 患者和随后需要翻修手术和整体有效性降低。左 如果没有可行的手术选择，这些年轻，活跃的患者只能通过以下方式来控制他们的疼痛： 药品或营养品。为了满足这一年轻活跃患者群体的需求，Cytex 治疗公司正在开发一种植入物，可以用来取代患病的软骨， 股骨头目的是避免传统的全髋关节置换术，缓解疼痛， 并恢复积极的生活方式，这将解决临床问题， 目前存在。我们在临床前研究中取得了显著进展，并表明我们的 使用仿生支架的方法产生具有类似于 那些天然软骨。我们独特的双层种植体复制了 在空间上控制组织发育，导致植入物立即 恢复功能，同时促进长期组织再生。最终，原生组织重新形成 植入物降解，给病人留下一个活的生物组织替代物。核心 软骨表面置换植入物的技术采用了3D微编织织物粘合到多孔 骨传导基质，以创建一个高性能，精确设计的植入物。植入物可以 制造成与髋关节中发现的复杂几何形状和定制曲率相匹配， 专门设计用于目前软骨修复方案无法治疗的大型关节炎病变。 由于我们已经成功地将我们的技术应用于越来越复杂的体内， 动物模型，我们目前正在寻求投资，以加快这项技术的市场， 同时通过小企业NIH机制寻求后续资金。为此中央 该提案的目的有两个方面：1）解决制造和扩大规模的问题， 技术和建立制造计划，以及2）为我们的植入物制定监管计划 技术.由于制造和监管计划的制定都很重要， 商业化的障碍，我们的目标是利用这个商业化准备试点计划 在完成临床前工作的同时开始解决这些障碍。这些计划的制定 将有利于我们的商业化计划，但也有价值的潜在投资者，因为我们将有 通过完成这些目标，应对了许多重大的监管和制造问题。

Abstract Recent US health statistics indicate that approximately 840,000 patients in the 40-65 age range suffer from activity limiting hip OA, but only about 15% of this group choose to undergo hip replacement surgery. This low percentage is attributed to the shortened projected lifetime of hip implants for active patients and the subsequent need for revision surgeries and overall decreased effectiveness. Left without viable surgical alternatives, these young, active patients are left to manage their pain through pharmaceuticals or nutraceuticals. To address the need of this young active patient population, Cytex Therapeutics, Inc. is developing an implant that can be used to replace the diseased cartilage of the femoral head. The goal is to stave off a traditional total hip arthroplasty procedure, provide pain relief, and restore an active lifestyle, which would solve a clinical problem for which no good solutions currently exist. We have made outstanding progress in our pre-clinical research and showed that our approach using biomimetic scaffolds produce implants with excellent functional properties similar to those of native cartilage. Our unique, bilayered implant replicates the load-bearing properties of the respective tissues and spatially controls tissue development, resulting in an implant that immediately restores function while promoting long-term tissue regeneration. Eventually, the native tissues re-form and the implant degrades, leaving the patient with a living, biologic tissue replacement. The core technology of the cartilage resurfacing implant employees a 3D microwoven textile bonded to a porous osteoconductive substrate to create a high-performance, precisely engineered implant. The implant can be manufactured to match complex geometries and custom curvatures found in the hip joint and is specifically designed for large arthritic lesions that are untreatable with current cartilage repair options. Because of the success we have seen when applying our technology in vivo in increasingly complex animal models, we are currently seeking investments to accelerate this technology to market while simultaneously pursuing follow-on funding through small business NIH mechanisms. To this end, the purpose of this proposal is two-fold: 1) to address manufacturing and scale up issues with our technology and establish a manufacturing plan, and 2) to develop a regulatory plan for our implant technology. As the development of both manufacturing and regulatory plans are significant impediments to commercialization, our goal is to use this Commercialization Readiness Pilot Program to start to address these hurdles while completing our preclinical work. The development of these plans will be beneficial for our commercialization plans but also valuable to potential investors as we will have responded to many significant regulatory and manufacturing issues by the completion of these aims.