Commercialization Readiness for Bone Filler Scaffold Device to Aid in Dental Applications and Reconstruction

骨填充支架装置的商业化准备有助于牙科应用和重建

• 批准号: 10554541
• 负责人: Karrer Alghazali
• 金额: $ 3.97万
• 依托单位: NUSHORES BIOSCIENCES, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-01 至 2023-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10554541
• 关键词: Address; Alveolar Ridge Augmentation; Alveolar ridge; Alveolar wall; Animal Testing; Animals; Architecture; Autologous Transplantation; Automation; Back; Biocompatible Materials; Bone Regeneration; Bone Transplantation; Calvaria; Canis familiaris; Chemicals; Clinic; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Contractor; Contracts; Control Groups; Cyclic GMP; Data; Defect; Dental; Dental Clinics; Dental Implantation; Dental Implants; Development; Devices; Documentation; Filler; Funding; Future; Grant; Human; Hydration status; Implant; In Situ; Industry; Inflammation; Investments; Life; Mandible; Maxillary Sinus; Medical; Medical Device; Membrane; Modeling; Molds; Monitor; Morbidity - disease rate; National Institute of Dental and Craniofacial Research; Operative Surgical Procedures; Oryctolagus cuniculus; Osseointegration; Osteogenesis; Patient Recruitments; Patients; Performance; Positioning Attribute; Price; Procedures; Process; Production; Property; Protocols documentation; Quarantine; Readiness; Reconstructive Surgical Procedures; Regulation; Rehabilitation therapy; Reporting; Research; Research Contracts; Research Design; Research Personnel; Risk Assessment; Safety; Secure; Shapes; Sinus; Small Business Innovation Research Grant; Surgeon; Techniques; Technology; Testing; Time; Translating; Universities; Writing; base; biomaterial compatibility; bone; commercialization; cost; craniomaxillofacial; design; experience; first-in-human; good laboratory practice; healing; improved; instrument; meetings; neovascularization; novel; pre-clinical; preclinical study; preservation; reconstruction; sample fixation; scaffold; substantia spongiosa; success; trial readiness; virtual

Project Summary Current bone grafting techniques for functional rehabilitation with dental implants have limitations – high-cost, difficulties with fixation and stabilization, insufficient bone regeneration, high morbidity using autogenous block grafts and prolonged healing of up to 9 months. Existing synthetic bone fillers cannot match defect shape and volume, are weakly resorbed if at all, are not easily and quickly modifiable in size and shape during surgery, cannot promote early and enhanced neovascularization and osseointegration; and are poorly suited for advanced reconstruction. Current technologies cannot be modulated to match existing bone architecture – a critical feature for improved healing. Although pre-implant reconstructive surgeries are commonly performed, an estimated 7% of patients are unable to receive dental implants due to these limitations. The NuCress™ scaffold has shown in animal studies that it is a better alternative for these autografts, due to its controllable shape and form, enhanced bone formation and early neovascularization, shelf-life stability and tolerance over a range of storage conditions, and a composition that includes only components that have received FDA clearance for use in other devices or are in process of clearance. In situ, the scaffold swells to lock into place in the bone defect, eliminating the need for special instruments to secure it. These scaffolds could reduce costs and convalescent time, benefiting millions of patients. NIDCR-funded Fast Track SBIR results demonstrate superior and fast bone regeneration by the NuCressTM bone filler scaffold for craniomaxillofacial applications in pre-clinical animal studies, setting the stage for the next step of commercialization to benefit patients. Integral to commercialization is FDA approval for the NuCressTM scaffold as a dental medical device (required) and clinical trials (highly desirable). These essential steps require implementing and finalizing manufacturing practices to meet FDA manufacturing regulations (Aim 1), performing biocompatibility and chemical characterization/risk assessment studies, as well as animal studies per FDA guidance to compare performance of the NuCressTM scaffold to a predicate device and untreated control group in critical-sized alveolar ridge defect model (Aim 2), transition from production for research to production for patient treatment in clinics (Aim 3), and planning and preparing for clinical trials in the future (Aim 4). The proposed team has the expertise and experience backed by academic and clinical leaders, globally recognized Contract Research Organizations, and consultants successfully fulling FDA studies and NIDCR-supported clinical study successes.

项目摘要 当前用于牙齿牙齿功能康复的骨移植技术有局限性 - 高成本，固定和稳定难度，骨骼再生不足，发病率高 使用自动块移植物和长时间的愈合长达9个月。现有的合成骨 填充剂无法匹配缺陷形状和音量，如果根本不容易被弱化，并且 手术期间的大小和形状可以快速修改，无法提早促进和增强 新血管形成和骨整合；并且非常适合高级重建。 当前技术不能调制以匹配现有的骨骼体系结构 - 关键功能 尽管如此，通常进行了植入前的重建手术，但 由于这些限制，估计有7％的患者无法接受牙齿。这 Nucress™支架在动物研究中表明，它是这些自体移植的更好替代方法， 由于其受控形状和形式，增强的骨形成和早期的新血管形成， 保质期稳定性和在一系列存储条件下的耐受性，以及一个组成 仅包括已在其他设备中使用FDA清关的组件或 原位，脚手架隆起锁定在骨骼缺陷中，消除 需要特殊仪器来保护它。这些脚手架可以降低成本， 康复时间，使数百万患者受益。 NIDCR资助的快速轨道SBIR结果 通过NucressTM骨填充脚手架表现出优质和快速的骨再生 颅颌面应用在临床前动物研究中，为下一步奠定了阶段 商业化以使患者受益。商业化不可或缺的是FDA的批准 NucressTM支架作为牙科医疗装置（必需）和临床试验（非常可取）。 这些基本步骤需要实施和完成制造实践才能满足FDA 制造法规（AIM 1），进行生物相容性和化学表征/风险 评估研究以及每项FDA指导的动物研究，以比较 Nucresstm支架到关键大小的肺泡中的谓词装置和未处理的对照组 山脊缺陷模型（AIM 2），从生产的研究到患者生产的过渡 诊所的治疗（AIM 3）以及将来的临床试验计划和准备（AIM 4）。 拟议中的团队具有学术和临床领导者支持的专业知识和经验， 全球认可的合同研究组织和顾问成功地装满FDA 研究和NIDCR支持的临床研究成功。