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: 10684346
• 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: 2018
• 资助国家: 美国
• 起止时间: 2018-09-22 至 2023-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10684346
• 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 目前用于牙种植体功能康复的骨移植技术具有局限性 - 成本高，固定和稳定困难，骨再生不足，发病率高 使用自体块状移植物和长达9个月的延长愈合。现有合成骨 填充物不能匹配缺损的形状和体积，如果有的话，被弱吸收，不容易， 在手术过程中可快速改变大小和形状，不能促进早期和增强 新血管形成和骨整合;并且不适合于晚期重建。 目前的技术无法调整以匹配现有的骨结构-这是一个关键特征 以改善愈合。尽管通常进行植入前重建手术， 估计有7%的患者由于这些限制而无法接受牙科植入物。的 NuCress™支架在动物研究中显示，它是这些自体移植物的更好替代品， 由于其可控的形状和形式，增强的骨形成和早期的新血管形成， 在一定范围的储存条件下的贮存期稳定性和耐受性，以及一种组合物， 仅包括已获得FDA批准用于其他器械或 清除过程。在原位，支架膨胀以锁定在骨缺损中的适当位置， 需要特殊的工具来固定它。这些支架可以降低成本， 康复时间，惠及数百万患者。NIDCR资助的Fast Track SBIR结果 通过NuCressTM骨填充物支架展示了上级和快速的骨再生， 临床前动物研究中的颅颌面应用，为下一步奠定基础 商业化，让患者受益。商业化不可或缺的是FDA批准的 NuCressTM支架作为牙科医疗器械（必需）和临床试验（非常可取）。 这些基本步骤要求实施并最终确定生产实践，以满足FDA 制造法规（目标1），执行生物相容性和化学表征/风险 评估研究，以及根据FDA指南进行的动物研究，以比较 NuCressTM支架与同品种器械和未处理对照组在临界尺寸肺泡 脊状缺损模型（目标2），从研究生产过渡到患者生产 临床治疗（目标3），以及规划和准备未来的临床试验（目标4）。的 建议的团队拥有学术和临床领导者支持的专业知识和经验， 全球公认的合同研究组织和顾问成功地完成了FDA 研究和NIDCR支持的临床研究成功。