PFI:AIR - TT: Scale-up and Prototyping of Novel Scaffold Fabrication for Bone Regeneration

PFI:AIR - TT：用于骨再生的新型支架制造的放大和原型制作

• 批准号: 2002879
• 负责人: Mei Wei
• 金额: $ 13.41万
• 依托单位: Ohio University
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-01 至 2022-03-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2002879&HistoricalAwards=false
• 关键词: PFI; AIR; TT; Scale; up

This PFI: AIR Technology Translation project focuses on translating a biomimetic collagen-based bone grafting scaffold for enhanced bone defect repair and new bone regeneration. Currently, more than 1.3 million bone-repair procedures are performed annually in the USA, and a large proportion of them are for large defect repair. The project will result in a prototype of the scaffold production as well as initiation of the FDA documentation process of the biomimetic scaffold. The biomimetic scaffold will directly address the problems of most currently existing bone grafting materials on the market, including poor osteoconductivity, poor mechanical properties, and dissimilar degradation rates to natural bone regenerating rates. It has demonstrated enhanced bone forming capability when compared to a leading product in this market space. The new bone substitute material will greatly benefit patients who suffer from bone defects caused by accidents or diseases, and are in need of orthopedic surgery. Commercialization of this product will greatly improve quality of life for patients, shorten rehabilitation time, and substantially lower medical costs associated with hospitalization and health care.The biomimetic scaffold has the following unique features which make it a competitive product in the bone grafting market: (1) Tunable micro- and macro-structure suitable for enhanced vascularization, osteoprogenitor cells migration, and new bone formation; (2) Mild fabrication conditions (room temperature and neutral pH) and simple fabrication process, which makes the scale-up manufacturing step easy to achieve at a low cost; (3) Superior mechanical properties, providing the necessary mechanical strength for initial surgical handling and mechanical support prior to new bone formation; (4) Excellent osteoconductivity compared to both a commonly used equiaxed scaffold and a commercial scaffold, which will significantly reduce patients' rehabilitation time; (5) Degradation rate matching the ingrowth rate of new bone, leading to perfect defect repair by natural bone that is superior to any artificial bone substitute materials on the market.This project addresses the following technology gaps as it translates from research discovery toward commercial application. It will center on issues related to the biomimetic scaffold scale-up and prototype, such as inhomogeneity and irreproducibility of large pieces of scaffold. To address these problems, heat flow analyses will be conducted and a tight control system will be established, which will further advance understanding of the interrelationship between scaffold structure/property and processing parameters in scaffold scale-up and prototyping. The project will be led by a materials scientist, guided by two entrepreneurs for commercialization, and advised by an orthopedic surgeon to provide the team the end-user perspective. In addition, it will result in the training of a number of graduate and undergraduate students in areas of biomaterial scale-up, product prototyping, FDA documentation and product commercialization, while exposing them to a multidisciplinary working environment.

该PFI：空气技术翻译项目的重点是翻译仿生胶原蛋白的骨移植支架，以增强骨缺损修复和新的骨再生。 目前，每年在美国进行超过130万次骨修复程序，其中很大一部分用于大型缺陷修复。 该项目将导致脚手架生产的原型以及仿生支架的FDA文档过程的启动。 仿生支架将直接解决市场上当前现有的骨移植物材料的问题，包括较差的骨电导率，机械性能差以及对天然骨再生率的降解率不同。 与该市场领域的领先产品相比，它显示出增强的骨骼形成能力。新的骨替代物质将极大地使患有事故或疾病引起的骨骼缺陷的患者有益，并且需要骨科手术。 该产品的商业化将大大改善患者的生活质量，缩短康复时间以及与住院和医疗保健相关的医疗成本大大降低。仿生型脚手架具有以下独特功能，使其成为骨移植市场中的竞争性产品：（1）可调的微型和宏观结构，适合于增强的血管化，Osteapeportor Cellation Cellation，Opteporentor Cells，以及新的骨骼，以及新的骨骼，以及新的形式，以及新的形式，新的形式; （2）轻度制造条件（室温和中性pH）和简单的制造工艺，这使得缩放制造业易于以低成本的速度实现； （3）优质的机械性能，为初始手术处理和机械支撑提供了必要的机械强度，并在新骨形成之前提供了机械强度； （4）与常用的屈脚架和商业支架相比，优异的骨电导率相比，这将大大减少患者的康复时间； （5）与新骨的向内生长速率相匹配的降解率，从而使天然骨骼的完美缺陷修复，这比市场上任何人造骨骼替代材料都优于。该项目解决了以下技术差距，因为它将研究发现转化为商业应用。它将集中在与仿生脚手架尺度和原型相关的问题上，例如大块脚手架的不均匀性和不可补充性。为了解决这些问题，将进行热流分析并建立紧密的控制系统，这将进一步提高对脚手架结构/属性和处理参数之间的相互关系的理解。该项目将由一位材料科学家领导，由两名企业家进行商业化的指导，并由骨科外科医生建议为团队提供最终用户的观点。此外，这将导致培训许多研究生和本科生在生物材料规模，产品原型，FDA文档和产品商业化领域的培训，同时将其暴露于多学科的工作环境中。