I-Corps: A Novel Injectable Bone Healing Gel Device

I-Corps：一种新型可注射骨愈合凝胶装置

• 批准号: 2040076
• 负责人: Dong-Shik Kim
• 金额: $ 5万
• 依托单位: University of Toledo
• 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: 2020-08-15 至 2022-09-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2040076&HistoricalAwards=false
• 关键词: Corps; Novel; Injectable; Bone; Healing

The broader impact/commercial potential of this I-Corps project is to define the requirements for the development of natural polysaccharide (sugar)-based gel devices for bone healing. There has been a recent, sharp increase in the number of orthopedic surgeries worldwide; This is due to the increased aging population with orthopedic diseases and the rising incidence of road accidents. In addition, the increased number of obesity and osteoporosis patients are accompanied with high incidence of bone fracture. Currently available treatments including autografts, allografts, bone graft substitutes (BGSs), and bone morphogenetic proteins (BMPs) suffer from many drawbacks. The proposed gel consists of a natural polysaccharide that as been shown to promote rapid bone growth through osteoconductive and vascularizing effects. In addition, an associated anti-bacterial property is considered an important advantage as more than 70% of patients with fractures in distal extremities suffer from infection that requires treatment. The translation of the proposed gel device is expected to help the patients recover faster without infection. In addition, the treatment may be more cost-effective than the BGSs and BMPs available in the market. The global market is estimated to be the $3.25 billion for treating fractures in distal extremities.This I-Corps project is based on the translation of developments for natural polysaccharide gel devices for bone healing. The device consists of gellan gum and FDA-approved components that demonstrate strong osteoconductive and angiogenetic activities for rapid bone healing with anti-bacterial effects. The current treatments for bone defects are autografts, allografts, bone graft substitutes (BGSs), and bone morphogenetic protein-2 (BMP-2). These methods often suffer from problems such as immuno-rejection, disease transmission, weak bone-forming potency, abnormal bone outgrowth, inflammation, and tumorigenesis. In a recent animal study with the proposed gel, it was found that the gel induced significant cortical bone ingrowth and thickened cortical bones at the injection sites. In addition, there was a significant increase in neovascularization within the cortical bones. Two major advantages of the device over the current bone healing devices available in the market are its ability to induce bone growth inwardly and suppress tumorous cell growth. Additionally, the anti-bacterial activity of the device is an improvement because bone fracture-related infection delays healing and increases complications and medical costs.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

该I-Corps项目更广泛的影响/商业潜力是定义用于骨愈合的天然多糖（糖）基凝胶器械的开发要求。最近，全球骨科手术数量急剧增加;这是由于骨科疾病的老龄化人口增加和道路事故发生率上升。此外，肥胖症和骨质疏松症患者的增加伴随着骨折的高发。目前可用的治疗包括自体移植物、同种异体移植物、骨移植物替代物（BGS）和骨形态发生蛋白（BMP）具有许多缺点。所提出的凝胶由天然多糖组成，其已被证明通过骨传导和血管化作用促进骨快速生长。此外，相关的抗菌特性被认为是一个重要的优势，因为超过70%的四肢远端骨折患者患有需要治疗的感染。预期所提出的凝胶装置的平移将帮助患者更快地恢复而不感染。此外，该治疗可能比市场上可用的BGS和BMP更具成本效益。治疗四肢远端骨折的全球市场估计为32.5亿美元。该I-Corps项目基于对用于骨骼愈合的天然多糖凝胶装置的开发成果的转化。该器械由结冷胶和FDA批准的成分组成，这些成分表现出强大的骨传导和血管生成活性，可实现快速骨愈合，并具有抗菌作用。目前骨缺损的治疗方法有自体移植物、同种异体移植物、骨移植替代物（BGS）和骨形态发生蛋白-2（BMP-2）。这些方法通常存在免疫排斥、疾病传播、弱骨形成能力、异常骨生长、炎症和肿瘤发生等问题。在最近的一项使用拟定凝胶的动物研究中，发现凝胶在注射部位诱导了显著的皮质骨长入和皮质骨增厚。此外，皮质骨内的新血管形成显著增加。该装置相对于目前市场上可获得的骨愈合装置的两个主要优点是其诱导骨向内生长和抑制肿瘤细胞生长的能力。此外，该设备的抗菌活性是一个进步，因为骨关节炎相关的感染延迟愈合，增加并发症和医疗成本。该奖项反映了NSF的法定使命，并已被认为是值得通过使用基金会的知识价值和更广泛的影响审查标准进行评估的支持。