I-Corps: A Novel Injectable Bone Healing Gel Device

这个I-Corps项目的更广泛的影响/商业潜力是确定用于骨愈合的天然多糖（糖）凝胶装置的开发要求。最近，全世界的骨科手术数量急剧增加；这是由于患有骨科疾病的老年人口增加和道路交通事故发生率上升。此外，肥胖和骨质疏松患者数量的增加伴随着骨折的高发。目前可用的治疗方法包括自体移植物、同种异体移植物、骨移植物替代品（BGSs）和骨形态发生蛋白（BMPs），它们存在许多缺陷。所提出的凝胶由一种天然多糖组成，该多糖已被证明通过骨传导和血管的作用促进骨的快速生长。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%的远端骨折患者患有需要治疗的感染。所提出的凝胶装置的翻译有望帮助患者更快地恢复而不会感染。此外，该疗法可能比市场上现有的BGSs和bmp更具成本效益。据估计，用于治疗远端肢体骨折的全球市场价值为32.5亿美元。这个I-Corps项目是基于翻译用于骨愈合的天然多糖凝胶装置的发展。该设备由结冷胶和fda批准的成分组成，具有很强的骨导电性和血管生成活性，具有快速骨愈合和抗菌作用。目前骨缺损的治疗方法有自体骨移植、同种异体骨移植、骨移植替代物（BGSs）和骨形态发生蛋白-2 （BMP-2）。这些方法经常遭受诸如免疫排斥、疾病传播、骨形成效力弱、骨生长异常、炎症和肿瘤发生等问题。在最近的一项动物研究中，发现该凝胶在注射部位诱导了显著的皮质骨向内生长和皮质骨增厚。此外，皮质骨内新生血管明显增加。与目前市场上可用的骨愈合装置相比，该装置的两个主要优点是它能够诱导骨内生长和抑制肿瘤细胞生长。此外，该设备的抗菌活性也有所提高，因为骨折相关感染会延迟愈合，增加并发症和医疗费用。该奖项反映了美国国家科学基金会的法定使命，并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，被认为值得支持。

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.