I-Corps: A Novel Injectable Bone Healing Gel Device

这个i-Corps项目的更广泛的影响/商业潜力是确定开发基于天然多糖(糖)的骨愈合凝胶设备的要求。最近，全世界整形外科手术的数量急剧增加；这是由于患有整形外科疾病的老龄化人口增加和道路事故发生率上升所致。此外，肥胖和骨质疏松症患者数量的增加也伴随着骨折的高发生率。目前可用的治疗方法包括自体骨移植、同种异体骨移植、骨移植替代物(BGSS)和骨形态发生蛋白(BMPs)。建议的凝胶由一种天然多糖组成，它被证明通过骨传导和血管形成作用促进骨骼的快速生长。此外，相关的抗菌性能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。拟议中的凝胶装置的平移有望帮助患者更快地康复，而不会感染。此外，这种治疗方法可能比市场上提供的BGSS和BMP更具成本效益。据估计，全球市场价值32.5亿美元，用于治疗远端骨折。这个i-Corps项目是基于用于骨愈合的天然多糖凝胶设备的开发成果。该装置由结冷胶和FDA批准的成分组成，这些成分显示出强大的骨传导和血管生成活性，有助于快速骨愈合，并具有抗菌效果。目前治疗骨缺损的方法有自体骨移植、同种异体骨移植、骨移植替代物和骨形态发生蛋白-2(BMP-2)。这些方法经常遇到免疫排斥、疾病传播、成骨能力弱、异常骨生长、炎症和肿瘤形成等问题。在最近对所建议的凝胶进行的动物研究中，发现该凝胶在注射部位诱导了显著的皮质骨生长和皮质骨增厚。此外，皮质骨中的新生血管显著增加。与目前市场上可用的骨修复设备相比，该设备的两个主要优势是它能够向内诱导骨生长和抑制肿瘤细胞生长。此外，该设备的抗菌活性是一种改进，因为与骨折相关的感染推迟了愈合，增加了并发症和医疗成本。这一奖项反映了NSF的法定使命，并通过使用基金会的智力优势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.