I-Corps: A Novel Injectable Bone Healing Gel Device

University Of Toledo, Toledo OH

Investigators

Abstract

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.