I-Corps: A Novel Structured Nanofibrous Nerve Guidance Conduit for Nerve Regeneration

There are over 900,000 peripheral nerve repair procedures performed annually in the United States, injuries usually occur from traumatic injuries such as vehicle accidents. Severe nerve injuries result in the formation of a significant gap between the severed nerve stumps. When the gap is large, the clinical ?gold standard? for the treatment is to bridge the nerve gaps using one?s own nerve from a less important area. This technique is not ideal because the availability of the donor nerve is limited and the patient is exposed to the complications of a second surgical procedure. Many approaches have been examined for enhancing peripheral nerve regeneration. However, none of them have performed better than the 'gold standard' for repairing peripheral nerve injuries. This I-Corps team has developed a novel structured nanofiber-containing biodegradable nerve conduit, which can significantly enhance peripheral nerve regeneration to the level comparable to the gold standard in many aspects as indicated by preliminary animal studies. In this project, the team will further seek the commercialization potential for this nerve conduit. Nerve conduits may find tremendously important clinical uses and may be of significant impact on improving the quality of lives of patients with nerve injuries.The proposed solution for repairing large nerve gaps in this project is a spiral structured nerve guidance conduit, with multiple channels, and aligned nanofibers to increase surface area for cellular attachment, enhance cell migration, and improve neurite extension. This nerve guidance conduit is developed using an FDA pre-approved biodegradable and biocompatible polymer, polycaprolactone (PCL). As compared to other available nerve conduits, the proposed nerve conduit uses PCL alone without adding any biologics. This will be helpful to reduce the burden for regulatory approval and allow faster and easier commercialization of the conduit. In addition, the novel spiral structure can significantly increase surface areas for nerve regeneration, and the novel ways for presenting nanofibers onto the surface of complex structures can further augment surface areas and match the mechanical and nutrient requirements of the peripheral nerve regeneration. Most importantly, this nerve guidance conduit has shown promising results to treat large injured nerve gap as proven by preliminary animal studies. The aim for this project is to determine a clear pathway to commercialization and identify all the stakeholders that play a role. The team will create a prototype to test durability based on the requirements provided by the experts and also to further characterize the highly porous structures of the nerve conduits. The team would also like to interact with surgeons and industry experts to determine the pain points that they are experiencing to determine if the conduit can meet their requirements for clinical applications.