Development of Transplantable Tissue Engineered Nerve Grafts Consisting of Stretch-Grown Axons From Swine

Peripheral nerve injuries (PNIs) present a serious medical concern, constituting approximately 100,000 neurosurgical procedures in the US and Europe annually. Despite this large number, only 50% of patients achieve good to normal restoration of function following surgical repair. This is due to current insufficiencies with PNI repair strategies to treat major nerve trauma, defined as loss of a large segment of nerve (i.e., >5 cm). Despite significant efforts, PNI repair has not developed past nerve guidance tubes (NGTs) to bridge small gaps or autografts for larger defects. Our research team, in conjunction with Axonia Medical, is developing novel tissue-engineered nerve grafts (TENGs) that not only have the potential to exceed the performance of autografts, but also to repair currently untreatable PNI. We hypothesize that TENGs enclosed within NGTs will promote axonal regeneration, target reinnervation, and functional restoration in a swine model of major PNI at lengths greater than tubes alone or an autograft can restore.