Multicenter Clinical Trial of Keratin Biomaterial for Peripheral Nerve Regeneration
Technical Report,15 Sep 2010,14 Sep 2015
Wake Forest University Health Sciences Winston-Salem United States
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Common injuries sustained by war fighters in Iraq and Afghanistan result from blast and shrapnel wounds which cause extensive damage to skin, bones, and nerves. The management of damaged peripheral nerves is challenging for patients and surgeons. Peripheral nerve transection injuries may fail to regenerate evenwhen managed surgically. These injuries are associated with long term disability and impaired function. Nerve guidance conduits have been developed for use in surgery to bridge the gap between transected nerve ends and to support nerve regeneration. A team of scientist and clinicians at Wake Forest School of Medicine has developed a keratin biomaterial hydrogel that can be used as luminal filler in nerve guidance conduits to facilitate nerve regeneration. Studies in mice, rabbits, and nonhuman primates have established the feasibility of this keratin hydrogel to promote nerve regeneration. A Phase I prospective, randomized trial was designed to compare nerve regeneration in patients sustaining peripheral nerve injuries treated either with keratin hydrogel and a nerve conduit or with a nerve conduit alone. The clinical trial was to be initiated as soon as the FDA provided an IND for the keratin biomaterial hydrogel. However, due to delays in the FDA approval process, the clinical study was not initiated. However, a fate and distribution study demonstrated that C14 labeled keratin hydrogel remained in high concentrations at the site where it was implanted intramuscularly.