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Accession Number ADA570218
Title Multicenter Clinical Trial of Keratin Biomaterial for Peripheral Nerve Regeneration.
Publication Date Oct 2012
Media Count 10p
Personal Author B. P. Smith L. A. Koman M. E. Van Dyke Z. Li
Abstract 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 even when 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 is 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 will be initiated as soon as the FDA provides an IND for the keratin biomaterial hydrogel.
Keywords Ammunition fragments
Clinical trials
Feasibility studies
Jet fighters
Keratin biomaterial hydrogel
Nerve conduit
Nerve repair
Peripheral nerve transection
Peripheral nervous system
Wounds and injuries

Source Agency Non Paid ADAS
NTIS Subject Category 57A - Anatomy
57S - Physiology
57E - Clinical Medicine
Corporate Author Wake Forest Univ., Winston-Salem, NC. School of Health Sciences.
Document Type Technical report
Title Note Annual rept. 15 Sep 2011-14 Sep 2012.
NTIS Issue Number 1314
Contract Number W81XWH-10-1-0894

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