Clinical Evaluation of Decellularized Nerve Allograft with Autologous Bone Marrow Stem Cells to Improve Peripheral Nerve Repair and Functional Outcomes
Technical Report,01 Jul 2016,30 Jun 2017
Henry M. Jackson Foundation for the Advancement of Military Medicine Inc Bethesda United States
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The purpose of this study is to evaluate the safety of the nerve allograft and BMSC sequentially to repair peripheral nerve gaps of the ulnar and median nerves of the upper extremities between 2 and 7 centimeters cm in length. Subjects will be followed for 18months post-surgery. Secondary outcomes will be examined to evaluate the efficacy of the co-treatment for nerve repair compared to Avance Nerve Graft and BMSC treatments alone. The study is designed to treat up to 24 patients using the sequential treatment of nerve allograft and BMSC. This is a prospective, observational trial to evaluate the safety of Avance nerve graft and BMSC and to measure the efficacy of the synergistic treatment for peripheral nerve repair.
- Medicine and Medical Research