Clinical Evaluation of Decellularized Nerve Allograft with Autologous Bone Marrow Stem Cells to Improve Peripheral Nerve Repair and Functional Outcomes
Technical Report,01 Jul 2018,30 Jun 2019
HENRY M JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE BETHESDA United States
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The current award is a phase I safety study n12 evaluation of the synergistic effect of the co-treatments of a commercially available decellularized processed peripheral nerve allograft scaffold Avance registered trademark Nerve Graft, AxoGen, Alachua FL with autologous bone marrow stem cells BMSC for the reconstruction of mixed peripheral nerve gaps between 3 and 7 cm in length. Each treatment separately has been shown to have an established safety record. Avance has been used in more than 10,000 surgeries without a reported adverse event. The current standard of care for nerve injury, the autograft, has significant limitations the source and quantities of autologous tissue needed for repairs are limited, and when faced with severe trauma these donor sites are not viable due to concurrent injury. Use of a decellularized nerve graft mitigates concerns of donor site morbidity, decreases surgical time and has substantially equivalent outcomes. Augmenting the scaffold with the patients own BMSCs may allow for point of care treatment with the potential to enhance the regenerative ability of the wound-healing environment. The proposed use of an existing commercially available scaffold with an autologous stem cell transplant, both with proven safety records, would establish a safety profile and provide a proof of principle for this type of approach.
- Medicine and Medical Research