Brushart, T M. (2011). Nerve Repair (Oxford University Press).
Centeno CJ, Al-Sayegh H, Freeman MD, Smith J, Murrell WD, Bubnov R A multi-center analysis of adverse events among two thousand, three hundred and seventy two adult patients undergoing adult autologous stem cell therapy for orthopaedic conditions. Int Orthop. 2016 Aug;40(8):1755-1765. doi: 10.1007/s00264-016-3162-y. Epub 2016 Mar 30. Erratum in: Int Orthop. 2018 Jan;42(1):223.
Center for Biologics Evaluation and Research, C for D. and R.H. Cellular & Gene Therapy Guidances - Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Draft Guidance.
Dezawa M, Takahashi I, Esaki M, Takano M, Sawada H Sciatic nerve regeneration in rats induced by transplantation of in vitro differentiated bone-marrow stromal cells. Eur J Neurosci. 2001 Dec;14(11):1771-6.
Ding F, Wu J, Yang Y, Hu W, Zhu Q, Tang X, Liu J, Gu X Use of tissue-engineered nerve grafts consisting of a chitosan/poly(lactic-co-glycolic acid)-based scaffold included with bone marrow mesenchymal cells for bridging 50-mm dog sciatic nerve gaps. Tissue Eng Part A. 2010 Dec;16(12):3779-90. doi: 10.1089/ten.TEA.2010.0299. Epub 2010 Sep 6.
Ducic I, Fu R, Iorio ML Innovative treatment of peripheral nerve injuries: combined reconstructive concepts. Ann Plast Surg. 2012 Feb;68(2):180-7. doi: 10.1097/SAP.0b013e3182361b23.
Dvali L, Mackinnon S Nerve repair, grafting, and nerve transfers. Clin Plast Surg. 2003 Apr;30(2):203-21. Review.
Frykman, G , and Gramyk, K. (1991). Results of Nerve Grafting In: Gelberman R. Operative nerve repair and reconstruction. (JB Lippincott).
Graham, James B , Xue, Qing-Shan, Neubauer, Debbie, and Muir, David (2009). A chondroitinase-treated, decellularized nerve allograft compares favorably to the cellular isograft in rat peripheral nerve repair. 2, 19-29
Guo Y, Chen G, Tian G, Tapia C Sensory recovery following decellularized nerve allograft transplantation for digital nerve repair. J Plast Surg Hand Surg. 2013 Dec;47(6):451-3. doi: 10.3109/2000656X.2013.778862. Epub 2013 Jul 15.
Hegde V, Shonuga O, Ellis S, Fragomen A, Kennedy J, Kudryashov V, Lane JM A prospective comparison of 3 approved systems for autologous bone marrow concentration demonstrated nonequivalency in progenitor cell number and concentration. J Orthop Trauma. 2014 Oct;28(10):591-8. doi: 10.1097/BOT.0000000000000113.
Hendrich C, Franz E, Waertel G, Krebs R, Jäger M Safety of autologous bone marrow aspiration concentrate transplantation: initial experiences in 101 patients. Orthop Rev (Pavia). 2009 Oct 10;1(2):e32. doi: 10.4081/or.2009.e32.
Hu J, Zhu QT, Liu XL, Xu YB, Zhu JK Repair of extended peripheral nerve lesions in rhesus monkeys using acellular allogenic nerve grafts implanted with autologous mesenchymal stem cells. Exp Neurol. 2007 Apr;204(2):658-66. Epub 2007 Jan 10.
Hu N, Wu H, Xue C, Gong Y, Wu J, Xiao Z, Yang Y, Ding F, Gu X Long-term outcome of the repair of 50 mm long median nerve defects in rhesus monkeys with marrow mesenchymal stem cells-containing, chitosan-based tissue engineered nerve grafts. Biomaterials. 2013 Jan;34(1):100-11. doi: 10.1016/j.biomaterials.2012.09.020. Epub 2012 Oct 11.
IJpma FF, Nicolai JP, Meek MF Sural nerve donor-site morbidity: thirty-four years of follow-up. Ann Plast Surg. 2006 Oct;57(4):391-5.
Isaacs J Major peripheral nerve injuries. Hand Clin. 2013 Aug;29(3):371-82. doi: 10.1016/j.hcl.2013.04.006. Epub 2013 Jun 12. Review.
Johnson PJ, Newton P, Hunter DA, Mackinnon SE Nerve endoneurial microstructure facilitates uniform distribution of regenerative fibers: a post hoc comparison of midgraft nerve fiber densities. J Reconstr Microsurg. 2011 Feb;27(2):83-90. doi: 10.1055/s-0030-1267834. Epub 2010 Oct 13.
Karabekmez FE, Duymaz A, Moran SL Early clinical outcomes with the use of decellularized nerve allograft for repair of sensory defects within the hand. Hand (N Y). 2009 Sep;4(3):245-9. doi: 10.1007/s11552-009-9195-6. Epub 2009 May 2.
Kragh, Kirby, J M., and Ficke, J.R. Combat casualty care : lessons learned from OEF and OIF. Chapter 9: Extremity Injury. (2012) Editor-in-chief, Martha K. Lenhart; medical editor, Eric Savitsky; military editor, Brian Eastridge. Pgs. 393-484
Lin MY, Manzano G, Gupta R Nerve allografts and conduits in peripheral nerve repair. Hand Clin. 2013 Aug;29(3):331-48. doi: 10.1016/j.hcl.2013.04.003. Review.
Lohmeyer JA, Siemers F, Machens HG, Mailänder P The clinical use of artificial nerve conduits for digital nerve repair: a prospective cohort study and literature review. J Reconstr Microsurg. 2009 Jan;25(1):55-61. doi: 10.1055/s-0028-1103505. Epub 2008 Nov 26. Review.
Lundborg G, Rosén B The two-point discrimination test--time for a re-appraisal? J Hand Surg Br. 2004 Oct;29(5):418-22. Review.
Lundborg G A 25-year perspective of peripheral nerve surgery: evolving neuroscientific concepts and clinical significance. J Hand Surg Am. 2000 May;25(3):391-414. Review.
Meek MF, Coert JH, Robinson PH Poor results after nerve grafting in the upper extremity: Quo vadis? Microsurgery. 2005;25(5):396-402.
Mimura T, Dezawa M, Kanno H, Sawada H, Yamamoto I Peripheral nerve regeneration by transplantation of bone marrow stromal cell-derived Schwann cells in adult rats. J Neurosurg. 2004 Nov;101(5):806-12.
Neubauer D, Graham JB, Muir D Nerve grafts with various sensory and motor fiber compositions are equally effective for the repair of a mixed nerve defect. Exp Neurol. 2010 May;223(1):203-6. doi: 10.1016/j.expneurol.2009.08.013. Epub 2009 Aug 22.
Noble J, Munro CA, Prasad VS, Midha R Analysis of upper and lower extremity peripheral nerve injuries in a population of patients with multiple injuries. J Trauma. 1998 Jul;45(1):116-22.
PRWeb (2015). AxoGen Inc.'s Avance Nerve Graft Data Presented During Bese Clinical Papers Session at the 70th Annual Meeting of the American Society for Surgery of the Hand. Vocus, Inc. Sep. 10, 2015
Reyes M, Verfaillie CM Characterization of multipotent adult progenitor cells, a subpopulation of mesenchymal stem cells. Ann N Y Acad Sci. 2001 Jun;938:231-3; discussion 233-5.
Rinker B, Liau JY A prospective randomized study comparing woven polyglycolic acid and autogenous vein conduits for reconstruction of digital nerve gaps. J Hand Surg Am. 2011 May;36(5):775-81. doi: 10.1016/j.jhsa.2011.01.030. Epub 2011 Apr 12.
Taras JS, Amin N, Patel N, McCabe LA Allograft reconstruction for digital nerve loss. J Hand Surg Am. 2013 Oct;38(10):1965-71. doi: 10.1016/j.jhsa.2013.07.008. Epub 2013 Aug 30.
Wangensteen KJ, Kalliainen LK Collagen tube conduits in peripheral nerve repair: a retrospective analysis. Hand (N Y). 2010 Sep;5(3):273-7. doi: 10.1007/s11552-009-9245-0. Epub 2009 Nov 24.
Weber RA, Breidenbach WC, Brown RE, Jabaley ME, Mass DP A randomized prospective study of polyglycolic acid conduits for digital nerve reconstruction in humans. Plast Reconstr Surg. 2000 Oct;106(5):1036-45; discussion 1046-8.
Zuniga JR Sensory outcomes after reconstruction of lingual and inferior alveolar nerve discontinuities using processed nerve allograft--a case series. J Oral Maxillofac Surg. 2015 Apr;73(4):734-44. doi: 10.1016/j.joms.2014.10.030. Epub 2014 Nov 13.
Clinical Evaluation of Decellularized Nerve Allograft With Autologous Bone Marrow Aspirate Concentrate (BMAC) to Improve Peripheral Nerve Repair and Functional Outcomes
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.