FDA approved guidance conduits and wraps for peripheral nerve injury: A review of materials and efficacy

Kehoe, S.; Zhang, X.F.; Boyd, Daniel

doi:10.1016/j.injury.2010.12.030

Cited by 617 publications

(595 citation statements)

References 126 publications

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“…30 Over the last years, evidence is accumulating that tubulization nerve repair can be a good alternative to traditional autografts in selected cases. 28,31,32 The clinical results presented in this article are in line with this grow-ing evidence.…”

Section: Discussionsupporting

confidence: 85%

Primary repair of crush nerve injuries by means of biological tubulization with muscle‐vein‐combined grafts

Tos¹,

Battiston²,

Ciclamini³

et al. 2012

Microsurgery

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Despite extensive research and surgical innovation, the treatment of peripheral nerve injuries remains a complex issue, particularly in nonsharp lesions. The aim of this study was to assess the clinical outcome in a group of 16 patients who underwent, in emergency, a primary repair for crush injury of sensory and mixed nerves of the upper limb with biological tubulization, namely, the muscle-vein-combined graft. The segments involved were sensory digital nerves in eight cases and mixed nerves in another eight cases (four median nerves and four ulnar nerves). The length of nerve defect ranged from 0.5 to 4 cm (mean 1.9 cm). Fifteen of 16 patients showed some degree of functional recovery. Six patients showed diminished light touch (3.61), six had protective sensation (4.31), and three showed loss of protective sensation (4.56) using Semmes-Weinstein monofilament test. All the patients who underwent digital nerve repair had favorable results graded as S4 in one case, S3þ in six cases, and S3 in one case. With respect to mixed nerve repair, we observed two S4, two S3þ, two S3, one S2, and one S0 sensory recovery. Less favorable results were observed for motor function with three M4, one M3, two M2, and two M0 recoveries. Altogether, the results of this retrospective study demonstrates that tubulization nerve repair in emergency, in case of short nerve gaps, may restore the continuity of the nerve avoiding secondary nerve grafting. This technique preserves donor nerve and, in case of failure, does not preclude a delayed repair with a nerve graft.Despite continuous researches and surgical innovations, the treatment of peripheral nerve injuries remains a com-plex problem. 1,2 Direct nerve repair is often impossible in case of loss of substance, thus requiring a different solu-tion to manage the gap. Nowadays, nerve autograft is still considered the ''gold standard'' for such lesions because it restores the continuity of nerve trunk without tension and offers and ideal support to regenerating axons. 2-7 A nerve autograft is rich of Schwann cells which have a major role in nerve repair due to basal membrane pro-teins (fibronectin and laminin) that promote and address axonal regeneration. [8][9][10][11] However, clinical outcome is often unsatisfactory and thus alternative types of nerve guides are sought. 1,5,12 The timing of intervention and the type of injury are major issues in nerve repair. As general rule, an open nerve injury should be early treated and repaired directly when optimal conditions, such as a) a clean-uncontami-nated wound and b) a sharp cut injury, are present. 12 Pri-mary nerve repair with nerve graft in crush injuries could be a risk because the extent of resection might be diffi-cult to judge in case of nerve laceration and contusion; in addition, sometimes it is better to avoid primary repair because of the conditions of the surrounding tissues. 13 In these circumstances, it may be advisable to identify and suture the nerve ends to avoid retraction, and then look-ing forward to a secondary recons...

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Section: Discussionsupporting

confidence: 85%

Primary repair of crush nerve injuries by means of biological tubulization with muscle‐vein‐combined grafts

Tos¹,

Battiston²,

Ciclamini³

et al. 2012

Microsurgery

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“…Characteristics of an ideal nerve guidance conduit (NGC) include biocompatibility, biodegradability, semi-permeability, the existence of longitudinal channels to promote axon regeneration, the presence of necessary guidance cues from extracellular matrix (ECM)-like components in addition to long term storage and ease of handling/suturing (Deumens et al, 2010;Kehoe et al, 2012;Spivey et al, 2012). Although many natural (e.g.…”

Section: Introductionmentioning

confidence: 99%

“…Although many natural (e.g. collagen) (Kemp et al, 2009;Li et al, 1991) and synthetic (Polycaprolactone (PCL), chitosan, polyglycolic acid (PGA)) (Jansen et al, 2004;Lee et al, 2012;Meek and Jansen, 2009;Yao et al, 2009) conduits have been developed in an attempt to replace the requirement for autografts, functional recovery that matches autograft levels is seldom observed (Kehoe et al, 2012).…”

Section: Introductionmentioning

confidence: 99%

“…Several studies have reported that decellularized allografts have consistently performed better than other commercially available grafts, which is most likely due to these grafts possessing the necessary architecture and guidance cues from nerve ECM components to promote axon regeneration (Karabekmez et al, 2009;Kehoe et al, 2012;Whitlock et al, 2009). A majority of protocols that decellularize nerve grafts are based on those developed by Sondell et al (Sondell et al, 1998) and Hudson et al(Hudson et al, 2004b) that predominantly use chemical decellularization agents.…”

Section: Introductionmentioning

confidence: 99%

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Decellularized grafts with axially aligned channels for peripheral nerve regeneration

Sridharan

Reilly

Buckley

2015

Journal of the Mechanical Behavior of Biomedical Materials

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At least 2 million people worldwide suffer annually from peripheral nerve injuries (PNI), with estimated costs of $7 billion incurred due to paralysis alone. The current "gold" standard for treatment of PNI is the autograft, which poses disadvantages such as high fiscal cost, possible loss of sensation at donor site and the requirement of two surgeries. Allografts are viable alternatives; however, intensive immunosuppressive treatments are often necessary to prevent host rejection. For this reason, significant efforts have been made to remove cellular material from allografts. These decellularized nerve grafts perform better than other clinically available grafts but not as well as autografts; therefore, current research on these grafts includes the incorporation of additional components such as growth factors and cells to provide chemical guidance to regenerating axons. However, effective cellular and axonal penetration is not achieved due to the small pore size (5-10μm) of the decellularized grafts.The overall objective of this study was to induce axially aligned channels in decellularized nerve grafts to facilitate enhanced cell penetration. The specific aims of this study were to optimize a decellularization method to enhance cellular removal, to induce axially aligned pore formation in decellularized grafts through a novel unidirectional freeze drying method, to study the bulk mechanical properties of these modified decellularized grafts and to assess cell penetration into these grafts. To this end we modified an existing decellularization protocol to improve cellular removal while preserving matrix structure in rat sciatic nerve sections. Standard freeze drying and unidirectional freeze drying were employed to impart the necessary pore architecture, and our results suggest that unidirectional freezing is a pertinent modification to the freeze drying process to obtain axially aligned channels. These highly porous scaffolds obtained using unidirectional freeze-drying possessed similar tensile properties to native nerve tissue and exhibited enhanced cellular penetration after 14 days of culture when compared to non-freeze dried and standard freeze-dried scaffolds. The results of this study not only highlight the importance of aligned pores of diameters ~20-60μm on cellular infiltration, but also presents unidirectional freeze drying as a viable technique for producing this required architecture in decellularized nerves. To the best of our knowledge, this study represents the first attempt to manipulate the physical structure of decellularized nerves to enhance cell penetration which may serve as a basis for future peripheral nerve regenerative strategies using decellularized allografts.

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“…Instead of autografts, artificial Nerve Guidance Channels (NGC) may be used to enhance regeneration avoiding availability and immune rejection problems (Kehoe, Zhang, & Boyd, 2012;Steed et al, 2011). The basic design are hollow tubes in which the proximal and the distal stumps of the injured nerve are inserted.…”

Section: Nrg1 To Promote Nerve Repair Peripheral Nerve Injury and Repairmentioning

confidence: 99%

Neuregulin 1 Role in Schwann Cell Regulation and Potential Applications to Promote Peripheral Nerve Regeneration

Gambarotta

Fregnan

Gnavi

et al. 2013

International Review of Neurobiology

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Neuregulin 1 (NRG1) is a multifunctional and versatile protein: its numerous isoforms can signal in a paracrine, autocrine or juxtacrine manner, playing a fundamental role during the development of the peripheral nervous system and during the process of nerve repair, suggesting that the treatment with NRG1 could improve functional outcome following injury. Accordingly, the use of NRG1 in vivo has already yielded encouraging results.The aim of this review is to focus on the role played by the different NRG1 isoforms during peripheral nerve regeneration and remyelination and to identify good candidates to be used for the development of tissue engineered medical devices delivering NRG1, with the final goal to promote better nerve repair.

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FDA approved guidance conduits and wraps for peripheral nerve injury: A review of materials and efficacy

Cited by 617 publications

References 126 publications

Primary repair of crush nerve injuries by means of biological tubulization with muscle‐vein‐combined grafts

Primary repair of crush nerve injuries by means of biological tubulization with muscle‐vein‐combined grafts

Decellularized grafts with axially aligned channels for peripheral nerve regeneration

Neuregulin 1 Role in Schwann Cell Regulation and Potential Applications to Promote Peripheral Nerve Regeneration

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