Clinical and biometrical 12-month follow-up in patients after reconstruction of the sural nerve biopsy defect by the collagen-based nerve guide Neuromaix

Abstract

Many new strategies for the reconstruction of peripheral nerve injuries have been explored for their effectiveness in supporting nerve regeneration. However only a few of these materials were actually clinically evaluated and approved for human use. This open, mono-center, non-randomized clinical study summarizes the 12-month follow-up of patients receiving reconstruction of the sural nerve biopsy defect by the collagen-based nerve guide Neuromaix. Neuromaix was implanted as a micro-structured, two-component scaffold bridging 20–40 mm nerve defects after sural nerve biopsy in twenty patients (eighteen evaluated, two lost in follow-up). Safety of the material was evaluated by clinical examination of wound healing. Performance was assessed by sensory testing of modalities, pain assessment, and palpation for the Hoffmann–Tinel’s sign as well as demarcating the asensitive area at each follow-up visit. Every patient demonstrated uneventful wound healing during the complete 12-month time course of the study. Two patients reported complete return of sensation, whereas eleven out of eighteen patients reported a positive Hoffmann–Tinel’s sign at the lower leg with simultaneous reduction of the asensitive area by 12 months. Our data show that Neuromaix can be implanted safely in humans to bridge sural nerve gaps. No procedure-related, adverse events, or severe adverse events were reported. These first clinical data on Neuromaix provide promising perspectives for the bridging of larger nerve gaps in combined nerves, which should be investigated more through extensive, multi-center clinical trials in the near future.Electronic supplementary materialThe online version of this article (doi:10.1186/s40001-017-0279-4) contains supplementary material, which is available to authorized users.

Fundamentals and Current Strategies for Peripheral Nerve Repair and Regeneration

“…To achieve that, collagen is extremely dynamic, undergoing constant modifications to deliver proper physiologic functions [131]. longitudinal guidance channels is capable of providing mechanical support to sprouting DRGs axons and can offer a shielding niche for nerve cells [178].…”

Appropriate Animal Models for Translational Nerve Research

“…It is also true, however, that whenever clinical outcome after nerve reconstruction with the approved nerve guides has been analyzed in a prospective, randomized, and controlled way, the results have been variable from very good to poor and therefore certainly less convincing than in preclinical evaluation (Boeckstyns et al 2013;Lohmeyer et al 2014;Kaplan et al 2015;Means et al 2016;Neubrech et al 2018). But again, until today no better preclinical models exist, and the author of this chapter is also aware of only one attempt in which a novel nerve graft development was comprehensively analyzed in the rat sciatic nerve model followed by a first-inhuman study with repair of sural nerves after biopsy procedures (Bozkurt et al 2017;van Neerven et al 2017).…”

Current development of biodegradable polymeric materials for biomedical applications

“… 22 In other studies, collagen has also been successfully used as a scaffold in nerve and bladder engineering. 24 – 26 Additionally, a suture-free, 3D-collagen matrix graft – DuraGen ® (Integra LifeSciences) – has been developed for spinal dural repair and regeneration and is currently approved by the FDA. 27 …”