Efficacy and safety of novel collagen conduits filled with collagen filaments to treat patients with peripheral nerve injury: A multicenter, controlled, open-label clinical trial

Saeki, Masaomi; Tanaka, Kenji; Imatani, Junya; Okamoto, Hideki; Watanabe, Kentaro; Nakamura, Toshiyasu; Gotani, Hiroyuki; Ohi, Hiroyuki; Nakamura, Ryogo; Hirata, Hitoshi

doi:10.1016/j.injury.2018.03.011

Cited by 37 publications

(34 citation statements)

References 19 publications

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“…The rate of recovery of sensory function at 12 months was 75% (36/49) for the RENERVE® group and 73.7% (28/38) in the autologous nerve group. No serious adverse events directly associated with the use of the RENERVE® were identified [10].…”

Section: Discussionmentioning

confidence: 99%

A case report of a long-term abandoned torn lingual nerve injury repaired by collagen nerve graft induced by lower third molar extraction

Fujita

Mizobata

Nakanishi

et al. 2019

Maxillofac Plast Reconstr Surg

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Background: The lingual nerve plays an important role in multiple functions, including gustatory sensation and contact sensitivity and thermosensitivity. Misdiagnosed conservative treatments for serious lingual nerve (LN) injuries can induce the patient to serious mental disability. After continuous observation and critical diagnosis of the injury, in cases involving significant disruption of lingual nerve function, microneurosurgical reconstruction of the nerve is recommended. Direct anastomosis of the torn nerve ends without tension is the recommended approach. However, in cases that present significant gaps between the injured nerve ends, nerve grafts or conduits (tubes of various materials) are employed. Recently, various reconstruction materials for peripheral nerves were commercially offered especially in the USA, but the best method and material is still unclear in the world. There currently exists no conventional protocol for managing LN neurosensory deficiency in regard to optimal methods and the timing for surgical repair. In Japan, the allograft collagen nerve for peripheral nerves reconstruction was permitted in 2017, and we tried to use this allograft nerve and got a recommendable result. Case presentation: This report is a long-term abandoned torn LN reconstructed with allograft nerve induced by the lower third molar extraction. Conclusions: In early sick period, with the exact diagnosis, the LN disturbance should be managed. In a serious condition, the reconstruction with allograft nerve is one of the recommendable methods.

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Section: Discussionmentioning

confidence: 99%

A case report of a long-term abandoned torn lingual nerve injury repaired by collagen nerve graft induced by lower third molar extraction

Fujita

Mizobata

Nakanishi

et al. 2019

Maxillofac Plast Reconstr Surg

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“…10 mm long hollow conduits reported better results in rat nerve regeneration and muscle re-innervation if compared to collagen polyglycolic acid (PGA)-filled conduits (Saltzman et al, 2019). A conduit made by mixing types I and III collagen filled with collagen filaments was not inferior to autologous graft in treating 30 mm nerve defects, with 80% of patients reporting sensory recovery after 12 months (Saeki et al, 2018). There are few collagen nerve conduits approved by the Food and Drug Administration (FDA) and Conformity Europe (CE).…”

Section: Collagenmentioning

confidence: 99%

Natural-Based Biomaterials for Peripheral Nerve Injury Repair

Fornasari

Carta

Gambarotta

et al. 2020

Front. Bioeng. Biotechnol.

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Peripheral nerve injury treatment is a relevant problem because of nerve lesion high incidence and because of unsatisfactory regeneration after severe injuries, thus resulting in a reduced patient's life quality. To repair severe nerve injuries characterized by substance loss and to improve the regeneration outcome at both motor and sensory level, different strategies have been investigated. Although autograft remains the gold standard technique, a growing number of research articles concerning nerve conduit use has been reported in the last years. Nerve conduits aim to overcome autograft disadvantages, but they must satisfy some requirements to be suitable for nerve repair. A universal ideal conduit does not exist, since conduit properties have to be evaluated case by case; nevertheless, because of their high biocompatibility and biodegradability, natural-based biomaterials have great potentiality to be used to produce nerve guides. Although they share many characteristics with synthetic biomaterials, natural-based biomaterials should also be preferable because of their extraction sources; indeed, these biomaterials are obtained from different renewable sources or food waste, thus reducing environmental impact and enhancing sustainability in comparison to synthetic ones. This review reports the strengths and weaknesses of natural-based biomaterials used for manufacturing peripheral nerve conduits, analyzing the interactions between natural-based biomaterials and biological environment. Particular attention was paid to the description of the preclinical outcome of nerve regeneration in injury repaired with the different natural-based conduits.

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“…Furthermore, tremendous attention was directed towards clinically relevant artificial grafts, namely nerve guidance conduits that exhibit outstanding capacity to regenerate the injured peripheral nerves [74,75,76]. Herein, the current approaches consider acellular grafts (including membranes, meshes, scaffolds, tubes and gels) derived from ECM components [77,78,79,80,81] or new biomaterial-based architectures [82,83,84,85,86].…”

Section: Nervous System Regenerative Therapymentioning

confidence: 99%

Nanomaterial-Based Approaches for Neural Regeneration

Teleanu

Gherasim

Gherasim³

et al. 2019

Pharmaceutics

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Mechanical, thermal, chemical, or ischemic injury of the central or peripheral nervous system results in neuron loss, neurite damage, and/or neuronal dysfunction, almost always accompanied by sensorimotor impairment which alters the patient’s life quality. The regenerative strategies for the injured nervous system are currently limited and mainly allow partial functional recovery, so it is necessary to develop new and effective approaches for nervous tissue regenerative therapy. Nanomaterials based on inorganic or organic and composite or hybrid compounds with tunable physicochemical properties and functionality proved beneficial for the transport and delivery/release of various neuroregenerative-relevant biomolecules or cells. Within the following paragraphs, we will emphasize that nanomaterial-based strategies (including nanosized and nanostructured biomaterials) represent a promising alternative towards repairing and regenerating the injured nervous system.

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Efficacy and safety of novel collagen conduits filled with collagen filaments to treat patients with peripheral nerve injury: A multicenter, controlled, open-label clinical trial

Cited by 37 publications

References 19 publications

A case report of a long-term abandoned torn lingual nerve injury repaired by collagen nerve graft induced by lower third molar extraction

A case report of a long-term abandoned torn lingual nerve injury repaired by collagen nerve graft induced by lower third molar extraction

Natural-Based Biomaterials for Peripheral Nerve Injury Repair

Nanomaterial-Based Approaches for Neural Regeneration

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