Trial reportEuropean journal of medical research2017
Clinical and biometrical 12-month follow-up in patients after reconstruction of the sural nerve biopsy defect by the collagen-based nerve guide Neuromaix.
Trial report in European journal of medical research, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
22 citing papers in PubMed, 54 citations in OpenAlex.
- Role of polymeric nanocomposite for tissue engineering applications.RSC advances · 2026Review
- Hydrogels and cryogels as in vitro engineered 3D neurodegenerative models: scope and significance.Journal of materials science. Materials in medicine · 2026Review
- Engineering neural recovery: Micro/nano-structured materials for nerve regeneration.Materials today. Bio · 2025Review
- Novelties and limitations of tissue-engineered materials in treating traumatic nerve injuries: a mini review.Frontiers in cell and developmental biology · 2025Review
- The Role of Tissue Engineering and Three-Dimensional-Filled Conduits in Bridging Nerve Gaps: A Review of Recent Advancements.Journal of hand surgery global online · 2024Review
- Nanomedicine in Neuroprotection, Neuroregeneration, and Blood-Brain Barrier Modulation: A Narrative Review.Medicina (Kaunas, Lithuania) · 2024Review
- Collagen for neural tissue engineering: Materials, strategies, and challenges.Materials today. Bio · 2023Review
- Closing the Gap: Bridging Peripheral Sensory Nerve Defects with a Chitosan-Based Conduit a Randomized Prospective Clinical Trial.Journal of personalized medicine · 2022Article
- Characterization of a Novel Aspect of Tissue Scarring Following Experimental Spinal Cord Injury and the Implantation of Bioengineered Type-I Collagen Scaffolds in the Adult Rat: Involvement of Perineurial-like Cells?International journal of molecular sciences · 2022Article
- Tissue Engineered Neurovascularization Strategies for Craniofacial Tissue Regeneration.ACS applied bio materials · 2022Review
- The application of collagen in the repair of peripheral nerve defect.Frontiers in bioengineering and biotechnology · 2022Review
- 'EngNT' - Engineering live neural tissue for nerve replacement.Emerging topics in life sciences · 2021Article
- Biofabrication of natural hydrogels for cardiac, neural, and bone Tissue engineering Applications.Bioactive materials · 2021Review
- Applications of nanomaterials in tissue engineering.RSC advances · 2021Review
- Advances and clinical challenges for translating nerve conduit technology from bench to bed side for peripheral nerve repair.Cell and tissue research · 2021Review
- A State-of-the-Art of Functional Scaffolds for 3D Nervous Tissue Regeneration.Frontiers in bioengineering and biotechnology · 2021Review
- Modification of tubular chitosan-based peripheral nerve implants: applications for simple or more complex approaches.Neural regeneration research · 2020Review
- Repair of long segmental ulnar nerve defects in rats by several different kinds of nerve transposition.Neural regeneration research · 2019Article
- Fibroadhesive scarring of grafted collagen scaffolds interferes with implant-host neural tissue integration and bridging in experimental spinal cord injury.Regenerative biomaterials · 2019Article
- Laminin-Coated Electrospun Regenerated Silk Fibroin Mats Promote Neural Progenitor Cell Proliferation, Differentiation, and SurvivalFrontiers in bioengineering and biotechnology · 2019Article
Corrections and comments
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Authors and funding
9 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
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.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.