ART-NERVE (Artificial peripheral nerve tissue for clinical use)

The research grant proposal “ArtNerve” aims to develop artificial nerve grafts for treating peripheral nerve injuries, which present a significant clinical challenge with limited treatment options. Current therapies often result in insufficient functional recovery and long-term adverse effects, impacting patients’ quality of life.

ArtNerve’s innovative approach lies in creating nerve grafts that closely mimic the natural structure of nerve tissue, specifically bands of Büngner structures, which are essential for guiding regenerating axons. This is achieved by mechanically aligning Schwann cells derived from human induced pluripotent stem cells (iPSCs) within a fibrin hydrogel using a custom-made bioreactor system. The project’s goals include establishing fully humanized nerve grafts, evaluating their regenerative capacity in vitro, and ensuring their clinical translatability through cryopreservation protocols.

ArtNerve as a product has the potential to revolutionize peripheral nerve injury treatment by offering a more effective solution that promotes faster and superior functional recovery. Thus, ArtNerve strives to improve patients’ quality of life, reduce the socioeconomic burden, and enable faster reintegration into the workforce.

Furthermore, the use of iPSC-derived Schwann cells offers the advantage of generating large quantities of Schwann cells without the need for donor nerve harvesting. Eventually, the use of universal donor iPSC-derived Schwann cells – as soon as commercially available – would allow the development of a cryopreserved, readily available product for off-the-shelf use.

In this project, key challenges will be tackled, including the translation from a murine-based system to a human iPSC-based model, the optimization of cell culture and mechanical stimulation protocols, and the identification of regulatory requirements for advanced therapeutic medicinal products. Early and proactive engagement with
clinical experts will be prioritized to ensure the developed nerve grafts are clinically applicable and accepted by customers.

To summarize, ArtNerve presents a promising solution to a pressing clinical need, with the potential to significantly improve the lives of patients suffering from peripheral nerve injuries. By addressing the limitations of current treatments and offering an effective approach, ArtNerve has the potential to make a substantial impact in the field of nerve regeneration.

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