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This is an early access version, the complete PDF, HTML, and XML versions will be available soon.
Article

Peripheral Nerve Decellularisation Protocol for Allogeneic Transplantation: From Tissue Procurement to Banking

by
Marco Govoni
1,*,
Leonardo Vivarelli
1,
Nicola Fazio
2,
Federico Bolognesi
3,
Viscardo Paolo Fabbri
4,
Alessandra Maso
5,
Elisa Storni
5,
Giulia Querzoli
6,7,
Deyanira Contartese
8,
Stefania Pagani
8,
Luca Cavazza
8,
Marta Pluchino
1,
Lucia De Franceschi
1,
Gianluca Giavaresi
8 and
Dante Dallari
1
1
Reconstructive Orthopaedic Surgery and Innovative Techniques–Musculoskeletal Tissue Bank, IRCCS Istituto Ortopedico Rizzoli, 40136 Bologna, Italy
2
Technology Transfer Office, IRCCS Istituto Ortopedico Rizzoli, 40136 Bologna, Italy
3
Maxillofacial Surgery Unit, Head and Neck Department, San Paolo University Hospital, University of Milan, 20142 Milan, Italy
4
Department of Laboratory Medicine and Pathology, Azienda USL of Modena, 41121 Modena, Italy
5
Laboratory of Microbiology and GMP Quality Control, IRCCS Istituto Ortopedico Rizzoli, 40136 Bologna, Italy
6
Pathology Unit, IRCCS Azienda Ospedaliero Universitaria di Bologna, 40138 Bologna, Italy
7
Department of Medical and Surgical Sciences (DIMEC), University of Bologna, 40138 Bologna, Italy
8
Surgical Sciences and Technologies, IRCCS Istituto Ortopedico Rizzoli, 40136 Bologna, Italy
*
Author to whom correspondence should be addressed.
Int. J. Mol. Sci. 2025, 26(16), 7937; https://doi.org/10.3390/ijms26167937 (registering DOI)
Submission received: 15 July 2025 / Revised: 14 August 2025 / Accepted: 15 August 2025 / Published: 17 August 2025
(This article belongs to the Special Issue Advances in Peripheral Nerve Regeneration)
Versions Notes

Abstract

Peripheral nerve injuries affect over one million individuals annually worldwide due to various causes such as trauma, metabolic disorders, and autoimmune diseases. While autologous nerve grafting remains the gold standard for treating large-gap nerve injuries, its limitations, including limited tissue availability, donor site morbidity, infection risk, and suboptimal functional recovery, have spurred interest in alternative approaches. Among these, allogeneic nerve grafting has emerged as a promising option, offering structural and functional advantages due to the native architecture of donor nerves. However, immune rejection due to histocompatibility antigens remains a significant challenge. Decellularisation protocols utilising mild detergents have shown the most promise in preserving the extracellular matrix’s structural and regenerative properties while mitigating immunogenicity. The study aimed to adapt and validate a decellularisation protocol for human nerves within our tissue bank, adhering to European and national regulatory guidelines. The protocol, based on the cleanroom-compliant method previously developed by our group, was optimised to reduce tissue handling time and ensure regulatory compliance. Decellularised sural nerves were assessed for extracellular matrix preservation and sterility using European (EU) Pharmacopoeia and European Directorate for the Quality of Medicines & HealthCare (EDQM) guidelines. The results demonstrated the feasibility of producing high-quality acellular nerve allografts (ANAs) that are suitable for peripheral nerve repair, paving the way for cost-effective and widely accessible grafting solutions.
Keywords: acellular allogeneic nerve; allogeneic nerve transplantation; decellularisation; ISO Class A cleanroom protocol acellular allogeneic nerve; allogeneic nerve transplantation; decellularisation; ISO Class A cleanroom protocol

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MDPI and ACS Style

Govoni, M.; Vivarelli, L.; Fazio, N.; Bolognesi, F.; Fabbri, V.P.; Maso, A.; Storni, E.; Querzoli, G.; Contartese, D.; Pagani, S.; et al. Peripheral Nerve Decellularisation Protocol for Allogeneic Transplantation: From Tissue Procurement to Banking. Int. J. Mol. Sci. 2025, 26, 7937. https://doi.org/10.3390/ijms26167937

AMA Style

Govoni M, Vivarelli L, Fazio N, Bolognesi F, Fabbri VP, Maso A, Storni E, Querzoli G, Contartese D, Pagani S, et al. Peripheral Nerve Decellularisation Protocol for Allogeneic Transplantation: From Tissue Procurement to Banking. International Journal of Molecular Sciences. 2025; 26(16):7937. https://doi.org/10.3390/ijms26167937

Chicago/Turabian Style

Govoni, Marco, Leonardo Vivarelli, Nicola Fazio, Federico Bolognesi, Viscardo Paolo Fabbri, Alessandra Maso, Elisa Storni, Giulia Querzoli, Deyanira Contartese, Stefania Pagani, and et al. 2025. "Peripheral Nerve Decellularisation Protocol for Allogeneic Transplantation: From Tissue Procurement to Banking" International Journal of Molecular Sciences 26, no. 16: 7937. https://doi.org/10.3390/ijms26167937

APA Style

Govoni, M., Vivarelli, L., Fazio, N., Bolognesi, F., Fabbri, V. P., Maso, A., Storni, E., Querzoli, G., Contartese, D., Pagani, S., Cavazza, L., Pluchino, M., De Franceschi, L., Giavaresi, G., & Dallari, D. (2025). Peripheral Nerve Decellularisation Protocol for Allogeneic Transplantation: From Tissue Procurement to Banking. International Journal of Molecular Sciences, 26(16), 7937. https://doi.org/10.3390/ijms26167937

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