Effects of Chemical and Radiation Sterilisation on the Biological and Biomechanical Properties of Decellularised Porcine Peripheral Nerves

Abstract

There is a clinical need for novel graft materials for the repair of peripheral nerve defects. A decellularisation process has been developed for porcine peripheral nerves, yielding a material with potentially significant advantages over other devices currently being used clinically (such as autografts and nerve guidance conduits). Grafts derived from xenogeneic tissues should undergo sterilisation prior to clinical use. It has been reported that sterilisation methods may adversely affect the properties of decellularised tissues, and therefore potentially negatively impact on the ability to promote tissue regeneration. In this study, decellularised nerves were produced and sterilised by treatment with 0.1% (v/v) PAA, gamma radiation (25–28 kGy) or E Beam (33–37 kGy). The effect of sterilisation on the decellularised nerves was determined by cytotoxicity testing, histological staining, hydroxyproline assays, uniaxial tensile testing, antibody labelling for collagen type IV, laminin and fibronectin in the basal lamina, and differential scanning calorimetry. This study concluded that decellularised nerves retained biocompatibility following sterilisation. However, sterilisation affected the mechanical properties (PAA, gamma radiation), endoneurial structure and basement membrane composition (PAA) of decellularised nerves. No such alterations were observed following E Beam treatment, suggesting that this method may be preferable for the sterilisation of decellularised porcine peripheral nerves.

Comprehensive ex vivo and in vivo preclinical evaluation of novel chemo enzymatic decellularized peripheral nerve allografts

“…Thirdly, the removal of certain ECM components by the different decellularization procedures could be associated with changes in the physical and biological properties of the generated DPNAs ( El Soury et al, 2021 ; Garcia-Garcia et al, 2021 ; Holland et al, 2021 ), something that was evaluated by the physical and biomechanical characterization of the DPNAs. These tests are essential tools to determine the suitability of the nerve substitutes to clinical practice and, interestingly, the decellularization methods described here did not significantly affect overall biomechanical properties of the nerves, obtaining biomechanical properties comparable to the native nerves used as control.…”

The effect of source animal age, decellularization protocol, and sterilization method on bovine acellular dermal matrix as a scaffold for wound healing and skin regeneration

“…However, physical, chemical, mechanical, and biological changes bring some troubles 66 . EO reacts with sulfhydryl, amino, and carboxyl groups in proteins and nucleic acid molecules within the microorganisms, leading to their inactivation 67 . Sterilization with EO gas is also conducted at room temperature.…”

“…66 EO reacts with sulfhydryl, amino, and carboxyl groups in proteins and nucleic acid molecules within the microorganisms, leading to their inactivation. 67 Sterilization with EO gas is also conducted at room temperature. It is easily penetrable and causes no alterations to most materials, but its trace residuals are toxic and need to be removed carefully.…”