Nerve regeneration using artificial biodegradable conduits is of increasing interest. The aim of this study is to evaluate the regeneration and maturation of a nerve after long-term implantation (2 years) of a biodegradable poly-L-lactide/poly-epsilon-caprolactone (PLLA/PCL) copolymeric nerve guide in the sciatic nerve of the rat. After harvesting, we evaluated both the regenerated nerves and the controls, using light microscopy, transmission electron microscopy, and morphometric techniques. Remnants of biomaterial were still present after 2 years of implantation, but the foreign body reaction was very mild at this stage, due to the rounded shapes of the polymer debris. Morphometric analysis showed significant differences between the regenerated nerve and the normal sciatic nerve: the number of myelinated fibers is higher, and the mean fiber diameter of the myelinated fibers in the regenerated nerve is smaller. In conclusion, the results demonstrate that the new PLLA/PCL nerve guide can provide optimal conditions for regeneration and maturation of damaged nerves.
The aim of this study is to evaluate the functional and cell biological applicability of a two-ply nerve guide constructed of a PLLA/PCL (i.e. poly-L-lactide and poly-~-caprolactone) copolymer. To do so, we performed a cytotoxicity test, a subcutaneous biodegradation test and an in situ implantation study in the sciatic nerve of the rat. The nerve guide copolymer was found to be non-toxic, according to ISO/EN standards, and it showed a mild foreign body reaction and complete fibrous encapsulation after implantation. Onset of biodegradation of the inner layer was seen after one month of implantation. After 18 months of implantation complete fragmentation was observed, as well as a secondary inflammatory response characterized by foreign body giant cell activity and phagocytosis of polymer debris. Recovery of both motor and sensory nerve function was observed in all nerve guides.
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