Biointegration of a partially decellularized tracheal scaffold in a porcine model - preliminary results.

Some pediatric tracheal pathologies remain therapeutic dead ends for which current palliative strategies are fraught with serious complications. With the aim of a tracheal replacement, our team has previously developed and patented a clinical grade partially decellularized trachea (PDT) from porcine tracheas. The aim of this work was to study and compare the biointegration mechanisms of this PDT in vivo, in a pig cervical muscle, with or without immunosuppressant. The secondary objective was to evaluate the optimal maturation time of the PDT in this heterotopic position. In total, 11 female Large White/Landrace pigs, weighing between 50 and 70 kg were included in this study. The mean age of the animals at the implantation was 4.8 months. The PDTs were implanted in a cervical muscle of pigs for either 28 days, with or without cyclosporin A treatment, or for 56 days without immunosuppression. Histological evaluation showed very good PDT biointegration, characterized by neovascularization and fibroblast colonization, and no detectabale infection. Additionally, tissue and blood analyses showed no signs of graft rejection or surrounding tissue necrosis. Immunosuppression did not show any superiority in terms of biointegration after 28 days of treatment. After 56 days of implantation, a more significant degradation of the cartilage. Therefore, the optimal condition for PDT maturation proved to be 28 days, without immunosuppression.