A novel device for the automatic decellularization of biological tissues

Abstract

Objectives: Decellularized biological scaffolds represent a promising solution for tissue engineering. They offer a good substrate for cells in terms of biochemical composition, ultrastructure and mechanical properties without generating an immunogenic response. The aim of this study was to design and develop a device for the automatic decellularization of biological tissues to overcome manual operation limits, toward a good manufacturing practice-compliant process. Methods: A versatile, modular and easy-to-use device was designed, able to automatically exchange decellularization fluids and to provide mechanical shaking according to a user-defined protocol. Preliminary decellularization tests were made on porcine abdominal aortas comparing results between conventional process and device-operated process using water, sodium deoxycholate and DNase. Vessels were processed up to 4 cycles of the protocol and after each decellularization cycle histological analyses (hematoxylin-eosin, Movat pentachrome and DAPI stainings) were observed. Preliminary mechanical tests were also performed to compare the mechanical behavior of blood vessels processed with the 2 methods mentioned above. Results: Briefly, the device consists of decellularization chambers, a shaking system and hydraulic modules for the exchange of fluids. The device was bench-tested for functionality and reliability with positive outcomes. The protocol used revealed to be effective, with a progressive tissue decellularization through repeated cycles. No difference between manual and automated operation was observed in histological or mechanical analyses. Conclusions: The developed device is able to automate the decellularization process lowering operator- related risks, and is a reliable and functional tool for clinical use. © 2012 Wichtig Editore.