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A sterilization method for decellularized xenogeneic cardiovascular scaffolds

journal contribution
posted on 01.03.2019 by Catia Fidalgo, Laura Iop, Manuela Sciro, M. Harder, Dimosthenis Mavrilas, Sotiris Korossis, Andrea Bagno, Giorgio Palu, Paola Aguiari, Gino Gerosa
Decellularized xenogeneic scaffolds have shown promise to be employed as compatible and functional cardiovascular biomaterials. However, one of the main barriers to their clinical exploitation is the lack of appropriate sterilization procedures. This study investigated the efficiency of a two-step sterilization method, antibiotics/antimycotic (AA) cocktail and peracetic acid (PAA), on porcine and bovine decellularized pericardium. In order to assess the efficiency of the method, a sterilization assessment protocol was specifically designed, comprising: i) controlled contamination with a known amount of bacteria; ii) sterility test; iii) identification of contaminants through MALDI-TOF (Matrix-Assisted Laser Desorption/ Ionization Time-of-Flight) mass spectrometry and iv) quantification by the Most Probable Number (MPN) method. This sterilization assessment protocol proved to be a successful tool to monitor and optimize the proposed sterilization method. The treatment with AA + PAA method provided sterile scaffolds while preserving the structural integrity and biocompatibility of the decellularized porcine and bovine tissues. However, surface properties and cellular adhesion resulted slightly impaired on porcine pericardium. This work developed a sterilization method suitable for decellularized pericardial scaffolds that could be adopted for in vivo tissue engineering. Together with the proposed sterilization assessment protocol, this decontamination method will foster the clinical translation of decellularized xenogeneic substitutes.


This research was funded by the People Programme (Marie Curie Actions) of the European Union’s Seventh Framework Programme FP7/2007–2013/ITN-TECAS under REA grant agreement n 317512.



  • Mechanical, Electrical and Manufacturing Engineering

Published in

Acta Biomaterialia




282 - 294


FIDALGO, C. ... et al., 2018. A sterilization method for decellularized xenogeneic cardiovascular scaffolds. Acta Biomaterialia, 67, pp. 282 - 294.


© Published by Elsevier Ltd on behalf of Acta Materialia Inc.


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