A review of current approaches for decellularization, sterilization, and hemocompatibility testing on xenogeneic pericardium

Abstract

Decellularization, sterilization, and hemocompatibility are the main areas for biomaterials evaluation when the material is designed for medical implants. The glutaraldehyde fixation of xenogeneic pericardium graft is not fully capable of preventing implant rejection in the recipient. The decellularization process removes the cellular components from organs or tissue to form an extracellular matrix as a structural template, and this template can be used for tissue engineering applications. The decellularization can be performed by chemical, enzymatic or physical, or a combination of methods. Sterilization and hemocompatibility are essential for medical devices that come into contact with blood. The different sterilization treatments include gamma radiation, freeze-drying, ethylene oxide, peracetic acid, antibiotics, and ethanol. In this context, this study reviews the three major areas of decellularization, sterilization, and hemocompatibility of xenogeneic pericardium for tissue engineering applications. In this study, a brief overview of recent decellularization approaches and combinations such as chemical method, chemical and enzymatic method, and the physical and chemical method used to remove cellular material from the pericardium are discussed. In the different sterilization techniques, the sterilization efficiency and post sterilization results obtained by various research groups on pericardium scaffolds are discussed. Also, this review deals with in vitro hemocompatibility testing such as hemolysis, platelet adhesion, coagulation system, and activation of leucocytes for xenogeneic biomaterials.