Comparative Analysis of Sterilization Methods for Placenta-Based Products using an Animal Model

Placenta-based products, known for their regenerative potential in various clinical applications, are either aseptically processed or require effective terminal sterilization methods to ensure safety and maintain their therapeutic properties. Providing an overview of a comparative analysis of healing rate in a full thickness animal model has been used to show the importance of evaluating the impact of sterilization on these materials in a biologically relevant context. The Sprague Dawley full thickness model is used to assess the in vivo response to sterilized placenta-based products, and to provide critical insights into immunogenicity, tissue integration, and the overall regenerative potential of these materials.<br/>Several sterilization methods, including gamma irradiation, ethylene oxide (ETO) gas sterilization, electron beam (e-beam), and various other methods have been employed to eliminate potential pathogens from placenta-based products. However, the choice of sterilization method can have varying effects on the biological activity and safety. In this study, we discuss the utilization of an animal model to assess the effects of different sterilization techniques on the safety and efficacy of placenta-based products. The placenta-based product tested is Artacent Wound®, a dehydrated dual layer amniotic graft, terminally sterilized with two different techniques. Furthermore, it addresses the importance of selecting appropriate animal models that closely mimic human physiology, ensuring that the findings are translatable to clinical applications. The animals are monitored for wound healing progress and adverse effects.<br/>In conclusion, employing relevant animal models allows for a more comprehensive evaluation of the impact of sterilization on these materials, bridging the gap between in vitro assessments and clinical applications.