Preclinical testing of immunotoxicity for animal-derived dermal materials

Animal derived materials have been widely used in biomedical products owing to their good biocompatibility and appropriate mechanical properties. It is crucial to evaluate the immunotoxicity of such materials in preclinical testing to prevent severe immune responses in patients. In this study, a pipeline of immunotoxicity tests was established to evaluate animal-derived materials before de-cellularization and final products. This pipeline contains a serial of animal tests on BALB/c mice and an in vitro quantification test for a-Gal antigen. It is well-recognized that the interaction between materials and patients profoundly alters immune responses, thus, a comprehensive dataset including body weight, immune organ coefficient, histopathology, peripheral hematology, serum immunoglobulin level, spleen lymphocyte proliferation rate, and their subpopulation was created and analyzed using the SPSS tool. These results clearly suggested that the de-cellularized materials possessed better biocompatibility, in addition, the a-Gal antigen content was effectively decreased by 96.0 ​% after de-cellularization. Thus, this study confirmed that this multi-step enzymatic de-cellularization treatment is a potent method to reduce the immunotoxicity of animal-derived biomaterials. Moreover, the experimental pipeline will likely be transferable to other biomedical materials and products.