Study Of The Immunogenicity Of The Collagen Class Of Medical Products

Collagen is usually applied to the manufacture of valves,frames and tissue repair materials which are often get in touch with important parts of human body in vivo and in vitro. So whether these materials will influence the immune system of the human body is an important safety index. Although our country has raised a requirement to detect the immunogenicity of this kind of product, but so far have not yet a concrete method to evaluate it. Some standards about Principles and methods for immunotoxicology testing of medical devices such as ASTM related standard and ISO10993-20 just provide some probable guidances and recommendations, did not give the concrete method that an experiment need.Therefore, search for a good experimental method become an urgent mission.In the research of experimental method of immunogenicity evaluation, the choice of the positive control is an important part. it could stably provide:a series of changed data when the experimental system changes. So we can evaluate the other teams according to it. Because the examination of the immunogenicity could be divided into two parts: cellular immunity evaluation and humoral immunity evaluation. This text has made a pilot study of whether BSA that ASTM standerd recommended positive contol of humoral immunity for immunotoxicology testing of medical devices could be the cellular immunity and humoral immunity evaluative positive contol for the testing of collagen products and the concrete method that this experiment need.Moreover, we use crosslinked and dis-crosslinked collagen as experimental matierials and analysised the data.on the aspect of the cellular immunity, we do the proliferation of lympholeukocyte and flow cytometry experiments. On the aspect of the humoral immunity we do mouse serum IgG and IgM assay and mouse anti-prince typeI collagen antibody assay experiment. Still we do organ weight and organ coefficient analysis,pathological section HE stain analysis. Through these experiments data , we analysis the influence of the eligible dose, the immune period and times to evaluate the immunogenicity of the experiment materials, and to summarize the stable and reliable methods.