Biological Safety Evaluation Of Human Amniotic Membrane

Objective:Evaluate the immunogenicity of human amniotic membrane through the vitro test——lymphocyte proliferation test,and vivo animal tests include two models.The two models of rabbit hypodermic implantation and moderate acid burn in rabbit cornea were established.Methods:1.Vitro test——lymphocyte proliferation test to evaluate the possibility of immunogenicity of the human amniotic membrane.2.In subchronic toxicity test,samples(the human amniotic membrane and similar product)were imbedded hypo sac of rabbits.During embedding period,rabbits were weighed in and clinical observed.After this period,pathologic dissection was applied to analyze generic behavior,hematology,blood biochemistry and weigh of organs.Results were be analyzed by statistic assay.3.The model of moderate acid burn in rabbit cornea was established.After transplantation,we observed the situation of ocular surface.The corneal epithelial defect,corneal turbidity and corneal neovascularization were observed and given clinical scores after the operations.Results:The human amniotic membrane seem to immune-privileged tissue and of ideal Biocompatibility.In subchronic toxicity test,statistics assay showed that there was no statistical significance between all targets of biological amnion group and negative control group.In the model of moderate acid burn in rabbit cornea,corneal opacity and neovascularization could easily be observed four month postoperatively of the control,while human amniotic membrane reconstructed corneal epithelium more effectively and reduced corneal haze and neovascularization.Conclusion:The results above prove that in this study the human amniotic membrane can't bring lymphocyte proliferation.The result of chronic systemic toxicity response through the subcutaneous implant 90 days can be seen that biological amnion is low immunogenicity and high security which is no difference with similar product.In the model of moderate acid burn in rabbit cornea,human amniotic membrane transplantation can effectively decrease corneal scarring and neovascularization.So it can be considered that biological amnion possess upper biologic security and biocompatibility.