Evaluation of Pyrogen Test for Bone Marrow Mesenchymal Stem Cell-Sea Cucumber Skeleton Composite Scaffold
Objective:To conduct a pyrogen test on rabbit bone marrow mesenchymal stem cell(BMSC)composite sea cucumber skeleton bioscaffold and observe the febrile response in white rabbits,thereby assessing the safety of the composite scaffold implanted into living organisms based on changes in body temperature.Methods:Following the standards of"Biological Evaluation of Medical Devices,"this test in-volved selecting 3 healthy adult New Zealand white rabbits and slowly injecting the extract of the composite scaf-fold into the rabbits'ears via the marginal ear vein.The changes in body temperature before and after injection were compared.Results:The temperature increase in each New Zealand white rabbit was less than 0.6℃,and the total temperature increase in all three rabbits was 1.2℃,which is less than 1.4℃,meeting the require-ments of the pyrogen test.Conclusion:The bone marrow mesenchymal stem cell composite sea cucumber skele-ton bioscaffold does not contain significant pyrogenic substances and meets the safety standards for the applica-tion of biomaterials.
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维普
