Abstract:

BACKGROUND: There are many studies about biological effect of nanotopography, but the research of safety evaluation of nanotopography has not been reported.
OBJECTIVE: To evaluate the biocompatibility of new nanotopography.
METHODS: The experiments of systemic toxicity, irritation and sensitization, and acute hemolysis of nanotopography were performed in Kunming mice, New Zealand rabbits and human according to “GB/T_16886”. The morphology and proliferation of rabbit bone marrow mesenchymal stem cells cultured on nanotopography were observed.
RESULTS AND CONCLUSION: All test animals were alive. Acute toxicity: there was no significant difference in weight before and after experiment. Tests for irritation and sensitization: there were no erythema or fester on surfaces of test animals, and the difference between the experimental group and control group was significant. Acute hemolysis: hemolytic reaction could not be observed in the experimental group, and hemolytic rate was less than 5% according to absorbance. Well cell morphology and adhesion of bone marrow mesenchymal stem cells cultured on nanotopography were observed by experiments in vitro, and cell proliferation at 1 day was increased compared with that at 3 days. All the results suggested that nanotopography is no-biotoxicity and has a good biocompatibility. Therefore, it can be used as orthopedic substitute implant in clinic. However, its long-term effect of biotoxicity needs to be evaluated.