Evaluation of biosafety of porous magnesium alloy scaffolds for jaw defects

doi:10.3969/j.issn.2095-4344.1736

Abstract

Abstract:

BACKGROUND: Biosafety and other advantages of biomedical magnesium alloy products have been confirmed, but the biosafety of porous scaffold materials prepared by changing the manufacturing process and product morphology based on the alloy composition is unclear.

OBJECTIVE: To investigate the biosafety properties of a biomedical porous magnesium alloy scaffold.

METHODS: Extracts of porous magnesium alloy scaffold materials were prepared, and in vitro cytotoxicity experiment, in vitro hemolysis experiment, intrauthelial reaction experiment, pyrogen experiment, acute systemic toxicity experiment and genetic toxicity experiment were conducted according to GB/T16886 biological evaluation series of medical devices. The effects of extracts of porous magnesium alloy scaffold materials on the activity of human bone marrow mesenchymal stem cells and the structural integrity of blood cell membrane, and the effects on the animal endothelial tissue, body temperature, body mass and chromosomal structure of polychromatic red blood cells were evaluated. Animal mandibular defect model was prepared, and porous magnesium alloy was implanted into the defect area to evaluate its influence on serum and urine Mg²⁺ concentration, blood cell number and important organs. The study was approved by the Experimental Animal Ethics Committee of Peking University Health Science Center (approval number: LA2017217).

RESULTS AND CONCLUSION: (1) The extracts of porous magnesium alloy scaffolds could promote the proliferation of bone marrow mesenchymal stem cells, and the cytotoxicity was 0. (2) The hemolysis rate of the extracts of porous magnesium alloy scaffold material was 0.94%, and the response to intradermal stimulation was 0, which met the requirements of medical device hemolysis experiment (< 5%) and intradermal reaction experiment (final score ≤ 1.0). (3) After the injection of porous magnesium alloy extract, the increased degree of body temperature was ≤ 0.4 ^oC and elevated total degree ≤ 0.8 ^oC in all animals, which conformed to the requirements of the medical equipment of heat experiment. (4) The porous magnesium alloy extract caused no systemic toxicity or damaged chromosomal structure of polychromatic erythrocytes. (5) Within 1 month after implantation of porous magnesium alloy scaffold material into the bone defect, there was no significant change in serum and urine Mg²⁺ concentration, the red blood cells, white blood cells and platelets were in the normal range, and no obvious pathological changes were found in the heart, liver, kidney and spleen tissues. (6) These results imply that porous magnesium alloy scaffold has excellent biosafety property.

Key words: magnesium alloy scaffold materials, porous magnesium alloy, biosafety, biodegradable, jaw defect, in vitro cytotoxicity experiment, hemolysis experiment, intrauthelial reaction experiment, pyrogen experiment, acute systemic toxicity experiment, genetic toxicity experiment

CLC Number:

Wang Liang, Guo Yuxing, Huang Hua, Yuan Guangyin, Zhang Lei. Evaluation of biosafety of porous magnesium alloy scaffolds for jaw defects[J]. Chinese Journal of Tissue Engineering Research, 2019, 23(26): 4121-4128.

Figures/Tables 11

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