Li Jing, Ren Xiaoqi, Qiao Wei, Shi Hao, Yang Ting, Ma Shaoying, Li Baoxing, Zhao Yaping
Biomaterial R&D Center of China Institute for Radiation Protection, Shanxi Osteorad Biomaterial Co., Ltd, Taiyuan Shanxi, 030006, P. R. China.
Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2023 Mar 15;37(3):302-307. doi: 10.7507/1002-1892.202210022.
To prepare a new plastic bone filler material with adhesive carrier and matrix particles derived from human bone, and evaluate its safety and osteoinductive ability through animal tests.
The human long bones donated voluntarily were prepared into decalcified bone matrix (DBM) by crushing, cleaning, and demineralization, and then the DBM was prepared into bone matrix gelatin (BMG) by warm bath method, and the BMG and DBM were mixed to prepare the experimental group's plastic bone filler material; DBM was used as control group. Fifteen healthy male thymus-free nude mice aged 6-9 weeks were used to prepare intermuscular space between gluteus medius and gluteus maximus muscles, and all of them were implanted with experimental group materials. The animals were sacrificed at 1, 4, and 6 weeks after operation, and the ectopic osteogenic effect was evaluated by HE staining. Eight 9-month-old Japanese large-ear rabbits were selected to prepare 6-mm-diameter defects at the condyles of both hind legs, and the left and right sides were filled with the materials of the experimental group and the control group respectively. The animals were sacrificed at 12 and 26 weeks after operation, and the effect of bone defect repair were evaluated by Micro-CT and HE staining.
In ectopic osteogenesis experiment, HE staining showed that a large number of chondrocytes could be observed at 1 week after operation, and obvious newly formed cartilage tissue could be observed at 4 and 6 weeks after operation. For the rabbit condyle bone filling experiment, HE staining showed that at 12 weeks after operation, part of the materials were absorbed, and new cartilage could be observed in both experimental and control groups; at 26 weeks after operation, the most of the materials were absorbed, and large amount of new bone could be observed in the 2 groups, while new bone unit structure could be observed in the experimental group. Micro-CT observation showed that the bone formation rate and area of the experimental group were better than those of the control group. The measurement of bone morphometric parameters showed that the parameters at 26 weeks after operation in both groups were significantly higher than those at 12 weeks after operation ( <0.05). At 12 weeks after operation, the bone mineral density and bone volume fraction in the experimental group were significantly higher than those in the control group ( <0.05), and there was no significant difference between the two groups in trabecular thickness ( >0.05). At 26 weeks after operation, the bone mineral density of the experimental group was significantly higher than that of the control group ( <0.05). There was no significant difference in bone volume fraction and trabecular thickness between the two groups ( >0.05).
The new plastic bone filler material is an excellent bone filler material with good biosafety and osteoinductive activity.
制备一种含有人骨来源的黏附载体及基质颗粒的新型塑形骨填充材料，并通过动物实验评估其安全性及骨诱导能力。
将自愿捐献的人长骨经粉碎、清洗、脱矿后制成脱钙骨基质（DBM），再采用温水浴法将DBM制成骨基质明胶（BMG），将BMG与DBM混合制备实验组的塑形骨填充材料；以DBM作为对照组。选取15只6 - 9周龄健康雄性无胸腺裸鼠，制备臀中肌与臀大肌之间的肌间隙，均植入实验组材料。术后1、4、6周处死动物，通过HE染色评估异位成骨效果。选取8只9月龄日本大耳白兔，在双侧后肢髁部制备直径6 mm的骨缺损，左右侧分别填充实验组和对照组材料。术后12、26周处死动物，通过Micro - CT及HE染色评估骨缺损修复效果。
在异位成骨实验中，HE染色显示术后1周可见大量软骨细胞，术后4、6周可见明显的新生软骨组织。对于兔髁部骨填充实验，HE染色显示术后12周时，部分材料被吸收，实验组和对照组均可见新生软骨；术后26周时，大部分材料被吸收，两组均可见大量新生骨，而实验组可见新生骨单位结构。Micro - CT观察显示实验组的骨形成率及面积均优于对照组。骨形态计量学参数测量显示，两组术后26周时的参数均显著高于术后12周时的参数（<0.05）。术后12周时，实验组的骨密度及骨体积分数显著高于对照组（<0.05），两组在骨小梁厚度方面无显著差异（>0.05）。术后26周时，实验组的骨密度显著高于对照组（<0.05）。两组在骨体积分数及骨小梁厚度方面无显著差异（>0.05）。
新型塑形骨填充材料是一种具有良好生物安全性及骨诱导活性的优良骨填充材料。
