Experimental study on the biocompatibility and security of a rhBMP-2 loaded amorphous calcium phosphate delayed release nano-sized material / 中国矫形外科杂志

ABSTRACT

[Objective]To study the biocompatibility and security of the recombinant human bone morphogenetic protein-2(rhBMP-2) loaded amorphous calcium phosphate(ACP) delayed release nano-sized material and investigate the feasibility of the clinical use as a kind of bone substitute in bone engineering.[Method]The in vitro hemolyzation,cytotoxicity,microkernel test in marrow smear,acute systemic toxicity,pyrogenicity,subcuticular stimulation reaction and short-term intramuscular implantation,as well as endosseous implantation were performed on the rhBMP-2/ACP delayed release nano-sized material.[Result]The material-extracted liquid induced no hemolyzation,no toxic effects of genetic,no pyrogenic reaction in rabbits,no cytotoxicity cultured in rabbit bone marrow-derived mesenchymal stem cells(BMSCs) in vitro and no acute toxicity in mice.The intramuscular implantation and endosseous implantation in rabbits induced no inflammatory reaction,tissue necrosis and the material was degraded gradually,fused organically with tissues.[Conclusion]The biocompatibility and security of the rhBMP-2/ACP delayed release nano-sized material could meet the requirements given in biological standards for implanted biomaterials ISO10993 and GB/T16886,suggesting that it could be a good bone substitution for the clinical trial.