title: Biocompatibility and inflammation profile of B2A-coated granules used in arthrodesis.
abstract: The biocompatibility/inflammation profile of B2A-coated ceramic granules was evaluated using a panel of standard biocompatibility protocols (International Organization for Standardization-10993) including skin irritation and delayed-type hypersensitivity (Kligman maximization test), as well as acute, subacute, and chronic toxicity. Additionally, the potential of B2A-coated granules to elicit inflammatory reactions was also assessed using in vivo air pouch models, and B2A was evaluated using in vitro models of leukocyte recruitment and endothelial cell activation. Overall, the findings demonstrate that B2A-coated ceramic granules exhibit good biocompatibility profiles in the murine air pouch model and in standard subcutaneous implant models, and B2A did not demonstrate evidence of leukocyte recruitment or endothelial cell activation. These findings suggest that B2A and B2A-coated granules have little, if any, propensity to initiate inflammation reactions based on leukocyte recruitment. Thus, traditional biocompatibility and specially designed inflammation models indicate a high degree of biocompatibility and a low possibility of toxicity, inflammation, or edema following the implant of B2A-coated granules.
authors: BioSurface Engineering Technologies, Inc., Rockville, MD 20850, USA. pzamora@biosetinc.com
authors: Paul O
authors: PO
authors: Zamora
authors: Yi
authors: Y
authors: Liu
authors: Henry
authors: H
authors: Guo
authors: Xinhua
authors: X
authors: Lin
mesh_terms: D000818:Animals; D001174:Arthrodesis; D002454:Cell Differentiation / Q000187:drug effects; D002516:Ceramics; D061307:Human Umbilical Vein Endothelial Cells / Q000166:cytology / Q000187:drug effects; D007249:Inflammation / Q000503:physiopathology; D018836:Inflammation Mediators / Q000378:metabolism; D007962:Leukocytes / Q000166:cytology / Q000187:drug effects; D008422:Materials Testing; D051379:Mice; D008807:Mice, Inbred BALB C; D010010:Osteoclasts / Q000166:cytology / Q000187:drug effects; D053244:Osteoprotegerin / Q000494:pharmacology; D010455:Peptides / Q000138:chemical synthesis* / Q000494:pharmacology*; D019736:Prostheses and Implants; D053245:RANK Ligand / Q000378:metabolism
chemical_list: D018836:Inflammation Mediators; D053244:Osteoprotegerin; D010455:Peptides; D053245:RANK Ligand