title: Nonclinical assessment of tumor growth enhancement potential by B2A-coated ceramic granules used in arthodesis.
abstract: B2A is a synthetic peptide that augments osteodifferentiation and improves bony fusion when delivered on ceramic granules during arthrodesis surgery. Nonclinical safety assessments, including genotoxicity, supported the use of B2A-coated granules as a combination medical device in pilot clinical studies. As a prelude to pivotal clinical studies, an assessment of the possibility that B2A-coated granules (and B2A) could enhance tumor growth was undertaken. B2A-coated granules demonstrated no evidence of genotoxicity. Cell culture studies with human tumor cell lines demonstrated that neither exposure of cells to B2A or B2A-coated granules increased cell proliferation or invasive capability relative to controls. In vivo, surgically implanted B2A-coated granules did not increase tumor growth (4 human tumor cell lines) or metastasis (1 cell line) relative to vehicle controls in immune-compromised rodents. Thus, traditional genotoxicity, as well as specially designed tumor growth enhancement studies, indicates that the possibility of tumor enhancement appears unlikely.
authors: BioSurface Engineering Technologies, Inc, Rockville, MD 20850, USA. pzamora@biosetinc.com
authors: Paul O
authors: PO
authors: Zamora
authors: Xinhua
authors: X
authors: Lin
authors: Yi
authors: Y
authors: Liu
authors: Henry
authors: H
authors: Guo
mesh_terms: D000818:Animals; D001174:Arthrodesis; D045744:Cell Line, Tumor; D049109:Cell Proliferation; D002516:Ceramics; D004249:DNA Damage / Q000187:drug effects; D004195:Disease Models, Animal; D016503:Drug Delivery Systems / Q000379:methods*; D058750:Epithelial-Mesenchymal Transition; D006801:Humans; D008297:Male; D051379:Mice; D008807:Mice, Inbred BALB C; D009362:Neoplasm Metastasis / Q000188:drug therapy; D009369:Neoplasms / Q000473:pathology*; D010455:Peptides / Q000138:chemical synthesis* / Q000494:pharmacology*; D019736:Prostheses and Implants; D051381:Rats
chemical_list: D010455:Peptides