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Biological Compatibility Profile on Biomaterials for Bone Regeneration
Published on: November 16, 2018
Preclinical evaluation of strontium-containing bioactive bone cement
Zhaoyang Li1, Ning Yuan, Raymond Wing Moon Lam
1School of Materials Science and Engineering, Tianjin University, Tianjin 300072, China; Tianjin Key Laboratory of Composite and Functional Materials, Tianjin 300072, China; Department of Orthopaedics and Traumatology, The University of Hong Kong, Hong Kong, China.
Summary
Strontium-containing bioactive bone cement (Sr-BC) shows promising preclinical safety for orthopaedic use. Studies confirm Sr-BC is non-toxic and non-genotoxic, with temporary inflammation resolving over time.
Area of Science:
- Biomaterials Science
- Orthopaedic Surgery
- Toxicology
Background:
- Strontium (Sr) stimulates bone formation and prevents bone loss, making it attractive for orthopaedic applications.
- A novel strontium-containing bioactive bone cement (Sr-BC) has been developed for treating osteoporotic bone fractures.
Purpose of the Study:
- To conduct a preclinical assessment of the biocompatibility and safety of Sr-BC according to ISO 10993 standards.
- To evaluate the potential toxicity and genotoxicity of Sr-BC for human implantation.
Main Methods:
- MTT assay for cytotoxicity on mouse fibroblasts.
- Genetic toxicity studies: Ames test, chromosome aberration assay, and bone marrow micronucleus assay.
- Muscle implantation study to assess tissue response and inflammation.
Main Results:
- MTT assay indicated Sr-BC is non-toxic to mouse fibroblasts, meeting basic orthopaedic implant requirements.
- Genetic toxicity assays demonstrated the absence of genotoxic components in Sr-BC.
- Muscle implantation showed acute inflammation at 1 week, which resolved by 12 weeks with no significant difference compared to controls.
Conclusions:
- Preclinical results provide assurance for the safety of Sr-BC.
- Sr-BC is a potential alternative to traditional bone cements for orthopaedic applications.
