Abstract
Background:
Current therapies to effectively treat long-bone defects and extensive bone tissue loss remains limited. In this study, we created a new bone substitute by integrating advanced technologies such as structure patterning, controlled release of a bone growth factor and conjugation system for clinically effective bone regeneration. This novel bioactive bone substitute was evaluated for its safety and efficacy using a rabbit ulna model.
Methods:
A three dimensional bone patterned cylindrical structure with 1.5 cm in length and 5 mm in diameter was printed using poly(L-lactic acid)(PLLA) as a weight-bearing support and space-filling scaffold. And a bone morphogenetic protein 2 (BMP2) was employed to enhance bone regeneration, and coated to a 3D PLLA using alginate catechol and collagen to prolong the release kinetics. This novel bone substitute (BS)was evaluated for its physico-chemical and biological properties in vitro, and histological analysis and radiographical analysis such as X-ray, CT and micro-CT image analysis were performed to evaluate new bone formation in vivo.
Results:
The BS possesses an ideal shape and mechanically suitable proeperties for clinical use, with an easy-to-grab and break-resistant design at both ends, 80 ± 10 MPa of compression strength, and BMP2 release for two months. Histological analysis demonstrated the biocompability of BS with minimal inflammation and immune response, and X-ray, CT and micro-CT demonstrated effective new bone formation in rabbit ulna defect model.
Conclusion:
The preclinical study of a novel bioactive bone substitute has shown its safe and effective properties in an animal model suggesting its clinical potential.
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Data availability
The data presented in this study are available on request from all the authors.
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Acknowledgements
This research was supported by the Korean Fund for Regenerative Medicine funded by the Ministry of Science and ICT and by the Ministry of Health and Welfare (21C0705L1-11). We thank Enago for professional English language editing.
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JOL and C-WO conceived of the study. YRH, T-HK, KL, JOL, and C-WO wrote the manuscript. YRH and T-HK performed experiments.
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Animal experiments were performed in accordance with the guidelines approved by KMEDI-hub (IACUC Approval no. KMEDI-22052302-01).
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Hong, Y.R., Kim, TH., Lee, K. et al. Bioactive Bone Substitute in a Rabbit Ulna Model: Preclinical Study. Tissue Eng Regen Med 20, 1205–1217 (2023). https://doi.org/10.1007/s13770-023-00591-4
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DOI: https://doi.org/10.1007/s13770-023-00591-4