Segmental mandibular bone reconstruction with a carbonate‐substituted hydroxyapatite‐coated modular endoprosthetic poly(ɛ‐caprolactone) scaffold in Macaca fascicularis

A bio‐degradable scaffold incorporating osteoinductive factors is one of the alternative methods for achieving the regeneration of a mandibular bone defect. The current pilot study addressed such a bone reconstruction in a non‐human primate model, Macaca fascicularis monkeys, with an engineered poly(ɛ‐caprolactone) (PCL) scaffold, provided with a carbonate‐substituted hydroxyapatite coating. The scaffolds were implanted into unilaterally created mandibular segmental defects in 24 monkeys. Three experimental groups were formed: (1) scaffolds with rhBMP‐2 ( n = 8), (2) scaffolds with autologous mixed bone marrow cells ( n = 8), and (3) empty scaffolds as a control group ( n = 8). Evaluation was based on clinical observation as well as micro‐CT, mechanical, and histological analyses. Despite a high infection rate, the overall results showed that the currently designed PCL scaffolds had insufficient load‐bearing capability, and complete bone union was not achieved after 6 months of implantation. Nevertheless, the group of PCL scaffolds loaded with rhBMP‐2 showed evidence of bone‐regenerative potential, in contrast to PCL with autologous mixed bone marrow cells and the control group. © 2013 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 102B: 962–976, 2014.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/107529/1/jbmb33077.pd