Regeneration of a Rabbit Segmental Defect with a New Bone Therapy: Autologous Blood Coagulum with Bone Morphogenetic Protein 6 and Synthetic Ceramics.

Segmental defects of long bones are among the most challenging and debilitating conditions in clinical medicine. Osteogrow-C is a novel osteoinductive device composed of recombinant human bone morphogenetic protein 6 (rhBMP6) delivered within autologous blood coagulum (ABC) with calcium phosphate ceramics that was proven efficacious in preclinical models of spinal fusion. This study aimed to evaluate the efficacy of Osteogrow-C in comparison to that of other osteoinductive therapies in a clinically relevant segmental defect model in rabbits. Segmental defects (15 mm) of rabbit ulna were treated with Osteogrow-C containing different synthetic ceramic particles (tricalcium phosphate [TCP] and TCP/hydroxyapatite 40%/60%), Osteogrow (rhBMP6/ABC), Infuse (rhBMP2/absorbable collagen sponge), and control implants without bone morphogenetic proteins. Defect healing was evaluated by in vivo x-ray scans 4, 8, and 17 weeks after the surgery, and animals were killed after 17 weeks for further radiographical and histological assessment. Evaluation of x-ray images, micro-computed tomography, and histological sections revealed that both Osteogrow-C formulations as well as Osteogrow and Infuse promoted healing of the ulnar segmental defect. However, radiographic scores were higher in animals treated with Osteogrow-C than those for the other used therapies. Moreover, evaluation of in vivo x-ray scans revealed that Osteogrow-C with TCP ceramics induced the most rapid defect bridging. On the other hand, control implants (ABC/TCP and ABC/biphasic calcium phosphate) promoted limited osteogenesis without defect bridging. The findings of this study suggest that Osteogrow-C is a promising safe therapeutic solution for the treatment of large bone defects, providing relief to millions of patients suffering from this debilitating condition.