Safety and efficacy of a new moldable and compression resistant matrix carrier with recombinant human bone morphogenetic protein-2 in the rabbit bone defect model

Abstract

AIM:Recombinant human bone morphogenetic protein-2 (rhBMP-2) was developed in the 1990s. We developed a new moldable and compression-resistant matrix (CRM) carrier. We conducted an animal experimental study to evaluate the safety and efficacy of the CRM carrier for rhBMP-2 in osteogenesis. MATERIAL and METHODS:New moldable CRM carrier, and with rhBMP-2 (new CRM carrier with rhBMP-2) were prepared as the experimental groups. Pre-existing synthetic bone graft material was prepared as a control graft group. A total of 24 rabbits were included in the study. Defects were made and grafts were performed, and radiographic and histopathologic findings were evaluated to assess fusion. RESULTS:In the computed tomographic scan, new bone formation was superior in 16.0%, 39.3%, 64.7%, and 81.1% of the total defect volume at 4, 8, 12, and 16 weeks in the new CRM carrier with rhBMP-2 group. In the new CRM carrier group, new bone formation was observed in 10.6%, 26.3%, 53.1%, and 71.4%, respectively. In the control graft group, new bone formation was observed in 10.1%, 26.6%, 53.4%, and 72.1%, respectively. On histopathologic evaluation, new CRM carrier with rhBMP-2 group showed better new bone formation compared with those of other groups. CONCLUSION:The new moldable CRM carrier and the CRM carrier with rhBMP-2 showed preclinical safety and efficacy in new bone formation. In particular, the CRM carrier with rhBMP-2 was considered to be an effective bone graft material for bone fusion.