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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.

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.