In Vivo Evaluation of Commercially Available Gel-Type Polyethylene Glycol Membrane for Carrier of Recombinant Human Bone Morphogenetic Protein-2

Abstract

PURPOSE: This study evaluated a commercially available, 3-dimensional gel-type polyethylene glycol (PEG) membrane as a carrier for recombinant human bone morphogenetic protein-2 (rhBMP-2) using a rat calvarial defect model. Another gel-type carrier, fibrin-fibronectin system (FFS), was used as a positive control.

MATERIALS AND METHODS: Critical-size defects were made in the rat calvarium, which were allocated to 1 of 10 groups comprising 2 healing periods and biomaterial conditions: 1) sham control, 2) FFS only, 3) FFS plus BMP-2, 4) PEG only, and 5) PEG plus BMP-2. Radiographic and histologic analyses were performed at 2 and 8 weeks after surgery.

RESULTS: After 2 weeks, some parts of the FFS were biodegraded and extensive cellular infiltration was observed at sites that received FFS or FFS plus BMP-2. The PEG membrane retained its augmented volume without cellular infiltration at sites that received PEG or PEG plus BMP-2. After 8 weeks, the FFS was completely degraded and replaced by new bone and connective tissues. In contrast, the volume of residual PEG was similar to that at 2 weeks, with slight cellular infiltration. In particular, there was progressive bone regeneration around micro-cracks and resorbed outer surface in the PEG + BMP-2 group. Although the PEG + BMP-2 group showed increased area and percentage of new bone, there was no statistical relevance after 2 and 8 weeks in histomorphometric analyses. However, the appearance of the healing differed (with new bone formation along micro-cracks in the PEG + BMP-2 group), and further studies with longer healing periods are needed to draw conclusions about clinical applications.

CONCLUSION: Evidence of mechanical stability and new bone formation along micro-cracks when using PEG plus BMP-2 might support the PEG membrane as a candidate carrier material for rhBMP-2.