Ectopic bone formation via rhBMP-2 delivery from porous bioabsorbable polymer scaffolds.

Drug delivery devices have received considerable interest in the field of tissue engineering due to the advent of proteins that can induce proliferation and differentiation of various cells to form specific tissues and organs, for example, bone morphogenetic protein (BMP-2) for osteogenesis. In this work the delivery of a clinically relevant bioactive factor, recombinant human rhBMP-2, was tested in vivo in a rat ectopic bone induction assay. Contact radiography and radiomorphometry showed significantly more radiopacity (1798+/-183 mm2 versus. 784+/-570 mm2 radiopaque area/g scaffold) in the BMP scaffolds than controls (p < 0.002). De novo woven bone and abundant osteoid formation were confirmed from histological sections while controls contained minimal amounts of tissue. Histomorphometry revealed significantly more bone (124+/-93 mm2 versus 7+/-12 mm2) and osteoid (72+/-43 mm2 versus 20+/-21 mm2) in the BMP implants (p < 0.001). These scaffolds demonstrated the ability to deliver viable rhBMP-2 and to induce bone formation in an ectopic site.