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Recombinant Human Bone Morphogenetic Protein-2 as an Osteoinductive Biomaterial and a Biodegradable Carrier in a Rabbit Ulnar Defect Model

Institute for Drug Discovery Research, Yamanouchi Pharmaceutical Co., Ltd, 21 Miyukigaoka, Tsukuba, Ibaraki, 305-8585, Japan, satoshi.kokubo{at}jp.astellas.com

Kazutoshi Nozaki

Institute for Drug Discovery Research, Yamanouchi Pharmaceutical Co., Ltd, 21 Miyukigaoka, Tsukuba, Ibaraki, 305-8585, Japan

Shinji Fukushima

Institute for Drug Discovery Research, Yamanouchi Pharmaceutical Co., Ltd, 21 Miyukigaoka, Tsukuba, Ibaraki, 305-8585, Japan

Koichiro Takahashi

Institute for Drug Discovery Research, Yamanouchi Pharmaceutical Co., Ltd, 21 Miyukigaoka, Tsukuba, Ibaraki, 305-8585, Japan

Keiji Miyata

Institute for Drug Discovery Research, Yamanouchi Pharmaceutical Co., Ltd, 21 Miyukigaoka, Tsukuba, Ibaraki, 305-8585, Japan

Ryuhei Fujimoto

Institute for Drug Development Research, Yamanouchi Pharmaceutical Co., Ltd, 1-1-8 Azusawa, Itabashi-ku, Tokyo, 174-8511, Japan

Shoji Yokota

Institute for Drug Development Research, Yamanouchi Pharmaceutical Co., Ltd, 180 Ohzumi, Yaizu, Shizuoka, 425-0072, Japan

We investigated early local changes induced by recombinant human bone morphogenetic protein (rhBMP)-2 and a novel carrier, poly[L-lactide-co-glycolide] copolymer-coated gelatin sponge (PGS). A 1.5 cm segmental bone defect was created in the diaphysis of the right ulna of male Japanese white rabbit. Defects received PGS with or without rhBMP-2 (0, 0.4, or 1 mg/cm³) and were harvested at 3, 7, 14, 21, or 28 days post implantation for histological examination. Immuno-staining for vascular endothelial growth factor (VEGF) was also performed. Spindle-shaped cells were observed in the rhBMP-2-treated groups 3 and 7 days after implantation. Bone regeneration was detected after 14 days in the rhBMP-2-treated groups and the bone area increased with time and dose. Expression of VEGF was observed in all groups at 3 days and was maintained by 14 days only in the defects treated with rhBMP-2 at a dose of 1 mg. These results indicate that rhBMP-2 exert its osteo-inductive activities via the promotion of osteogenic cell mobilization, and possibly via angiogenesis based on VEGF induction. Foreign-body reactions to the implanted PGS were similar to those observed when either poly[L-lactide-co-glycolide] copolymer or gelatin was individually implanted. These results indicate that the PGS is a useful and safe carrier for rhBMP-2.

Key Words: rhBMP-2 • PLGA • gelatin sponge • rabbit • segmental bone defect • biodegradable carrier • recombinant human bone • morphogenetic protein-2 • osteoinductive biomaterial • rabbit ulnar • defect model.

Journal of Bioactive and Compatible Polymers, Vol. 23, No. 4, 348-366 (2008)
DOI: 10.1177/0883911508092791


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