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Research Articles

The toxicological effect of 4-week repeated intravenous injection of activin a/BMP-2 chimera and 2-week recovery study in Beagle dog*

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Pages 250-258 | Received 20 Oct 2017, Accepted 08 Jan 2019, Published online: 18 Mar 2019

References

  • Allendorph, G.P., et al., 2011. Designer TGFβ superfamily ligands with diversified functionality. PLoS One, 6 (11), e26402.
  • Benglis, D., Wang, M.Y., and Levi, A.D., 2008. A comprehensive review of the safety profile of bone morphogenetic protein in spine surgery. Neurosurgery, 62, ONS423–ONS431.
  • Boden, S.D., Schimandle, J.H., and Hutton, W.C., 1995. Lumbar intertransverse-process spinal arthrodesis with use of a bovine bone-derived osteoinductive protein. A preliminary report. The Journal of Bone and Joint Surgery. American Volume, 77 (9), 1404–1417.
  • Burkus, J.K., et al., 2002. Anterior lumbar interbody fusion using rhBMP-2 with tapered interbody cages. Journal of Spinal Disorders &Amp; Techniques, 15 (5), 337–349.
  • Burkus, J.K., et al., 2009. Six-year outcomes of anterior lumbar interbody arthrodesis with use of interbody fusion cages and recombinant human bone morphogenetic protein-2. The Journal of Bone and Joint Surgery. American Volume, 91 (5), 1181–1189.
  • Carragee, E.J., Hurwitz, E.L., and Weiner, B.K., 2011. A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: emerging safety concerns and lessons learned. The Spine Journal : Official Journal of the North American Spine Society, 11 (6), 471–491.
  • Crandall, D.G., et al., 2013. Transforaminal lumbar interbody fusion with rhBMP-2 in spinal deformity, spondylolisthesis, and degenerative disease–part 1: large series diagnosis related outcomes and complications with 2- to 9-year follow-up. Spine (Phila Pa 1976), 38 (13), 1128–1136.
  • Fu, R., et al., 2013. Effectiveness and harms of recombinant human bone morphogenetic protein-2 in spine fusion: a systematic review and meta-analysis. Annals of Internal Medicine, 158 (12), 890–902.
  • Gray, P.C., et al. 2000. Identification of a binding site on the type II activin receptor for activin and inhibin. The Journal of Biological Chemistry, 275 (5), 3206–3212.
  • Hoffmann, M.F., Jones, C.B., and Sietsema, D.L., 2016. Recombinant human bone morphogenetic protein-2 in posterolateral spinal fusion: what's the right dose? Asian Spine Journal, 10 (3), 457–464.
  • Joseph, V., and Rampersaud, Y.R., 2007. Heterotopic bone formation with the use of rhBMP2 in posterior minimal access interbody fusion: a CT analysis. Spine (Phila Pa 1976), 32 (25), 2885–2890.
  • Kim, R.Y., et al., 2014. The effect of dose on rhBMP-2 signaling, delivered via collagen sponge, on osteoclast activation and in vivo bone resorption. Biomaterials, 35 (6), 1869–1881.
  • Kim, H.J., et al. 2011. The effect of platelet rich plasma from bone marrow aspirate with added bone morphogenetic protein-2 on the Achilles tendon-bone junction in rabbits. Clinics in Orthopedic Surgery, 3 (4), 325–331.
  • Knox, J.B., Dai, J.M., 3rd., and Orchowski, J., 2011. Osteolysis in transforaminal lumbar interbody fusion with bone morphogenetic protein-2. Spine (Phila Pa 1976), 36 (8), 672–676.
  • Kusumoto, K., et al., 2002. Osteoinduction by recombinant human bone morphogenetic protein-2 in muscles of non-human primates. The Journal of International Medical Research, 30 (3), 251–259.
  • Lane, J.M., Tomin, E., and Bostrom, M.P., 1999. Biosynthetic bone grafting. Clin Orthop Relat Res, 367, S107–S117.
  • Lee, J.H., et al., 2015. Enhanced osteoinductivity of recombinant human bone morphogenetic protein-2 in combination with epidermal growth factor in a rabbit tibial defect model. Growth Factors, 33 (1), 31–39.
  • Lee, J.H., Choe, S., and Han, S., 2018. The cardiovascular effect of single injection and toxicologic effects of repetitive 2-week intravenous administration of activin A/BMP-2 chimera in Beagle dog. Cardiovascular Toxicology, 18 (1), 76–83.
  • Lee, J.H., et al., 2014a. Acute intravenous injection toxicity study of Escherichia coli-derived recombinant human bone morphogenetic protein-2 in rat. Asian Spine Journal, 8 (2), 113–118.
  • Lee, J.H., Lee, E.N., and Nam, S.H., 2014b. The short-term effects of repetitive E. coli-derived rhBMP-2 administration through intravenous injection in rats. Drug and Chemical Toxicology, 37 (1), 40–47.
  • Massague, J., and Weis-Garcia, F., 1996. Serine/threonine kinase receptors: mediators of transforming growth factor beta family signals. Cancer Surveys, 27, 41–64.
  • McKay, W.F., Peckham, S.M., and Badura, J.M., 2007. A comprehensive clinical review of recombinant human bone morphogenetic protein-2 (INFUSE Bone Graft). International Orthopaedics, 31 (6), 729–734.
  • Meisel, H.J., et al., 2008. Posterior lumbar interbody fusion using rhBMP-2. European Spine Journal : Official Publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 17 (12), 1735–1744.
  • Oh, C.S., et al., 2015. Bone transport for reconstruction in benign bone tumors. Clinics in Orthopedic Surgery, 7 (2), 248–253.
  • Okubo, Y., et al., 2000. Osteoinduction by bone morphogenetic protein-2 via adenoviral vector under transient immunosuppression. Biochemical and Biophysical Research Communications, 267 (1), 382–387.
  • Owens, K., et al., 2011. Perioperative complications with rhBMP-2 in transforaminal lumbar interbody fusion. European Spine Journal : Official Publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 20 (4), 612–617.
  • Slosar, P.J., Josey, R., and Reynolds, J., 2007. Accelerating lumbar fusions by combining rhBMP-2 with allograft bone: a prospective analysis of interbody fusion rates and clinical outcomes. The Spine Journal : Official Journal of the North American Spine Society, 7 (3), 301–307.
  • Smucker, J.D., et al., 2006. Increased swelling complications associated with off-label usage of rhBMP-2 in the anterior cervical spine. Spine (Phila Pa 1976), 31 (24), 2813–2819.
  • Tannoury, C.A., and An, H.S., 2014. Complications with the use of bone morphogenetic protein 2 (BMP-2) in spine surgery. The Spine Journal : Official Journal of the North American Spine Society, 14 (3), 552–559.
  • Yoon, B.H., et al., 2014. An activin A/BMP2 chimera, AB204, displays bone-healing properties superior to those of BMP2. Journal of Bone and Mineral Research : The Official Journal of the American Society for Bone and Mineral Research, 29 (9), 1950–1959.
  • Yoon, B.H., et al., 2016. The effects of a single intravenous injection of novel activin A/BMP-2 (AB204) on toxicity and the respiratory and central nervous systems. Drug and Chemical Toxicology, 39 (3), 284–289.
  • Yoon, B.H., et al., 2015. The toxicological evaluation of repetitive 2- and 4-week intravenous injection of Activin A/BMP-2 chimera (AB204) into rats. Regulatory Toxicology and Pharmacology : Rtp, 73 (1), 1–8.
  • Zheng, G.B., Yoon, B.H., and Lee, J.H., 2017. Comparison of the osteogenesis and fusion rates between activin A/BMP-2 chimera (AB204) and rhBMP-2 in a beagle's posterolateral lumbar spine model. Spine Journal,17 (10), 1529–1536
  • Zimmerman, C.M., and Mathews, L.S., 1996. Activin receptors: cellular signalling by receptor serine kinases. Biochemical Society Symposium, 62, 25–38.

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