Poly(α-hydroxy acid) carrier for delivering recombinant human bone morphogenetic protein-2 for bone regeneration

Journal of Controlled Release

Volumn 39, Issue 2-3, 1996, Pages 287-304

  Hollinger, J ^a   Mayer, M ^a   Buck, D ^a   Zegzula, H ^a   Ron, E ^b   Smith, J ^c   Jin, L ^c   Wozney, J ^c  

^a OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^b Gel Sciences Inc   (United States)

^c PFIZER INC   (United States)

Author keywords

Bone repair; Poly( hydroxy acid); Recombinant human bone morphogenetic protein 2

Indexed keywords

BONE MORPHOGENETIC PROTEIN; CARRIER PROTEIN; POLY(2 HYDROXYACID); UNCLASSIFIED DRUG;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; AUTOGRAFT; BONE REGENERATION; BONE REMODELING; BONE TRANSPLANTATION; CONFERENCE PAPER; DOG; FRACTURE HEALING; HEALTH CARE QUALITY; MORBIDITY; NONHUMAN; PRIORITY JOURNAL; RABBIT; WOUND HEALING;

EID: 0029890008     PISSN: 01683659     EISSN: None     Source Type: Journal    
DOI: 10.1016/0168-3659(95)00183-2     Document Type: Conference Paper

References (73)

1. M.H. Mayer, Clinical perspectives on bone grafting: Avoiding the complications of developmental malformations, in: A.E. Seyfer and J.O. Hollinger (Eds), Bone Repair and Regeneration, W.B. Saunders, Philadelphia, Vol. 21, 1994, pp. 365-376.
2. J.M. Wozney, The bone morphogenetic protein family and osteogenesis, Mol. Reprod. Devel. 32 (1992) 160-167.
3. D. Kingsley, What do BMPs do in mammals? Clues from the mouse short-ear mutation, Trends Genet. 10 (1994) 16-21.
4. D.M. Kingsley, The TGF-beta superfamily: new members, new receptors and new genetic tests of function in different organisms, Genes Develop. 8 (1994) 133-146.
5. A.M. Reddi. Bone induction: Introduction and perspectives, in: A. Veis (Ed.), The Chemistry and Biology of Mineralized Connective Tissues, Elsevier/North-Holland, Amsterdam, 1981, pp. 593-596.
6. M. Urist, Bone morphogenetic protein, bone regeneration, heterotopic ossification and the bone-bone marrow consortium, in: W.A. Peck (Ed.), Bone and Mineral Research, Elsevier, New York, Vol. 6, 1989, pp. 57-112.
7. J.M. Wozney, V. Rosen, A.J. Celeste, L.M. Mitsock, M.J. Whittiers, R.W. Kriz, R.M. Hewick and E.A. Wang, Novel regulators of bone formation: molecular clones and activities, Science 242 (1988) 1528-1534.
8. P.P. Luyten, N.S. Cunningham, S. Ma, N. Muthukumaran. R.G. Hammonds, W.B. Nevins, W.I. Wood and A.H. Reddi, Purification and partial amino acid sequence of osteogenin, a protein initiating bone differentiation, J. Biol. Chem. 264 (1989) 13377-13380.
9. A.J. Celeste, J.A. Iannazzi, R.C. Taylor, R.M. Hewick. V. Rosen, E.A. Wang and J.M. Wozney, Identification of transforming growth factor-β family members present in bone-inductive protein purified from bovine bone, Proc. Natl. Acad. Sci. USA 87 (1990) 9843-9847.
10. E. Özkaynak, D.C. Rueger, E.A. Drier, C. Corbett, R.J. Ridge, T.K. Sampath and H. Oppermann, OP-1 cDNA encodes an osteogenic protein in the TGF-β family, EMBO J. 9 (1990) 2085-2093.
11. K.T. Sampath, J.E. Coughlin, R.M. Whetstone, D. Banach, C. Corbett, R.J. Ridge, E. Özkaynak, H. Opperman and D.C. Rueger, Bovine osteogenic protein is composed of dimers of OP-1 and BMP-2A, two members of the transforming growth factor-β super-family, J. Biol. Chem. 265 (1990) 13198-13205.
12. A.J. Celeste, R. Taylor, N. Yamaji, E. Wang, J. Ross and J. Wozney, Molecular clonging of BMP-8: Present in bovine bone which is highly related to BMP-5/6/7 sub-family of osteoinductive molecules, Keystone Conference 16F (1992) 100.
13. E. Özkaynak, P.N. Schnegelsberg, D.F. Jin, G.M. Clifford, F.D. Warren, E.A. Drier and H. Oppermann, Osteogenic protein-2. A new member of the transforming growth factor-beta superfamily expressed in early embryogenesis, J. Biol. Chem. 267 (1992) 25220-25227.
14. V. Rosen and S. Thies, The BMP proteins in bone formation and repair, Trends Genet. 8 (1992) 97-102.
15. A.J. Celeste, J.J. Song, K. Cox, V. Rosen and J.M. Wozney, Bone morphogenetic protein-9, a new member of the TGF-β superfamily, J. Bone Miner. Res. 9 (1994) S137.
16. D.M. Toriumi, H.S. Kotler, D.P. Luxunberg, M.E. Holtrop and E.A. Wang, Mandibular reconstruction with a recombinant bone-inducing factor. Functional, histological and biomechanical evaluation, Arch. Otolaryngol. Head Neck Surg. 117 (1991) 1101-1112.
17. A.W. Yasko, J.M. Lane, E.J. Fellinger, V. Rosen, J.M. Wozney and E.A. Wang, The healing of segmental bone defects induced by recombinant human bone morphogenetic protein (rhBMP-2), J. Bone Joint. Surg. 74-A (1992) 659-671.
18. T.N. Gerhart, C.A. Kirker-Head, M.J. Kriz, M.E. Holtrop, G.E. Hennig and E.A. Wang, Healing segmental femoral defects in sheep using recombinant human bone morphogenetic protein (rhBMP-2), Clin. Orthop. Rel. Res. 293 (1993) 317-326.
19. R. Kenley, K. Yim, J. Abrams, E. Ron, T. Turek, L. Marden and J. Hollinger, Biotechnology and bone graft substitutes, Pharm. Res. 10 (1993) 1393-1401.
20. S.D. Cook, G.C. Baffes, M.W. Wolfe, K. Sampath, D.C. Rueger and T.S. Whitecloud, The effect of human recombinant osteogenic protein-1 on healing of large segmental bone defects, J. Bone Joint Surg. 76A (1994) 827-838.
21. R. Kenley, L. Marden, T. Turek, L. Jin, E. Ron and J. Hollinger, Osseous regeneration in the rat calvarium using novel delivery systems for recombinant human bone morphogenetic protein-2 (rhBMP-2), J. Biomed. Mater. Res. 28 (1994) 1139-1147.
22. L.J. Marden, J.O. Hollinger, A. Chaudhari, T. Turek, R. Schaub and E. Ron, Recombinant bone morphogenetic protein-2 is superior to demineralized bone matrix in repairing craniotomies defects in rat, J. Biomed. Mater. Res. 28 (1994) 1127-1138.
23. E.A. Wang, V. Rosen. J.S. D'Alessandro, M. Bauduy, P. Cordes, T. Harada, D.I. Israel, R.M. Hewick. K.M. Kerns, P. LaPanet et al., Recombinant human bone morphogenetic protein induces bone formation, Proc. Natl. Acad. Sci. USA 87 (1990) 2220-2224.
24. J.O. Hollinger, Factors for osseous repair and delivery: Part I, J. Craniofac. Surg. 4 (1993) 115-121.
25. J.O. Hollinger, Factors for osseous repair and delivery: Part II, J. Craniofac. Surg. 4(1993) 135-141.
26. J.P. Schmitz and J.O. Hollinger, The critical sized defect as an experimental model for craniomandibulofacial nonunions, Clin. Orthop. Rel. Res. 205 (1986) 299-308.
27. J.O. Hollinger and J. Kleinschmidt, The critical size defect as an experimental model to test bone repair materials, J. Craniofac. Surg. 1 (1990) 60-68.
28. J.M, Wozney, Bone morphogenetic proteins, Prog. Growth Factors 1 (1989) 267-280.
29. E. Ron. R.G. Schaub and T. Turek, Formulations of blood-clot polymer matrix for delivery of osteogenic proteins, US Patent 5,171,579 (1992).
30. M.M. Mayer, J.O. Hollinger, E. Ron and J. Wozney, Repair of alveolar clefts in dogs with recombinant bone morphogenetic protein and poly(α-hydroxy acid), J. Plastic Reconstr. Surg. (1996) in press.
31. J.A. Key, The effect of local calcium depot on osteogenesis and healing of fractures, J. Bone Joint Surg. 16-A (1934) 176-184.
32. O.S. Nilsson, M.R. Urist, E.G. Dawson, T.P. Schmalzried and G.A.M. Finerman, Bone repair induced by bone morphogenetic protein in ulnar defects in dogs, J. Bone Joint Surg. 68-B (1986) 635-642.
33. W.F. Enneking, H. Burchardt, J.J. Fume and G. Piotrowski, Physical and Biological aspects of repair in dog cortical-bone transplants, J. Bone Joint Surg. 57-A (1975) 237-252.
34. J.B. Volpon, C.A.M. Xavier and R.P. Concalves, The use of decalcified granulated homologous cortical bone matrix in the correction of diaphyseal bone defects: an experimental study in rabbits, Arch. Orthop. Trauma. Surg. 99 (1982) 197-207.
35. J. Wittbjer. B. Palmer and K.G. Thorngren. Osteogenic properties of reimplanted decalcified and undecalcified autologous bone in the rabbit radius, Scand. J. Plast. Reconstr. Surg. 16 (1982) 239-244.
36. J. Wittbjer, B. Palmer. M. Rohlin and K.G. Thorngren, Osteogenic activity in composite grafts of demineralized compact bone and marrow, Clin. Orthop. Rel. Res. 173 (1982) 229-238.
37. C. Ben-fu and T. Xue-ming, Ultrastructural investigation of experimental non-union of fractures, Chin. Med. J. 99 (1986) 207-214.
38. P. Aspenberg, J. Wittbjer and K.G. Thorngren. Bone marrow matrix and marrow versus cancellous bone in rabbit radial defects, Arch. Orthop. Surg. 106 (1987) 335-340.
39. J. Guirai, L. Ferrández, J.M. Curto, J. Basora and P. Vicente, Carbon and polyester fibers as a scaffold for bone repair, Acta Orthop. Scand. 61 (1990) 16-20.
40. O.S. Nilsson and M.R. Urist. Immune inhibition of repair of canine skull trephine defects implanted with partially purified bone morphogenetic protein, Int. Orthop. 15 (1991) 752-757.
41. F.F. Nielsen, T. Karring and S. Gogolewski, Biodegradable guide for bone regeneration, Acta Orthop. Scand. 63 (1992) 66-69.
42. J.Y. Liu, D. Wang and H.H. Cheng, Use of revascularized periosteal allografts for repairing bony defects: An experimental study, Microsurgery 15 (1994) 93-97.
43. I. Masoud, F. Shapiro and A. Moses, Tibial epiphyseal development: A cross-sectional histologic and histomorphometric study in the New Zealand white rabbit, J. Orthop. Res. 4 (1986) 212-220.
44. I. Masoud, F. Shapiro and A. Moses, A longitudinal study of the growth of the New Zealand white rabbit: Cumulative and biweekly incremental growth rates for body length, body weight, femoral length and tibial length, J. Orthop. Res. 4 (1986) 221-231.
45. P.J. Boyne, Use of marrow-cancellous bone grafts in maxillary alveolar and palatal clefts, J. Dent. Res. 49 (1974) 821-824.
46. R.E. Marx, R.I. Miller, W.J. Ehler, G. Hubbard and T.I. Malinin. A comparison of particulate allogeneic and particulate autogenous bone grafts into maxillary alveolar clefts in dogs. J. Oral Maxillofac. Surg. 42 (1984) 3-9.
47. T.M. Graber. Orthodontics. Principles and Practice, W.B. Saunders, Philadelphia. 1968.
48. G. Jonsson and S. Stenstrom, Maxillary growth after palatal surgery. An experimental study in dogs, Scand. J. Plastic Reconstr. Surg. 12 (1978) 131-137.
49. N.S. Schachar, W.B. Henry. Jr, P.L. Wadsworth, W.W. Tomford, T.C. Fuller and H.J. Mankin, Immune response to massive osteoarticular allografts in a feline model, in: G. Friedlaender, H.J. Mankin and K.W. Sell (Eds), Osteochondral Allografts. Biology, Banking and Clinical Applications, Little, Brown and Co., Boston, 1981, pp. 81-102.
50. W.W. Tomford, R.J. Starkweather and M.H. Goldman, A study of the clinical incidence of infection in the use of banked allograft bone, J. Bone Joint Surg. 63 (1981) 244-248.
51. B.E. Buck and T.I. Malinin. Bone transplantation and human immunodeficency virus. An estimate of risk of acquired immunodeficiency syndrome (AIDS), Clin. Orthop. Rel. Res. (1989) 129-136.
52. B.E. Buck, L. Resnick and S.M. Shah, Human immunodeficiency virus cultured from human bone, Clin. Orthop. Rel. Res. 251 (1990) 249-252.
53. Center for Disease Control: Transmission of HIV through bone transplantation: Case report and public health recommendations, Morbid. Mortal. Weekly Rep. 37 (1988) 481-486.
54. A. Henricson, A. Hulth and O. Johnell, The occurence of accessory immunologic cells in bone induction, Clin. Orthop. Rel. Res. (1991) 270-277.
55. M.A. Asselmeier, R.B. Caspari and S. Bottenfield, A review of allograft processing and sterilization techniques and their role in transmission of the human immunodeficiency virus, Am. J. Sports Med. 21 (1993) 170-175.
56. Center for Disease Control Update: Mortality attributable to HIV infection/AIDS among persons aged 25-44 years -United States, 1990 and 1991, Morbid. Mortal. Weekly Rep. 42 (1993) 481-486.
57. J.A. Nemzek, S.P. Arnoczky and C.L. Swenson, Retroviral transmission by the transplantation of connective tissue allografts, J. Bone Joint Surg. 76-A (1994) 1036-1041.
58. M.R. Urist, Bone: formation by autoinduction, Science 150 (1965) 893-899.
59. M.R. Urist, M.F. Silverman, K. Buring, F.L. Dubuc and J.M. Rosenburg, The bone induction principle, Clin. Orthop. 53 (1967) 243.
60. M.R. Urist and B.S. Strates, Bone morphogenetic protein, J. Dent. Res. 50 (1971) 1392-1406.
61. T.N. Gerhart, C.A. Kirker-Head, M.J. Kriz, J.A. Hipp, S. Schelling, J.M. Wozney and E.A. Wang, Healing segmental femoral defects in sheep using recombinant human bone morphogenetic protein (rhBMP-2), Trans. Orthop. Res. Soc. 16 (1991) 172.
62. J.D. Cook, G.C. Baffes, M.W. Wolfe, T.K. Sampath and D.C. Rueger, Recombinant human bone morphogentic protein-7 induces healing in a canine long-bone segmental defect model, Clin. Orthop. 301 (1994) 302-312.
63. J.D. Cook, M.W. Wolfe, S.L. Salkeld and D.C. Rueger, Effect of recombinant human osteogenic protein-1 on healing of segmental defects in non-human primates, J. Bone Joint Surg. 177A (1995) 734-750.
64. L.R. Ellingsworth, F. DeLustro, J.E. Brennan, S. Sawamura and J. McPherson, The human immune response to reconstituted bovine collagen, J. Immunol. 136 (1986) 877-882.
65. F. DeLustro, J. Dasch, J. Keefe and L. Ellingsworth, Immune responses to allogeneic and xenogeneic implants of collagen and collagen derivatives, Clin. Orthop. 260 (1990) 263-279.
66. M.J.A. van Luyn, P.B. van Wachem, L.H.H. Olde Damink, P.J. Dikstra, J. Feijen and P. Nieuwenhuis, Secondary cytotoxicity of cross-linked dermal sheep collagens during repeated exposure to human fibroblasts, Biomaterials 13 (1992) 1017-1024.
67. C.C. Chu, The degradation and biocompatibility of suture materials, in: D.F. Williams (Ed.), CRC Critical Reviews in Biocompatibility, CRC Press, Boca Raton, FL, Vol. 1, 1985, pp. 261-322.
68. J.O. Hollinger and G.C. Battistone, Biodegradable bone repair materials7 Synthetic polymers and ceramics, Clin. Orthop. Rel. Res. 207 (1986) 290-305.
69. O.M. Bostman, Current concepts review, absorbable implants for the fixation of fractures, J. Bone Joint Surg. 73-A (1991) 148-152.
70. O. Bostman, E. Hirvensalo, J. Makinen and P. Rokkanen, Foreign-body reactions to fracture fixation implants of biodegradable synthetic polymers, J. Bone Joint Surg. (1990) 72-B: 592-6.
71. O. Bostman, Absorbable implants for fixation of fractures, J. Bone Joint Surg. (1991) 73A: 148-153.
72. O. Bostman, U. Paivarinta, E. Patio, M. Manninen, A. Majola, J. Vesenius and P. Rokkanen, Absorbable polyglycolide screws in internal fixation of femoral osteotomies in rabbits, Acta Orthop. Scand. 62 (1991) 587-591.
73. E.J. Bergsma, F.R. Rozema, R.R.M. Bos and W.C. De Bruijn, Foreign body reactions to resorbable poly(L-lactide) bone plates and screws used for fixation of unstable zygomatic fractures. J. Oral Maxillofac. Surg. 51 (1993) 666-670.