Safety of recombinant human platelet-derived growth factor-BB in Augment® bone graft

Journal of Tissue Engineering

Volumn 3, Issue 1, 2012, Pages 1-6

  Solchaga, Luis A ^a   Hee, Christopher K ^a   Roach, Stephen ^a   Snel, Leo B ^a  

^a BioMimetic Therapeutics Inc   (United States)

Author keywords

Arthrodesis rhPDGF BB; Bone graft substitute; Bone repair; Platelet derived growth factor; Safety

Indexed keywords

BONE; REPAIR; SAFETY FACTOR; TUMORS;

ARTHRODESIS; ARTHRODESIS RHPDGF-BB; BONE GRAFT; BONE GRAFT SUBSTITUTES; BONE REPAIR; CHRONIC TOXICITY; CLINICAL DATA; HINDFOOT; PLATELET-DERIVED GROWTH FACTORS; TUMOR PROMOTION;

TOXICITY;

EID: 84884491059     PISSN: None     EISSN: 20417314     Source Type: Journal    
DOI: 10.1177/2041731412442668     Document Type: Article

References (32)

1. Heldin C-H. Platelet-derived growth factor-an introduction. Cytokine Growth Factor Rev 2004; 15: 195-196.
2. Hollinger JO, Hart CE, Hirsch SN, et al. Recombinant human platelet-derived growth factor: biology and clinical applications. J Bone Joint Surg Am 2008; 90: 48-54.
3. Caplan A and Correa D. PDGF in bone formation and regeneration: new insights into a novel mechanism involving MSCs. J Orthop Res 2011; 29(12): 1795-1803.
4. Hollinger JO, Onikepe AO, Mackrell J, et al. Accelerated fracture healing in the geriatric, osteoporotic rat with recombinant human platelet-derived growth factor-BB and an injectable beta-tricalcium phosphate/collagen matrix. J Orthop Res 2007; 26: 83-90
5. Al-Zube L, Breitbart EA, O'Connor JP, et al. Recombinant human platelet-derived growth factor BB (rhPDGF-BB) and beta-tricalcium phosphate/collagen matrix enhance fracture healing in a diabetic rat model. J Orthop Res 2009; 27: 1074-1081.
6. Moore DC, Ehrlich MG, McAllister SC, et al. Recombinant human platelet-derived growth factor-BB augmentation of new-bone formation in a rat model of distraction osteogenesis. J Bone Joint Surg Am 2009; 91: 1973-1984.
7. Solchaga LA, Hee CK, Aguiar DJ, et al. AugmentR Bone Graft products compare favorably to autologous bone graft in an ovine model of lumbar interbody spine fusion. Spine. 2012; 37(8): 1-7.
8. Nevins M, Giannobile WV, McGuire MK, et al. Plateletderived growth factor stimulates bone fill and rate of attachment level gain: results of a large multicenter randomized controlled trial. J Periodontol 2005; 76: 2205-2215.
9. Kaigler D, Avila G, Wisner-Lynch L, et al. Platelet-derived growth factor applications in periodontal and peri-implant bone regeneration. Expert Opin Biol Ther 2011; 11: 1-11.
10. Daniels T, DiGiovanni C, Lau J, et al. Prospective clinical pilot trial in a single cohort group of rhPDGF in foot arthrodeses. Foot Ankle Int 2010; 31: 473-479.
11. Graham S, Leonidou A, Lester M, et al. Investigating the role of PDGF as a potential drug therapy in bone formation and fracture healing. Expert Opin Investig Drugs 2009; 18: 1633-1654.
12. Digiovanni CW, Baumhauer J, Lin SS, et al. Prospective, randomized, multi-center feasibility trial of rhPDGF-BB versus autologous bone graft in a foot and ankle fusion model. Foot Ankle Int 2011; 32: 344-354.
13. Mantur M, Snarska J, Sidorska A, et al. Changes in PDGF concentration in surgically treated colorectal carcinoma. Adv Med Sci 2008; 53: 37-41.
14. Yu J, Ustach C, Kim HR. Platelet-derived growth factor signaling and human cancer. J Biochem Mol Biol 2003; 36: 49-59.
15. Young CS, Bradica G, Hart CE, et al. Preclinical toxicology studies of recombinant human platelet-derived growth factor-bb either alone or in combination with beta-tricalcium phosphate and type I collagen. Journal Tissue Eng 2011; 2010: 246215.
16. Young CS, Ladd PA, Browning CF, et al. Release, biological potency, and biochemical integrity of recombinant human platelet-derived growth factor-BB (rhPDGF-BB) combined with augment™ bone graft or GEM 21S betatricalcium phosphate (beta-TCP). J Control Release 2009; 140: 250-255.
17. Bowen-Pope DF. Platelet-derived growth factor in vivo: levels, activity, and rate of clearance. Blood 1984; 64: 458-469.
18. Raines EW, Bowen-Pope DF, Ross R. Plasma binding proteins for platelet-derived growth factor that inhibit its binding to cell-surface receptors. Proc Natl Acad Sci USA 1984; 81: 3424-3428.
19. Huang JS, Huang SS, Deuel TF. Specific covalent binding of platelet-derived growth factor to human plasma alpha 2-macroglobulin. Proc Natl Acad Sci USA 1984; 81: 342-346.
20. Crookston KP, Webb DJ, Lamarre J, et al. Binding of platelet-derived growth factor-BB and transforming growth factor-beta 1 to alpha 2-macroglobulin in vitro and in vivo: comparison of receptor-recognized and non-recognized alpha 2-macroglobulin conformations. Biochem J 1993; 293: 443-450.
21. Bonner JC, Badgett A, Hoffman M, et al. Inhibition of platelet- derived growth factor-BB-induced fibroblast proliferation by plasmin-activated alpha 2-macroglobulin is mediated via an alpha 2-macroglobulin receptor/low density lipoprotein receptor-related protein-dependent mechanism. J Biol Chem 1995; 270: 6389-6395.
22. Bonner JC. Regulation of platelet-derived growth factor (PDGF) and alveolar macrophage-derived PDGF by alpha 2-macroglobulin. Ann NY Acad Sci 1994; 737: 324-338.
23. Doolittle RF, Hunkapiller MW, Hood LE, et al. Simian sarcoma virus onc gene, v-sis, is derived from the gene (or genes) encoding a platelet-derived growth factor. Science 1983; 221: 275-277.
24. Waterfield MD, Scrace GT, Whittle N, et al. Platelet-derived growth factor is structurally related to the putative transforming protein p28sis of simian sarcoma virus. Nature 1983; 304: 35-39.
25. Berlanga-Acosta J, Gavilondo-Cowley J, del Barco-Herrera DG, et al. Epidermal growth factor (EGF) and plateletderived growth factor (PDGF) as tissue healing agents: clarifying concerns about their possible role in malignant transformation and tumor progression. J Carc Mutagen 2011; 1:115. doi:10.4172/2157-518.1000115.
26. Heldin C-H and Westermark B. Mechanism of action and in vivo role of platelet-derived growth factor. Physiol Rev 1999; 79: 1283-1316.
27. Johnsson A, Betsholtz C, Heldin CH, et al. Antibodies against platelet-derived growth factor inhibit acute transformation by simian sarcoma virus. Nature 1985; 317: 438-440.
28. Betsholtz C, Johnsson A, Heldin CH, et al. Efficient reversion of simian sarcoma virus-transformation and inhibition of growth factor-induced mitogenesis by suramin. Proc Natl Acad Sci USA 1986; 83: 6440-6444.
29. Shih AH, Dai C, Hu X, et al. Dose-dependent effects of platelet-derived growth factor-B on glial tumorigenesis. Cancer Res 2004; 64: 4783-4789.
30. Calzolari F, Appolloni I, Tutucci E, et al. Tumor progression and oncogene addiction in a PDGF-B-induced model of gliomagenesis. Neoplasia 2008; 10: 1373-1382.
31. Croce CM. Oncogenes and cancer. N Engl J Med 2008; 358: 502-511.
32. Ziyadeh N, Fife D, Walker AM, et al. A matched cohort study of the risk of cancer in users of becaplermin. Adv Skin Wound Care 2011; 24: 31-39.