Clinical need for bone morphogenetic proteins

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Jun 29, 2017 - morphogenetic proteins for bone healing^ summarizing and interpreting ... those published in International Orthopaedics [2–8]. For ex- ample ...
International Orthopaedics (SICOT) (2017) 41:2415–2416 DOI 10.1007/s00264-017-3550-y

LETTER TO THE EDITOR

Clinical need for bone morphogenetic proteins Slobodan Vukičević 1 & Lovorka Grgurević 1 & Marko Pećina 2

Received: 19 June 2017 / Accepted: 19 June 2017 / Published online: 29 June 2017 # SICOT aisbl 2017

Krishnakumar et al. [1] recently published a systemic review in International Orthopaedics on BClinical application of bone morphogenetic proteins for bone healing^ summarizing and interpreting findings from clinical studies on BMP use in fractures, non-unions and osteonecrosis (published 2000–2016; level of evidence I to IV). Surprisingly, the selection of articles for some reason missed several clinical studies and case reports including those published in International Orthopaedics [2–8]. For example, Das et al. [2] published the first randomized controlled clinical trial of 20 patients with Congenital Pseudarthrosis of the Tibia (CPT) associated with neurofibromatosis type I using rhBMP-7, an important indication recently approved for clinical testing by FDA using rhBMP-2 [9]. Instead, authors have preferably chosen manuscripts published in other journal supplements [1] decreasing thus the data source for appropriate conclusions. In the introduction, the authors claim that the discovery of BMPs by Urist took place at the end of the 19th century, referring to an unrelated journal supplement [10]; avoiding thus the quotation of the original discovery of BMPs published by Urist in 1965 [11] and recently acknowledged in International Orthopaedics in the orthopaedic heritage section as a tribute to Marshall Urist [12].

Consistently in this review [1], the authors referred to BMP preclinical studies with scaffolds unrelated to those superseding RCTs used for marketing approval of rhBMP-2 and rhBMP-7 based products. Under BComplications^ the authors discussed issues related to spinal surgery although their literature search did not include the use of BMPs in spinal fusion clinical studies systemically reviewed elsewhere [13, 14]. Finally, the conclusion is again based on the clinical use of BMPs in fractures, nonunions and osteonecrosis ascribing potential controversies to the heterogeneity of published studies. The authors also missed the systemic review on the clinical use of rhBMPs and the quality of RCTs suggesting that obtained results were not primarily heterogeneic [1], but in spine RCTs associated with side effects like cancer, which were mainly not reported although statistically insignificant [13–15]. Compliance with ethical standards Conflict of interest MP declares no conflict of interest. LG is actively involved in the development and clinical testing of Osteogrow, a new BMP6 therapeutic implant for bone regeneration. SV is the founder of Genera Research, a Croatian biotechnology company conducting clinical trials with Osteogrow.

References * Slobodan Vukičević [email protected]

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Laboratory for Mineralized Tissues, Center of Excellence for Reproductive and Regenerative Medicine, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Salata 11, 10000 Zagreb, Croatia Department of Orthopaedic Surgery, School of Medicine University of Zagreb, 10000 Zagreb, Croatia

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Krishnakumar GS, Roffi A, Reale D, Kon E, Filardo G (2017) Clinical application of bone morphogenetic proteins for bone healing: a systemic review. Int Orthop 41:1073–1083 Das SP, Ganesh S, Pradhan S, Singh D, Mohanty RN (2014) Effectiveness of recombinant human bone morphogenetic protein7 in the management of congenital pseudoarthrosis of the tibia: a randomised controlled trial. Int Orthop 38:1987–1992 Pecina M, Vukicevic S (2007) Biological regeneration of bone, cartilage and tendon. Int Orthop 31(6):719–720

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International Orthopaedics (SICOT) (2017) 41:2415–2416 Pecina M, Vukicevic S (2014) Tissue engineering and regenerative orthopaedics (TERO). Int Orthop 38(9):1757–1760 Bishop GB, Einhorn TA (2007) Current and future clinical applications of bone morphogenetic proteins in orthopaedic trauma surgery. Int Orthop 31:721–727 White AP, Vaccaro AR, Hall JA, Whang PG, Friel BC, McKee MD (2007) Clinical applications of BMP-7/OP-1 in fractures, nonunions and spinal fusion. Int Orthop 31:735–741 Bilic R, Simic P, Jelic M, Stern-Padovan R, Dodig D, van Meerdervoort HP, Martinovic S, Ivankovic D, Pecina M, Vukicevic S (2006) Osteogenic protein-1 (BMP-7) accelerates healing of scaphoid non-union with proximal pole sclerosis. Int Orthop 30:128–134 Dumic Cule I, Pecina M, Jelic M, Jankolija M, Popek I, Grgurevic L, Vukicevic S (2015) Biological aspects of segmental bone defect management. Int Orthop 39:1005–1011 Korf B (2017) A study of INFUSE bone graft (BMP-2) in the treatment of tibial pseudarthrosis in neurofibromatosis type 1 (NF1) (NF107-BMP2). https://clinicaltrials.gov/ct2/show/ NCT02718131. Accessed 26 Juni 2017 Dimitriou R, Giannoudis PV (2005) Discovery and development of BMPs. Injury 36(Suppl 3):S28–S33

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Urist MR (1965) Bone: formation by autoinduction. Science 150: 893–899 Grgurevic L, Pecina M, Vukicevic S (2017) Marshall R. Urist and the discovery of bone morphogenetic proteins. Int Orthop 41:1065– 1069 Fu R, Selph S, McDonagh M, Peterson K, Tiwari A, Chou R, Helfand M (2013) Effectiveness and harms of recombinant human bone morphogenetic protein-2 in spine fusion: a systematic review and meta-analysis. Ann Intern Med 158:890–902 Simmonds MC, Brown JV, Heirs MK, Higgins JP, Mannion RJ, Rodgers MA, Stewart LA (2013) Safety and effectiveness of recombinant human bone morphogenetic protein-2 for spinal fusion: a meta-analysis of individual-participant data. Ann Intern Med 158: 877–889 Vukicevic S, Oppermann H, Verbanac D, Jankolija M, Popek I, Curak J, Brkljacic J, Pauk M, Erjavec I, Francetic I, Dumic-Cule I, Jelic M, Durdevic D, Vlahovic T, Novak R, Kufner V, Bordukalo Niksic T, Kozlovic M, Banic Tomisic Z, Bubic-Spoljar J, Bastalic I, Vikic-Topic S, Peric M, Pecina M, Grgurevic L (2014) The clinical use of bone morphogenetic proteins revisited: a novel biocompatible carrier device OSTEOGROW for bone healing. Int Orthop 38: 635–647