Recombinant Human BMP6 Applied Within Autologous Blood Coagulum Accelerates Bone Healing: Randomized Controlled Trial in High Tibial Osteotomy Patients.

Autor: Chiari C; Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria., Grgurevic L; Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Zagreb, Croatia., Bordukalo-Niksic T; Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Zagreb, Croatia., Oppermann H; Genera Research, Rakov Potok, Croatia., Valentinitsch A; Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria., Nemecek E; Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria., Staats K; Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria., Schreiner M; Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria., Trost C; Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria., Kolb A; Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria., Kainberger F; Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria., Pehar S; Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Zagreb, Croatia., Milosevic M; Department of Environmental and Occupational Health and Sports, School of Public Health, 'Andrija Stampar,', University of Zagreb School of Medicine, Zagreb, Croatia., Martinovic S; SmartMedico, Zagreb, Croatia., Peric M; Department for Intracellular Communication, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Zagreb, Croatia., Sampath TK; perForm Biologics Inc., Holliston, MA, USA., Vukicevic S; Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Zagreb, Croatia., Windhager R; Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria.
Jazyk: angličtina
Zdroj: Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research [J Bone Miner Res] 2020 Oct; Vol. 35 (10), pp. 1893-1903. Date of Electronic Publication: 2020 Jul 02.
DOI: 10.1002/jbmr.4107
Abstrakt: Bone morphogenetic proteins (BMPs) are potent osteogenic proteins that induce new bone formation in vivo. However, their effect on bone healing in the trabecular bone surfaces remains challenging. We evaluated the safety and efficacy of recombinant human BMP6 (rhBMP6) applied within an autologous blood coagulum (ABC) in a surgically created wedge defect of the proximal tibia in patients undergoing high tibial osteotomy (HTO) for varus deformity and medial osteoarthritis of the knee. We enrolled 20 HTO patients in a randomized, placebo-controlled, double-blinded phase I/II clinical trial. RhBMP6/ABC (1.0 mg/10 mL ABC prepared from peripheral blood) or placebo (10 mL ABC containing excipients) was administered into the tibial wedge defects. Patients were followed for 0 to 24 months by clinical examination (safety) and computed tomography (CT) and serial radiographic analyses (efficacy). The results show that there were no detectable anti-rhBMP6 antibodies in the blood of any of the 20 patients at 14 weeks after implantation. During the 24 months of follow-up, there were no serious adverse reactions recorded. The CT scans from defects of patients treated with rhBMP6/ABC showed an accelerated bone healing compared with placebo at 9 weeks (47.8 ± 24.1 versus 22.2 ± 12.3 mg/cm 3 ; p = 0.008) and at 14 weeks (89.7 ± 29.1 versus 53.6 ± 21.9 mg/cm 3 ; p = 0.006) follow-up. Radiographic analyses at weeks 6 and 24 and months 12 and 24 suggested the advanced bone formation and remodeling in rhBMP6/ABC-treated patients. In conclusion, we show that rhBMP6/ABC at a dose of 100 μg/mL accelerated bone healing in patients undergoing HTO without serious adverse events and with a good tolerability compared with placebo alone. Overall, for the first time, a BMP-based osteogenic implant was examined against a placebo for bone healing efficacy in the trabecular bone surface, using an objective bone mineral density measurement system. © 2020 The Authors. Journal of Bone and Mineral Research published by American Society for Bone and Mineral Research.
(© 2020 The Authors. Journal of Bone and Mineral Research published by American Society for Bone and Mineral Research.)
Databáze: MEDLINE
Externí odkaz: