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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\u2009mg\/10\u2009mL ABC prepared from peripheral blood) or placebo (10\u2009mL ABC containing excipients) was administered into the tibial wedge defects. Patients were followed for 0 to 24\u2009months 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\u2009weeks after implantation. During the 24\u2009months 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\u2009weeks (47.8\u2009\u00b1\u200924.1 versus 22.2\u2009\u00b1\u200912.3\u2009mg\/cm3; p = 0.008) and at 14\u2009weeks (89.7\u2009\u00b1\u200929.1 versus 53.6\u2009\u00b1\u200921.9\u2009mg\/cm3; 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\u2009\u03bcg\/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. \u00a9 2020 The Authors. Journal of Bone and Mineral Research published by American Society for Bone and Mineral Research.<\/jats:p>","DOI":"10.1002\/jbmr.4107","type":"journal-article","created":{"date-parts":[[2020,6,16]],"date-time":"2020-06-16T08:53:05Z","timestamp":1592297585000},"page":"1893-1903","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":39,"title":["Recombinant Human BMP6 Applied Within Autologous Blood Coagulum Accelerates Bone Healing: Randomized Controlled Trial in High Tibial Osteotomy Patients"],"prefix":"10.1093","volume":"35","author":[{"given":"Catharina","family":"Chiari","sequence":"first","affiliation":[{"name":"Department of Orthopedics and Trauma Surgery Medical University of Vienna Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lovorka","family":"Grgurevic","sequence":"additional","affiliation":[{"name":"Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research University of Zagreb School of Medicine Zagreb Croatia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tatjana","family":"Bordukalo-Niksic","sequence":"additional","affiliation":[{"name":"Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research University of Zagreb School of Medicine Zagreb Croatia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hermann","family":"Oppermann","sequence":"additional","affiliation":[{"name":"Genera Research Rakov Potok Croatia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"Valentinitsch","sequence":"additional","affiliation":[{"name":"Department of Orthopedics and Trauma Surgery Medical University of Vienna Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"Nemecek","sequence":"additional","affiliation":[{"name":"Department of Orthopedics and Trauma Surgery Medical University of Vienna Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin","family":"Staats","sequence":"additional","affiliation":[{"name":"Department of Orthopedics and Trauma Surgery Medical University of Vienna Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Markus","family":"Schreiner","sequence":"additional","affiliation":[{"name":"Department of Orthopedics and Trauma Surgery Medical University of Vienna Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carmen","family":"Trost","sequence":"additional","affiliation":[{"name":"Department of Orthopedics and Trauma Surgery Medical University of Vienna Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"Kolb","sequence":"additional","affiliation":[{"name":"Department of Orthopedics and Trauma Surgery Medical University of Vienna Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Franz","family":"Kainberger","sequence":"additional","affiliation":[{"name":"Department of Orthopedics and Trauma Surgery Medical University of Vienna Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sanja","family":"Pehar","sequence":"additional","affiliation":[{"name":"Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research University of Zagreb School of Medicine Zagreb Croatia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Milan","family":"Milosevic","sequence":"additional","affiliation":[{"name":"Department of Environmental and Occupational Health and Sports, School of Public Health, \u201cAndrija Stampar,\u201d University of Zagreb School of Medicine Zagreb Croatia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Snjezana","family":"Martinovic","sequence":"additional","affiliation":[{"name":"SmartMedico Zagreb Croatia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mihaela","family":"Peric","sequence":"additional","affiliation":[{"name":"Department for Intracellular Communication, Centre for Translational and Clinical Research University of Zagreb School of Medicine Zagreb Croatia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T Kuber","family":"Sampath","sequence":"additional","affiliation":[{"name":"perForm Biologics Inc. 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