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

• DOI: 10.1002/jbmr.4107
• Publication Date: 2020-06-16T12:53:05Z
• Authors: Catharina Chiari; Lovorka Grgurevic; Tatjana Bordukalo...; Hermann Oppermann; Alexander Valenti...; Elena Nemecek; Kevin Staats; Markus Schreiner; Carmen Trost; Alexander Kolb; Franz Kainberger; Sanja Pehar; Milan Milosevic; Snjezana Martinovic; Mihaela Peric; T Kuber Sampath; Slobodan Vukicevic; Reinhard Windhager
• Keywords: High tibial osteotomy

ABSTRACT Bone morphogenetic proteins (BMPs) are potent osteogenic that induce new bone formation in vivo. However, their effect on healing the trabecular surfaces remains challenging. We evaluated safety and efficacy of recombinant human BMP6 (rhBMP6) applied within an autologous blood coagulum (ABC) a surgically created wedge defect proximal tibia patients undergoing high tibial osteotomy (HTO) for varus deformity medial osteoarthritis knee. enrolled 20 HTO 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 containing excipients) was administered into defects. Patients were followed 0 to 24 months by examination (safety) computed tomography (CT) serial radiographic analyses (efficacy). The results show there no detectable anti-rhBMP6 antibodies any at 14 weeks after implantation. During follow-up, serious adverse reactions recorded. CT scans defects treated with rhBMP6/ABC showed accelerated compared 9 (47.8 ± 24.1 versus 22.2 12.3 mg/cm3; p = 0.008) (89.7 29.1 53.6 21.9 0.006) follow-up. Radiographic 6 12 suggested advanced remodeling rhBMP6/ABC-treated patients. In conclusion, we dose 100 μg/mL without events good tolerability alone. Overall, first time, BMP-based implant examined against surface, using objective mineral density measurement system. © 2020 Authors. Journal Mineral Research published American Society Research.