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Bone Abstracts (2016) 5 P66 | DOI: 10.1530/boneabs.5.P66

1Laboratory for Mineralized Tissues, School of Medicine, University of Zagreb, Zagreb, Croatia; 2Genera Research, Zagreb, Croatia.


High doses of BMPs are needed to achieve clinical success in bone fracture repair with currently available devices. BMP6 has a higher potency in stimulation of bone formation then its paralogue BMP7 due to less susceptibility to Noggin. The BMP6 carrier is a whole blood derived coagulum (WBCD) from the peripheral blood (OSTEOGROW). This WBCD, as an endogenous biocompatible material, significantly reduces the inflammatory response associated with current BMP-based treatments. More than 90% of BMP6 added to the full blood remains incorporated, bound mainly to its extracellular matrix components. Release of BMP6 from the coagulum in in vitro conditions showed slow discharge from the coagulum with a mean residence time of ~7 days. Proof of concept studies have been conducted in rabbit and rat models of bone defects. These showed that BMP6 accelerated and enhanced radiographic bone union across the defect. Pharmacokinetic studies, following intravenously (iv) dosing, have been conducted in a Bmp6 knock-out mice, rats and in rabbits. Presence of BMP6 in circulation is minimal after systemic application and BMP6 is not distributed into the deep tissue compartment. Implant studies conducted in the rat have shown negligible absolute bioavailability of paraosseally administered BMP6 in WBCD. A single dose GLP toxicology study conducted in rats showed absence of BMP6 related adverse effects when rhBMP6 was administered iv in doses up to 450 μg/kg, which is around 300-fold higher than the maximum anticipated human dose, assuming 5% bioavailability. The clinical grade of BMP6 is currently tested in two indications for regeneration of the metaphyseal bone, compartments where BMP2 and BMP7 have not been effective. Safe, affordable and non-toxic BMP6 based autologous carrier OSTEOGROW is expected to promote faster bone healing and reduce the need for secondary interventions.

Volume 5

43rd Annual European Calcified Tissue Society Congress

Rome, Italy
14 May 2016 - 17 May 2016

European Calcified Tissue Society 

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