OSTEOGROW – novel bone device for bone regeneration

Sa？etak Molecular processes required for bone repair are a prerequisite for the development of new biological procedures for stimulation of bone healing. Currently, there is no adequate therapy available that can accelerate long bone fractures healing. Specifically there is a need for the development of a new osteogenic device that will offer safe healing in particular of the trabecular bone. The Osteogrow project has developed a new therapy that promises to be safe and cost-effective and might decrease the need for secondary interventions. The Osteogrow device contains an autologous blood coagulum (ABC) made from the peripheral blood and recombinant bone morphogenetic protein 6 (BMP6). BMP6 has been selected as compared to BMP2 or BMP7/OP1 as it does not bind avidly to the BMP antagonist Noggin. ABC was chosen as a substrate for the delivery since BMP6 binds tightly to the number of plasma proteins resulting in the sustained and linear release over seven to ten days without provoking inflammation and immune responses. With support of the EU FP7 grant we have completed the preclinical development of Osteogrow and started Osteogrow first in humans (FIH) clinical studies. Osteogrow is tested clinically in two indications: the distal radial fracture and high tibial osteotomy to establish the safety and potential efficacy for Osteogrow for regeneration of the metaphyseal bone. Beyond currently tested clinical indications, this therapy would also be employed for posterolateral spinal fusion to treat degenerative spine disorders