Laboratory for Mineralized Tissues, Center of Excellence for Regenerative Medicine, Center for Translational and Clinical Research, University of Zagreb School of Medicine, CROATIA
Thursday, 31 March 2022 | 12:00 noon – ICGEB Trieste, ITALY
Bone Morphogenetic Proteins: Growth and differentiation factors in regeneration of organs
Host: S. Zacchigna
It is widely known that secondary resistance inevitably leads to treatment failure through Darwinian
Bone morphogenetic proteins (BMPs) have critical roles in the regeneration of organs and systemic effects on insulin secretion, serotonin activity and iron regulation. They were discovered as bone inducing growth factors, and rhBMP2 (InFuse) and rhBMP7 (Ossigraft) have been approved for clinical use. We recently developed a novel autologous bone graft substitute (OSTEOGROW) implant composed of recombinant human BMP6 (rhBMP6) delivered in autologous blood coagulum (ABC). OSTEOGROW contains low doses of BMP6 and is free of animal sourced collagen, not causing inflammation and immune responses. Safety and efficacy preclinical studies using rabbit ulna segmental defect model and posterolateral lumbar spine fusion models in rabbits and sheep have been conducted. OSTEOGROW was examined alone and in combination with allograft or synthetic ceramics as compression resistant matrices (CRM) in spine fusion models. OSTEOGROW induced a robust bone formation resulting in restoration of segmental defects and complete ectopic bone fusion with adjacent transverse processes at bilateral lumbar spine sites.
The safety and efficacy of OSTEOGROW was tested in Phase I/II randomized, double blind, placebo controlled trials in patients with a distal radius fracture (DRF) and high tibial osteotomy (HTO). OSTEOGROW was formulated to render a flexible and injectable implant. In the DRF study, three groups of patients were enrolled: standard of care, ABC alone and OSTEOGROW (ABC+rhBMP6). The HTO trial was conducted in 20 patients treated with 10 ml ABC containing placebo or 1 mg rhBMP6. Evaluation of OSTEOGROW with allograft is in progress after finalized recruitment of 143 patients with degenerative disc disease to a randomized Phase II posterolateral lumbar interbody fusion (PLIF) study. Phase III trials will include patients with weight bearing long bone non-unions and transforaminal lumbar interbody fusion (TLIF) in patients with degenerative disc disease. This novel biological drug OSTEOGROW is safe, accelerates bone formation and will serve to improve quality of life in patients with debilitating chronic conditions, like long bone nonunions and lumbar back pain.
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