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Despite the natural regenerative capacity of bone, there are instances where healing is impaired and clinical intervention necessary. Examples include when the quantity of bone required is simply beyond the body’s natural regenerative capacity, such as in the skeletal reconstruction of large defects resulting from trauma or invasive surgeries (e.g. osteosarcoma excision), delayed or non-unions, or when the natural regenerative capacity is impaired due to osteoporosis or avascular necrosis.
Current clinical approaches used to simulate or augment bone regeneration when the quantity of bone required is simply beyond the body’s natural regenerative capacity, include distraction osteogenesis and bone transport, autologous or allogeneic bone grafts, or the application of bone graft substitutes containing hyper-concentrated growth factors such as bone morphogenetic proteins, but none of these clinical interventions can be considered optimal and have significant limitations: autologous grafts cannot meet demand and cause patient morbidity, allogeneic bone lacks bioactive factors, and growth factor-based approaches (e.g. BMP-2) may have serious side- effects and high costs. Consequently, there is a considerable need to devise new methods for the generation of large volumes of bone without associated patient morbidity.
Academics at the University of Birmingham have developed a novel solution to promote bone formation/regeneration, where osteoblast cells are stimulated to produce osteogenesis-enhancing extracellular vesicles in the presence of an osteoconductive donor substrate and bone marrow-derived stem cells (MSCs), which are then therapeutically delivered to the site of need to facilitate hard tissues regeneration.
The team have shown in vitro that if extracellular vesicles are applied in combination with a simple phosphate the therapy outperforms the current gold standard, BMP-2. The newly formed bone has improved bone quality, quantity and density versus current gold standard of care with BMP-2.
The method and composition of the invention may be also used to promote fusion of two bones or bone fragments; to promote spinal fusion, for example to treat lumbar degenerative disc disease. The composition may be administered via a spinal cage which may be used to provide load bearing support to the vertebrae.