Abstract

Clinical Application of Osteoblastic Cell-based Therapy in Spinal Fusion

Wendy Sonnet, Clinical Study Manager, Bone Therapeutics

Bone Therapeutics develops innovative osteoblastic cell therapy products for the treatment of orthopaedic and spinal conditions. The company is currently evaluating its human allogeneic osteoblastic cell therapy product, ALLOB®, in spinal fusion. Although spinal fusion is commonly performed, non-union and persisting pain are still frequent irrespective of the procedure and bone graft used. The local implantation of ALLOB® in combination with bioceramic granules is expected to provide the necessary osteogenic, osteoinductive and osteoconductive properties for the enhancement of bone formation and fusion. Preclinical studies with ALLOB® have shown excellent safety and efficacy results. Indeed, in a mouse model of osteotomy, combining ALLOB® with granules significantly increases bone formation and fusion rates as compared to granules alone. Bone Therapeutics initiated a pilot Phase IIA open-label study to assess the safety and efficacy of ALLOB® in patients requiring a spinal fusion. Sixteen patients with symptomatic lumbar disc disease will be treated with a single dose of ALLOB® combined with bioceramic granules to promote bone formation and fusion of the vertebral bodies. The ALLOB®-treated patients will be evaluated over a 12-month period using both clinical and radiological parameters. To date, the first patient cohort has been treated without any complications or safety issues.