Bone Therapeutics treats first patients in ALLOB® phase IIA spinal fusion trial
Bone Therapeutics announced that the first four patients in the phase IIA proof-of-concept study for spinal fusion procedures have been treated with Bone Therapeutics’ allogeneic osteoblastic (bone-forming) cell therapy product, ALLOB®.
This pilot Phase IIA study will enrol 16 patients with symptomatic degenerative lumbar disc disease who require interbody fusion surgery[1]. Patients will be treated with a single dose of ALLOB® combined with bioceramic granules to achieve bone formation and fusion of the vertebral bodies. Safety and efficacy of this treatment will be assessed over 12 months, using clinical and radiological evaluation. Spinal fusion is a procedure that eliminates pain and restores the normal life of a patient but, despite being a fairly routine surgery, is often associated with high failure rates. Bone Therapeutics’ cell therapy product has been designed to accelerate the fusion process and reduce the failure rate of current surgeries.
Today, the procedure has been performed in four patients without any complications or safety issues. The trial is currently running in four centres across Belgium: the Erasmus Hospital in Brussels, the University Hospital of Charleroi, Brugmann University Hospital in Brussels and the Hospital Oost-Limburg in Genk.
ALLOB® is also currently being studied in a Phase I/IIA trial for the treatment of delayed-union fractures and recently reported excellent safety and efficacy from the treatment of the initial four patients.
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