Bone Therapeutics treats 12 patients without safety concerns in ALLOB phase IIA spinal fusion trial

The trial is progressing quickly with only one more patient cohort of four patients to treat.

Spinal fusion is the current standard of care for degenerative disc disease to relieve pain and improve function. However, this surgery often results in lack of fusion and continuing pain, leaving 25% to 30% of patients unsatisfied with their surgery.

Bone Therapeutics is seeking to address this through the inclusion of its allogeneic bone forming cell product ALLOB in the procedure.

The pilot Phase IIA study with ALLOB will enrol a total of 16 patients with symptomatic degenerative lumbar disc disease who require interbody fusion surgery. An interbody cage is implanted according to the standard-of-care surgical approach, supplemented with ALLOB in combination with bioceramic granules.

Safety and efficacy of this treatment is assessed over 12 months, using clinical and radiological evaluations. The trial is currently running in eight centres across Belgium. Today, the procedure has been performed in 12 patients without any complications or safety issues.

On February 24, the Company will present efficacy data on the first patient treated in the trial at the ‘Clinical Applications of Stem Cells’ Conference in Singapore. The presentation is entitled Clinical Application of Osteoblastic Cell-based Therapy in Spinal Fusion and will be presented by Wendy Sonnet, PhD, clinical project manager at Bone Therapeutics.

Bone Therapeutics CEO Enrico Bastianelli said: "We are pleased to see consistent safety being reported with our allogeneic bone cell therapy product. Recruitment for the spinal fusion trial is progressing quickly and is now 75% complete. We look forward to updating the market on the first efficacy results."