The Allob phase IIa spinal fusion trial has treated 12 patients without any safety concerns, according to a company release from Bone Therapeutics.
Bone Therapeutics is attempting to address the lack of fusion which can occur with the treatment of degenerative disc disease by spinal fusion with Allob, its allogeneic bone-forming cell product.
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 will be assessed over 12 months, using clinical and radiological evaluations. The trial is currently running in eight centres across Belgium. According to a company release the procedure has so far been performed in 12 patients without any complications or safety issues.
Enrico Bastianelli, chief executive officer of Bone Therapeutics, comments: “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.”