Trials Test ALLOB for Spine Repair

Bone Therapeutics SA’s ALLOB is a bone-forming cell therapy product used for the treatment of orthopedic conditions and bone diseases. It is being evaluated in three Phase I and II clinical trials for delayed-union fractures, spinal fusion and the revision of failed spinal fusions.

ALLOB has received orphan drug designation from the European Medicines Agency (EMA) in Europe and the FDA in the U.S. for two indications: osteonecrosis and osteogenesis imperfecta. ALLOB, Bone Therapeutics’ “off-the-shelf” bone cell product is created by harvesting of cells from a healthy donor, rather than from the treated patient.

Bone Therapeutics officials note that spinal fusion is considered the gold standard surgery for treating degenerative spine disorders. The process consists of bridging two or more vertebrae with the use of a cage and graft material. The intent is to fuse an unstable portion of the spine or immobilize a painful vertebral motion segment.

Despite the fact that spinal fusion surgery is routine, company officials claim that non-union and failure to relieve lower back pain remain the result of treatment in up to 30% of spinal fusion patients. Bone Therapeutics’ products, they say, are intended to improve the success rates of spinal fusion surgeries.

Founded in 2006, Bone Therapeutics is headquartered in Gosselies, (South of Brussels), Belgium. The company is developing a range of regenerative products containing osteoblastic bone-forming cells which may be administered via a minimally invasive percutaneous technique.