Date: 2015-09-28
Type of information: Treatment of the first patient
phase: 2a
Announcement: treatment of the first patient
Company: Bone Therapeutics (Belgium)
Product: ALLOB®
Action
mechanism: cell therapy. ALLOB® is an allogeneic, differentiated osteoblastic cell therapy product developed for the treatment of orthopaedic conditions. Allogeneic cell therapy involves the harvesting of cells from a healthy, universal donor, rather than from the patient being treated. ALLOB® has shown safety and efficacy in preclinical studies and does not require any immunosuppressive side therapy.
Disease: failed spinal fusion
Therapeutic area: Bone diseases - Regenerative medicine
Country:
Trial details:
Latest
news: * On September 28, 2015, Bone Therapeutics announced that it has treated the first patients suffering from a failed spinal fusion with its unique allogeneic bone cell therapy product ALLOB®. This is the first trial involving the administration of a bone cell therapy product percutaneously directly into the failed fusion area without an open procedure. The implantation of bone cells is intended to promote the fusion process through stimulation of bone formation. This study complements the key Phase IIA ALLOB® spinal fusion trial that was initiated last year. The study is a pilot, open, proof-of-concept Phase IIA trial to evaluate the safety and the efficacy of ALLOB® implantation in rescue spinal fusion over 12 months. Sixteen patients diagnosed with a failed lumbar spinal fusion at 15 months or more following the initial surgery, and requiring a rescue surgery, will be treated with a single percutaneous implantation of ALLOB® cells into the failed fusion area. The process is monitored by fluoroscopy to visualize and optimize the exact location of administration. The efficacy of the treatment will be evaluated clinically and radiologically by CT-scan. ESpinal fusion surgery is routine, with around one million procedures performed each year in Europe and the US. For the lumbar spine, which accounts for half a million fusion procedures each year, non-union and failure to relieve lower back pain are still frequent outcomes. It is estimated that up to one quarter of spinal fusion procedures are unsuccessful. Standard of care revision procedures require open surgery and are associated with several factors that present more difficulties than the initial surgery, consequently increasing the risk of complications. For example, fibrosis and scarring make revision surgery significantly more difficult and vascular supply may be compromised. Bone Therapeutics’ rescue procedure is designed to be safer and easier compared to the existing procedures.
