Biotechnology firm Mesoblast has received approval at Melbourne’s Epworth hospital to commence a Phase 2 trial of its allogeneic, or “off-the-shelf”, cell therapy product for fusion of the cervical spine.
Australian regenerative medicine company, Mesoblast Limited develops treatments for orthopaedic conditions, including an adult stem-cell technology aimed at the regeneration and repair of bone and cartilage.
In phase I trials which was recently completed at Australia’s Monash University, Mesoblast’s allogeneic cells resulted in earlier and more robust fusion of the cervical spine than autograft, without any adverse events.
In phase II a 24-patient randomised, controlled trial will compare the safety and effectiveness of Mesoblast’s product NeoFuse(TM) against a procedure using a patient’s own hipbone (autograft).
The trial will compare the safety and effectiveness of Mesoblast’s product, NeoFuse, against a fusion procedure using a patient’s own hipbone.
Presently Mesoblast is looking forward to progress through necessary clinical trials and international regulatory processes to commercialise the technology in as early as possible. cervical fusion represented a major, new market opportunity for the treatment of spinal diseases, which include spinal fusion of the lumbar (the lower back) and cervical (neck) vertebrae for end-stage degenerative intervertebral disc disease, and repair/regeneration of the discs for patients with earlier stage disease.