Mesoblast to begin US spine surgery trial
This article was originally published in Clinica
Executive Summary
Mesoblast is to initiate a US phase II trial of its allogeneic adult stem cells in minimally-invasive lumbar spinal fusion surgery. The 24-patient trial will compare two low doses of Mesoblast's product, NeoFuse, with autografting of patients' own hip bones – the gold-standard treatment for this disorder. Previous trials assessing NeoFuse's use in spinal fusion performed via more invasive surgery showed that the therapy can generate safe and robust fusion over a 12-month period, Melbourne, Australia-based Mesoblast said. The firm will follow this trial, if it is successful, with a phase III study to enable US approval of NeoFuse.