Spinal Surgery

January 21, 2013

Mesoblast released results from a phase II trial of NeoFuse, comprised of allogeneic Mesenchymal Precursor Cells (MPCs), for the treatment of lumbar spinal fusion. This randomized, multi-center study enrolled 24 patients. Subjects were divided into three arms and received bone autograft standard of care (control), or 25M MPCs or 75M MPCs. Patients underwent the surgical procedure, one or two level fusions using a posterior approach to the spine, and were evaluated for safety and efficacy. The median follow-up times for the three treatment groups were 23.9, 20.7 and 22.9 months, respectfully. Data demonstrated that at 12 months, fusion was achieved in 85.7% of patients in the 25M treatment group compared to 62.5% in the 75M and 75% in the control patient groups. Overall, patients from all three treatment groups had a clinically significant and comparable decrease in low back and leg pain, assessed on the Visual Analogue Scale, and functional improvement, assessed by the Oswestry Disability Index questionnaire. Notably, MPC treated groups had 30%-43% lower mean estimated blood loss during surgery compared to the autograft treatment group (p<0.05 for the 25M group). NeoFuse was well tolerated, with no cell-related serious adverse events and no ectopic bone formation at all. Based on these results, Mesoblast plans to initiate a phase III trial for interbody lumbar fusion in 2013, with patients to be enrolled across multiple sites in the U.S., Europe and Australia.