Mesoblast (ASX: MSB, USOTC: MBLTY) has proven that its NeoFuse stem cell product is as effective for interbody lumbar fusion as the gold standard, bone autograft, without the need for a second surgical procedure and its associated risks.
A phase two clinical trial of the NeoFuse product comprising allogeneic Mesenchymal Precursor Cells (MPCs) has successfully met its safety and efficacy endpoints.
Importantly, these results support the progression of clinical development of NeoFuse to a phase three trial in interbody lumbar fusion.
MPCs were well tolerated with no cell-related serious adverse events and no evidence of any ectopic bone formation.
At 12 months, fusion was achieved in 85.7% and 62.5% of patients in the low and high MPC treatment groups compared to 75% of patients who received bone autograft.
Significant improvements in low back pain scores and total disability index were seen in both MPC groups and were comparable to those receiving bone autograft.
Notably, those receiving MPCs had 30% to 43% less blood loss during the surgical procedure than those receiving bone autograft.
Significant market potential
For patients whose spinal discs have degenerated too extensively for repair, bone fusion of adjacent vertebra is the primary option to eliminate chronic and debilitating pain.
Other than autograft, there is no approved product for posterior spinal fusion, a surgical approach which accounts for 62% of all lumbar fusion procedures.
There is a critical unmet need for new technologies to achieve fusion that are safe, effective, and that eliminate the need for bone autograft.
According to Millennium Research Group, in the U.S. there were around 380,000 lumbar spinal fusion procedures performed in 2012.
They estimate the overall worldwide market for bone graft substitutes to be nearly $1.6 billion dollars in 2012 with the majority of bone graft revenues, about 70%, coming from spinal fusion procedures.
Mesoblast plans to initiate a phase three trial for interbody lumbar fusion later this year, with patients to be enrolled across multiple sites in the U.S., Europe and Australia.
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