Mesoblast’s Neofuse stem cell product shows positive results in Phase 2 lumbar fusion trial

Results support progression of clinical development to Phase 3

16-Jan-2013 - Australia

Mesoblast Limited announced that its Phase 2 clinical trial for lumbar spinal fusion had met its safety and efficacy endpoints.

The results suggest that Mesoblast’s NeoFuse product comprising allogeneic Mesenchymal Precursor Cells (MPCs) is as effective for interbody lumbar fusion as the gold standard, bone autograft, without the need for a second surgical procedure and its attendant morbidity risks.  These results support the progression of clinical development of NeoFuse to a Phase 3 trial in interbody lumbar fusion.

24 patients were enrolled and randomized over 5 sites in the United States with 8 patients in each treatment arm – bone autograft standard of care (control), 25 million MPCs (25M), and 75 million MPCs(75M).  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 for the bone autograft, 25M, and 75M groups, respectively.

MPCs were well tolerated with no cell-related serious adverse events and no ectopic bone formation at all.  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). 

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.

Mesoblast plans to initiate a Phase 3 trial for interbody lumbar fusion later this year, with patients to be enrolled across multiple sites in the United States, Europe and Australia.

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