Key points: MELBOURNE, Australia, Jan. 11, 2013 (GLOBE NEWSWIRE) -- Regenerative medicine company Mesoblast Limited (ASX:MSB) (MBLTY) today announced that its Phase 2 clinical trial for lumbar spinal fusion had successfully 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. The results were highlighted during a presentation to the 31 st annual JP Morgan Healthcare Conference in San Francisco by Mesoblast Chief Executive Professor Silviu Itescu. Twenty four (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 … Continue reading →

AN Australian-invented stem cell treatment for spinal surgery has been successfully used for the first time in the United States. The patented stem cells product created by Melbourne-based company Mesoblast was trialled in a small group of patients with spinal discs that had degenerated beyond repair. The bone marrow-derived stem cells - called mesenchymal precursor cells (MPCs) - were used to promote bone growth to fuse together spinal vertebrae, to eliminate debilitating leg and back pain. If the procedure ultimately passes the final stage of clinical trials and is approved by America's drug regulator, it would potentially provide patients worldwide with a quicker and less invasive procedure. The Food and Drug Administration (FDA)-approved trial compared the use of stem cells to fuse vertebrae with bone harvested from the patient's own hip, the current gold standard for this common operation. The stem cells were used in conjunction with two chemicals to encourage bone growth, said Texas surgeon Dr Randall Dryer, who performed a number of surgical procedures in the trial. The chemicals, hydroxyapatite and tricalcium phosphate, are non-cellular components of bone that tell the stem cells to turn into bone-forming cells, rather than other tissues, Dr Dryer said. "If you put … Continue reading →