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First Minimally Invasive Procedure Performed In Disc Repair Stem Cell Trial

Mon, 08/22/2011 - 6:08am

PRNewswire/ -- Mesoblast Limited has announced that the first minimally-invasive lumbar disc procedure has been successfully performed in the Phase 2 clinical trial of its proprietary adult Mesenchymal Precursor Cell (MPC) product for the treatment of low back pain and degenerative disc disease. The outpatient procedure lasted less than 20 minutes, with the patient fully awake and under light sedation. The patient was shortly discharged and there were no complications.

The procedure was undertaken by spine surgeon, Kenneth Pettine, M.D., at the Spine Institute and Loveland Surgery Center in Colorado. Dr Pettine is a founder of the Spine Institute, an international leader in non-fusion surgery of the spine, and the co-inventor of Medtronic's Maverick artificial lumbar disc device. Up to 15 percent of people in industrialized countries have chronic low back pain lasting more than six months. For those with progressive, severe and debilitating pain due to ongoing progression of disc degeneration, the only option is major back surgery involving artificial disc replacement or spinal fusion.  

Both types of surgery are associated with significant risks, and the avoidance of surgery is a major objective of new treatments for degenerative disease of the spine. In pre-clinical trials, a single minimally invasive injection of Mesoblast's allogeneic MPCs into severely damaged intervertebral discs resulted in significant reversal of the degenerative process, re-growth of disc cartilage, and sustained normalization of disc pathology, anatomy and function for at least six months.

Building on these results, Mesoblast aims to show that a single minimally-invasive injection of its allogeneic or off-the-shelf disc repair MPC product can regenerate damaged discs, thereby reducing pain, improving function and avoiding surgery. Mesoblast's Phase 2 trial, which was cleared by the United States Food and Drug Administration (FDA) last month, will enroll 100 patients with chronic low back pain due to lumbar disc degeneration in 15 centers across the United States and Australia, comparing outcomes at six months in 60 patients receiving MPC injections against 40 patients receiving control injections.

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