Scimitar Equity Blog

P2 Stem Cell Trial for Lumbar Disc Repair

ASX: MSB’S minimally-invasive lumbar disc procedure had been successfully performed in the P2 clinical trial of its 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;
• In preclinical trials, a single minimally invasive injection of MSB’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 6 months;
• Building on these results, MSB 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.  MSB’s P2 trial, which was cleared by the FDA last month, will enroll 100 patients with chronic low back pain due to lumbar disc degeneration in 15 centers across the US and Australia, comparing outcomes at 6 months in 60 patients receiving MPC injections against 40 patients receiving control injections.

The Bottom Line: There is a significant need for a minimally invasive biological solution to repair the degenerating disc, reduce back pain, improve function, and eliminate the need for surgery. MSB’s adult stem cell product could find broad use in the treatment of both early and late degenerative disc disease, and could additionally reduce spine surgery for this condition by as much as 80%. Up to 15% of people in industrialized countries have chronic low back pain lasting more than 6 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.