Mesoblast (NASDAQ:MESO) announced a significant clinical milestone on Wednesday, April 29, 2026, confirming that its pivotal Phase 3 trial (MSB-DR004) for rexlemestrocel-L has successfully met its patient recruitment target.
The study aims to address chronic low back pain (CLBP) associated with degenerative disc disease, a leading cause of global disability with limited treatment options.
The randomized, placebo-controlled trial has enrolled at least 300 patients across its study sites.
Participants are randomized to receive either a single intra-discal injection of rexlemestrocel-L or a sham control, with the primary efficacy endpoint being measured at a 12-month follow-up.
The trial is designed to confirm the durable pain reduction and functional improvements observed in previous clinical stages.
The completion of enrollment sets a definitive timeline for the company’s regulatory strategy.
Mesoblast expects to report top-line results from the study in mid-calendar year 2027.
Should the data prove positive, the company plans to submit a regulatory filing for marketing authorization in the third quarter of 2027.
Rexlemestrocel-L has already been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA), which provides intensive guidance on efficient drug development and potential priority review.
Chronic low back pain represents a substantial commercial opportunity for Mesoblast, as the therapy targets patients who have failed conservative care but are not yet candidates for invasive spinal surgery.
By utilizing an allogeneic (off-the-shelf) cell therapy approach, Mesoblast intends to offer a minimally invasive alternative that addresses the underlying inflammation and disc degeneration.