Mesoblast Completes Enrollment of 300 Patients in Rexlemestrocel-L Ba…

Mesoblast has completed enrolment of 300 patients in its pivotal MSB-DR004 trial of rexlemestrocel-L, an allogeneic stromal cell therapy for chronic low back pain, with a mid-2027 data readout locked in by the 12-month primary endpoint. The product holds RMAT designation enabling Priority Review at the BLA stage, and the company is running commercial manufacturing in parallel, signalling confidence ahead of filing. If rexlemestrocel-L's efficacy signal holds through month 12, a single lumbar injection that cuts opioid use becomes a commercial pharmacoeconomic argument, not just a pain claim—opening the door to payer adoption and triggering demand for manufacturing scale-up partners in cell processing and cold-chain logistics. Watch the dropout rate between now and mid-2026: patient retention through a year-long follow-up for a one-shot therapy will determine whether the trial's statistical power survives to BLA filing.