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Mesoblast Completes Enrollment of 300 Patients in Rexlemestrocel-L Back Pain Trial
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.
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The Wire takeaway
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.
Read the full story at clinicaltrialvanguard.com →
Topics: Digital Health · cell-therapy · clinical-trials · regenerative-medicine · pain-management · regulatory-pathway · opioid-replacement