Phase 3 trial for single-dose back pain treatment nears completion

Mesolab’s Phase 3 trial for rexlemestrocel-L, a single-dose injection targeting degenerated spinal discs, is finalizing results for chronic low back pain treatment.

Mesolab completed a Phase 3 clinical trial for rexlemestrocel-L, a drug derived from human bone marrow designed to treat chronic low back pain (CLBP) caused by degenerative disc disease. The trial enrolled 350 participants (expanded from an initial target of 300) who received either a single intra-discal injection of rexlemestrocel-L or a sham injection. Primary evaluation focused on pain relief at 12 months post-treatment, with secondary assessments of physical function and medication discontinuation. The drug holds U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) designation for CLBP, prioritizing review if Phase 3 goals are met. Expected results will be available by mid-2027.

If successful, rexlemestrocel-L could potentially address chronic low back pain treatment costs for an estimated 430 million people with a single-dose regimen—though this figure represents projected market impact, not confirmed clinical efficacy. The drug targets individuals with disease duration under five years, limiting its scope to a subset of CLBP cases.

This development moves abundance toward reducing long-term treatment burdens for a large population. If the primary endpoint of sustained pain relief is achieved, it could lower costs for millions currently relying on ongoing therapies. However, the 430 million figure is a market projection, not verified efficacy. The trial’s outcome—whether it meets the 12-month pain relief benchmark—will determine whether this approach becomes a scalable solution for back pain management. The next critical step is the mid-2027 results, which will clarify whether the drug delivers on its potential to reduce treatment dependency for a significant group.

Source: New Atlas