NCT06325566

Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain

A Prospective, Multicenter, Randomized, Double-blind, Controlled Study to Evaluate the Efficacy and Safety of a Single Injection of Rexlemestrocel-L Combined With HA in Subjects With Moderate to Severe Chronic Low Back Pain

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Mesoblast, Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to evaluate the efficacy of rexlemestrocel-L+HA compared to control in reducing low back pain at 12 months post-treatment and safety of a single injection of rexlemestrocel-L+HA injected into a lumbar intervertebral disc compared to control through 12 months post-treatment.

Conditions

• Degenerative Disc Disease

Interventions

Type	Name	Description
DRUG	Rexlemestrocel-L + HA mixture	Rexlemestrocel-L will be combined in 1:1 by-volume ratio with HA solution and the resulting mixture will be administered as intradiscal injection.
DRUG	Saline	Saline solution injection adjacent to the index disc.

Timeline

• Start date: 2024-07-03
• Primary completion: 2026-10-01
• Completion: 2027-10-01
• First posted: 2024-03-22
• Last updated: 2026-01-27

Locations

39 sites across 1 country: United States

Regulatory

• FDA-regulated drug study