Phase 3Active, not recruiting
Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain (HyaluronicAcid)
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
- Sponsor
- Mesoblast, Ltd. (Industry)
- Enrolment
- 300 planned
- Conditions
- Degenerative Disc Disease
- Interventions
- Rexlemestrocel-L + HA mixture; Saline
- Ages
- adults, older adults
- Registry
- NCT06325566
From the registry
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.
Primary outcomes
- Mean Change From Baseline in Daily Average Low Back Pain at 12 Months Post-treatment Based on Visual Analog Scale (VAS) Score
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)