Phase 3Completed
Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyaluronic Acid in Participants With Chronic Low Back Pain (MSB-DR003)
A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of a Single Injection of Rexlemestrocel-L Alone or Combined With Hyaluronic Acid (HA) in Subjects With Chronic Low Back Pain
- Sponsor
- Mesoblast, Ltd. (Industry)
- Enrolment
- 404 enrolled
- Conditions
- Degenerative Disc Disease
- Interventions
- Rexlemestrocel-L; Rexlemestrocel-L + HA Mixture; Placebo
- Ages
- adults, older adults
- Registry
- NCT02412735
From the registry
This is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the safety and efficacy of Mesoblast's rexlemestrocel-L alone or combined with hyaluronic acid (HA) in participants with chronic low back pain (\> 6 months) associated with moderate radiographic degenerative changes of a disc.
Primary outcomes
- Overall Treatment Success: Bayesian Estimated Response Rate