drugset / Trial / NCT02412735
Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyaluronic Acid in Participants With Chronic Low Back Pain
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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.
Timeline
- Start
- 2015-03-06
- Primary completion
- 2020-05-15
- Completion
- 2021-06-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hyaluronic Acid | Other / unclassified | — | — |
| Subject | Rexlemestrocel-L | Cell therapy | 2 ml | — |
| Subject | Rexlemestrocel-L | Cell therapy | 6 cells | — |