drugset / Trial / NCT06325566
Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2024-07-03
- Primary completion
- 2027-07
- Completion
- 2028-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rexlemestrocel-L | Cell therapy | 6e+06 cells | Other |
| Background | Hyaluronic Acid | Other / unclassified | 1 ml | Other |