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
Mesoblast, Ltd.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants with moderate to severe low back pain for a duration of at least six months who have failed at least 3 months of conservative care. * Participants who have moderate radiographic degeneration of an intervertebral disc from L1 to S1, with a single disc suspected of causing chronic lower back pain (CLBP). Exclusion Criteria: * Participants who have been a recipient of prior allogeneic stem cell/progenitor cell therapy for any indication or autologous stem cell/progenitor cell therapy or other biological intervention to repair the index intervertebral disc. *…
Interventions
- DrugRexlemestrocel-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.
- DrugSaline
Saline solution injection adjacent to the index disc.
Locations (39)
- Axsendo Clinical Research/Summa Pain CarePhoenix, Arizona
- Pain Institute of Southern ArizonaTucson, Arizona
- TriWest Research AssociatesChula Vista, California
- Boomerang Health CareConcord, California
- Memorial Orthopaedic Surgical GroupLong Beach, California
- Newport TherapeuticsNewport Beach, California