Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain

Inclusion Criteria:

• Participants with moderate to severe low back pain for a duration of at least sixmonths who have failed at least 3 months of conservative care.

• Participants who have moderate radiographic degeneration of an intervertebral discfrom 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 celltherapy for any indication or autologous stem cell/progenitor cell therapy or otherbiological intervention to repair the index intervertebral disc.

• Participants with low back pain duration of less than 6 months or greater than 60months.

• Participants who have not received at least 3 months of conservative treatment forback pain without adequate pain relief.

• Participants taking systemic immunosuppressants.

• Participants with osteoporosis.

• Participants with alcohol or substance abuse problems.

• Participants with severe depression or anxiety.

• Participants with cauda equina syndrome; fibromyalgia, symptomatic central vertebralcanal stenosis, lumbar spondylitis or other undifferentiated spondyloarthropathyaffecting the index disc.

• Participants having undergone a surgical procedure affecting thestructure/biomechanics of the disc (e.g., discectomy, intradiscal electrothermaltherapy, intradiscal radiofrequency, artificial disc replacement, interbody fusion,laminectomy, etc.) at the index or adjacent levels.

• Participants who have received any lumbar intradiscal injection into the index discor adjacent discs within three months prior to the start of screening, other thaninjection of contrast medium for discography.

• Participants who received an epidural steroid injection within 6 weeks prior toinformed consent.

• Participants with evidence of neurologic deficit on any component of the lumbarneurological exam at baseline.

• Participants with sacroiliac (SI) joint pain, as determined by a targeted physicalexam, or SI joint injection.

• Participants with facet joint pain, as determined by a medial branch block.

• Participants with more than a single painful level.

• Participants with a full thickness annular tear observed on magnetic resonanceimaging (MRI) or discography.

• Participants with low back pain that is less than moderate in severity.

• Participants with extreme low back pain.

• Participants who lack moderate to extreme functional limitations/disability.

Note: Other exclusion criteria may apply.