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

Launched by MESOBLAST, LTD. · Mar 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a treatment called rexlemestrocel-L combined with hyaluronic acid (HA) for people suffering from moderate to severe chronic low back pain caused by degenerative disc disease. The goal is to see if this treatment can help reduce pain after 12 months compared to a control group that does not receive the treatment. Participants will receive a single injection of the treatment directly into their lower back, specifically targeting the affected disc.

To be eligible for this study, participants should be between 65 and 74 years old and have had moderate to severe low back pain for at least six months, despite trying other treatments for at least three months. Certain health conditions may disqualify individuals from participating, such as previous stem cell treatments for back pain, specific medical conditions like osteoporosis, or recent back surgeries. Participants can expect to closely monitor their pain levels and overall health throughout the year following the treatment, and they will be part of a study designed to help improve options for managing chronic low back pain in the future.

Gender

ALL

Eligibility criteria

• 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.
• • Participants with low back pain duration of less than 6 months or greater than 60 months.
• • Participants who have not received at least 3 months of conservative treatment for back 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 vertebral canal stenosis, lumbar spondylitis or other undifferentiated spondyloarthropathy affecting the index disc.
• • Participants having undergone a surgical procedure affecting the structure/biomechanics of the disc (e.g., discectomy, intradiscal electrothermal therapy, 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 disc or adjacent discs within three months prior to the start of screening, other than injection of contrast medium for discography.
• • Participants who received an epidural steroid injection within 6 weeks prior to informed consent.
• • Participants with evidence of neurologic deficit on any component of the lumbar neurological exam at baseline.
• • Participants with sacroiliac (SI) joint pain, as determined by a targeted physical exam, 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 resonance imaging (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.