Evaluating a new treatment for chronic low back pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the effectiveness and safety of a combination treatment of rexlemestrocel-L and hyaluronic acid (HA) for individuals suffering from moderate to severe chronic low back pain due to degenerative disc disease. Participants will receive a single injection of the treatment into the affected lumbar intervertebral disc and will be monitored for pain reduction and safety over a 12-month period. The study compares the treatment group to a control group receiving saline to determine the efficacy of the new therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Axsendo Clinical Research/Summa Pain Care
  Phoenix, Arizona, United States Recruiting
• Pain Institute of Southern Arizona
  Tucson, Arizona, United States Recruiting
• TriWest Research Associates
  Chula Vista, California, United States Recruiting
• Boomerang Health Care
  Concord, California, United States Recruiting
• Memorial Orthopaedic Surgical Group
  Long Beach, California, United States Recruiting
• Newport Therapeutics
  Newport Beach, California, United States Recruiting

Study contacts

• Study coordinator: Roger D Brown
• Email: clinical@mesoblast.com
• Phone: 1 212 880 2060

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.