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Evaluating a new treatment for chronic low back pain

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

Phase 3 Interventional Mesoblast, Ltd. · NCT06325566

This study is testing a new injection treatment for people with chronic low back pain from degenerative disc disease to see if it can reduce their pain better than a saline solution.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment300 (estimated)
Ages18 Years and up
SexAll
SponsorMesoblast, Ltd. Industry-sponsored
Locations39 sites (Phoenix, Arizona and 38 other locations)
Trial IDNCT06325566 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals with moderate to severe low back pain lasting at least six months who have not found relief from conservative treatments.

Not a fit: Patients who have received prior stem cell therapies or have certain medical conditions such as osteoporosis or severe depression may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce chronic low back pain and improve quality of life for patients suffering from degenerative disc disease.

How similar studies have performed: While similar approaches have been explored, this specific combination treatment is novel and has not been widely tested in prior studies.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Phoenix, Arizona and 38 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Degenerative Disc Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.