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Rexlemestrocel-L + HA for Chronic Low Back Pain

This study is testing a new treatment called Rexlemestrocel-L combined with hyaluronic acid (HA) for people with moderate to severe chronic low back pain caused by degenerative disc disease. Researchers want to see if this combination, given as an injection into the disc, can reduce your pain more effectively than a saline injection. They will measure your pain levels after 12 months and also track any side effects for up to 24 months. You might be able to join if you're an adult (18 or older) who has had low back pain for at least six months, and other treatments haven't worked for you. You also need to have moderate degeneration in a single disc in your lower back that is believed to be causing your pain. The current recruitment status is unclear.

Study design
This study plans to enroll 300 participants. It compares the Rexlemestrocel-L + HA mixture to a saline injection.
What's involved
Participants will receive an intradiscal injection of either the study drug or saline. Pain levels will be measured at the start and at 12 months after treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for pain levels at 12 months post-treatment and for safety events for up to 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06325566

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

Active, Not Recruiting
PHASE3Ages 18+InterventionalTreatment
Mesoblast, Ltd.
~300 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:Rexlemestrocel-L + HA mixtureSaline

At a glance

Recruiting sites
0 of 40 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean Change From Baseline in Daily Average Low Back Pain at 12 Months Post-treatment Based on Visual Analog Scale (VAS) Score
Measured over Baseline and Month 12
+1 more outcome measured

Conditions

Degenerative Disc Disease

Explore related trials

Intervertebral Disc Degenerative Disorder

NCT06325566

Where you'd take part

This study runs at 40 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • AdventHealth Hendersonville

    Hendersonville, North Carolinano site contact published

  • Apex Research Group

    Fair Oaks, Californiano site contact published

  • Axsendo Clinical Research/Summa Pain Care

    Phoenix, Arizonano site contact published

  • Axsendo Clinical Research/Texas Institute of Pain and Spine

    Pearland, Texasno site contact published

  • Bold City Clinical Research

    Jacksonville, Floridano site contact published

  • Boomerang Health Care

    Concord, Californiano site contact published

  • Cantor Spine Center at the Paley Orthopedic & Spine Institute

    Fort Lauderdale, Floridano site contact published

  • Clinical Investigations, LLC

    Edmond, Oklahomano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Roger D Brown · STUDY_DIRECTOR · Mesoblast, Ltd.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Mean Change From Baseline in Daily Average Low Back Pain at 12 Months Post-treatment Based on Visual Analog Scale (VAS) ScoreBaseline and Month 12

    Low back pain intensity will be measured using a VAS ranging from 0-100 millimeter (mm). A score of 0 represents no pain and 100 represents worst possible pain.

  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)Up to Month 24