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One-Shot stem cell treatment aims to quiet aching backs

NCT ID NCT06325566

Symptom relief Sponsor: Mesoblast, Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a single injection of rexlemestrocel-L (a type of stem cell) combined with hyaluronic acid can reduce chronic low back pain for at least 12 months. It involves 300 adults with moderate to severe pain from a worn spinal disc who haven't improved with standard care. The main goal is to measure pain relief and safety compared to a control injection.

Why investors are watching

Mesoblast is running a Phase 3 trial of its cell therapy, rexlemestrocel-L, as a single injection for chronic low back pain. The trial tests whether the treatment reduces pain at 12 months compared to a control, and a clear result matters because this small company's value rests heavily on this product's success.

If it works: A positive result could support a regulatory submission and bring Mesoblast closer to its first commercial product in a large patient population. That would give the company a concrete path to revenue.

If it fails: A failed or delayed trial could set the program back years and put the company under financial strain. Late-stage trials often fail, so investors should treat the outcome as uncertain.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

intervertebral disk degenerative disorder lumbar disk degenerative disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Degenerative disc disease

Contacts and locations

Locations

  • AdventHealth Hendersonville

    Hendersonville, North Carolina, 28792, United States

  • Apex Research Group

    Fair Oaks, California, 95628, United States

  • Axsendo Clinical Research/Summa Pain Care

    Phoenix, Arizona, 85085, United States

  • Axsendo Clinical Research/Texas Institute of Pain and Spine

    Pearland, Texas, 77584, United States

  • Bold City Clinical Research

    Jacksonville, Florida, 32224, United States

  • Boomerang Health Care

    Concord, California, 94520, United States

  • Cantor Spine Center at the Paley Orthopedic & Spine Institute

    Fort Lauderdale, Florida, 33306, United States

  • Clinical Investigations, LLC

    Edmond, Oklahoma, 73034, United States

  • Clinical Trials of South Carolina

    Charleston, South Carolina, 29406, United States

  • Colorado Spine Partners/The Denver Spine and Pain Institute

    Greenwood, Colorado, 80111, United States

  • Conquest Research LLC

    Winter Park, Florida, 32789, United States

  • Elevate Clinical Research

    Rockville, Maryland, 20852, United States

  • Emory Healthcare

    Dunwoody, Georgia, 30338, United States

  • Eximia EquiHealth Research LLC/Emerge Ortho

    Durham, North Carolina, 27704, United States

  • Hawaii Pain & Spine

    Kailua, Hawaii, 96734, United States

  • Innovative Pain Treatment Solutions

    San Diego, California, 92111, United States

  • Institute of Precision Pain Medicine

    Corpus Christi, Texas, 78414, United States

  • Interventional Pain Institute

    The Villages, Florida, 32162, United States

  • Iqra Research

    Edgewood, Kentucky, 41017, United States

  • Memorial Orthopaedic Surgical Group

    Long Beach, California, 90806, United States

  • Meta Medical Research Institute, LLC

    Dayton, Ohio, 45432, United States

  • New Life Medical Research Center

    Hialeah, Florida, 33012, United States

  • Newport Therapeutics

    Newport Beach, California, 92660, United States

  • OSS Health

    York, Pennsylvania, 17402, United States

  • Oasis Clinical Research

    Las Vegas, Nevada, 89121, United States

  • Pain Institute of Southern Arizona

    Tucson, Arizona, 85710, United States

  • Paradigm Health System

    Slidell, Louisiana, 70458, United States

  • Paradigm Research Center/Houston Scoliosis and Spine Institute

    Houston, Texas, 77030, United States

  • Reno Tahoe Pain Associates

    Reno, Nevada, 89511, United States

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • Source Healthcare

    Santa Monica, California, 90403, United States

  • The Kahan Center

    Annapolis, Maryland, 21401, United States

  • TriWest Research Associates

    Chula Vista, California, 91910, United States

  • University of California-Davis Spine Center

    Sacramento, California, 95816, United States

  • University of California-San Francisco

    San Francisco, California, 94143, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Rochester

    Rochester, New York, 14611, United States

  • VA iSpine Physicians

    Richmond, Virginia, 23238, United States

  • Vista Clinical Research

    Newnan, Georgia, 30265, United States

  • West Virginia University

    Martinsburg, West Virginia, 25401, United States

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