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

Running, not enrolling · Phase 3

Conditions studied: Degenerative Disc Disease

In brief

The primary purpose of this study is to evaluate the efficacy of rexlemestrocel-L+HA compared to control in reducing low back pain at 12 months post-treatment and safety of a single injection of rexlemestrocel-L+HA injected into a lumbar intervertebral disc compared to control through 12 months post-treatment.

Key facts

Study ID

NCT06325566

Run by

Mesoblast, Ltd.

People needed

300

Starts

2024-07-03

Expected to finish

2028-07-01

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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 is running

• Axsendo Clinical Research/Summa Pain Care — Phoenix, Arizona, United States
• Pain Institute of Southern Arizona — Tucson, Arizona, United States
• TriWest Research Associates — Chula Vista, California, United States
• Boomerang Health Care — Concord, California, United States
• Apex Research Group — Fair Oaks, California, United States
• Memorial Orthopaedic Surgical Group — Long Beach, California, United States
• Newport Therapeutics — Newport Beach, California, United States
• University of California-Davis Spine Center — Sacramento, California, United States
• Innovative Pain Treatment Solutions — San Diego, California, United States
• University of California-San Francisco — San Francisco, California, United States
• Source Healthcare — Santa Monica, California, United States
• Colorado Spine Partners/The Denver Spine and Pain Institute — Greenwood, Colorado, United States
• Cantor Spine Center at the Paley Orthopedic & Spine Institute — Fort Lauderdale, Florida, United States
• New Life Medical Research Center — Hialeah, Florida, United States
• Bold City Clinical Research — Jacksonville, Florida, United States
• Interventional Pain Institute — The Villages, Florida, United States
• Conquest Research LLC — Winter Park, Florida, United States
• Emory Healthcare — Dunwoody, Georgia, United States
• Vista Clinical Research — Newnan, Georgia, United States
• Hawaii Pain & Spine — Kailua, Hawaii, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Iqra Research — Edgewood, Kentucky, United States
• Paradigm Health System — Slidell, Louisiana, United States
• The Kahan Center — Annapolis, Maryland, United States
• Elevate Clinical Research — Rockville, Maryland, United States

Full record on ClinicalTrials.gov

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