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Clinical Trials in the USA / NCT06325566
Active, not recruiting Phase 3

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

NCT06325566 · tracked via the Priya Life Science USA tracker
Sponsor
Mesoblast, Ltd.
Phase
Phase 3
Started
2024-07-03
Last updated
2026-06-17

Condition(s) studied

Degenerative Disc Disease

Investigational drug(s) / intervention(s)

Rexlemestrocel-L + HA mixtureSaline

Rexlemestrocel-L + HA mixture: Rexlemestrocel-L will be combined in 1:1 by-volume ratio with HA solution and the resulting mixture will be administered as intradiscal injection.

Saline: Saline solution injection adjacent to the index disc.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (40)

FacilityCityRegionStatus
Axsendo Clinical Research/Summa Pain Care Phoenix Arizona
Pain Institute of Southern Arizona Tucson Arizona
TriWest Research Associates Chula Vista California
Boomerang Health Care Concord California
Apex Research Group Fair Oaks California
Memorial Orthopaedic Surgical Group Long Beach California
Newport Therapeutics Newport Beach California
University of California-Davis Spine Center Sacramento California
Innovative Pain Treatment Solutions San Diego California
University of California-San Francisco San Francisco California
Source Healthcare Santa Monica California
Colorado Spine Partners/The Denver Spine and Pain Institute Greenwood Colorado
Cantor Spine Center at the Paley Orthopedic & Spine Institute Fort Lauderdale Florida
New Life Medical Research Center Hialeah Florida
Bold City Clinical Research Jacksonville Florida
Interventional Pain Institute The Villages Florida
Conquest Research LLC Winter Park Florida
Emory Healthcare Dunwoody Georgia
Vista Clinical Research Newnan Georgia
Hawaii Pain & Spine Kailua Hawaii
University of Kansas Medical Center Kansas City Kansas
Iqra Research Edgewood Kentucky
Paradigm Health System Slidell Louisiana
The Kahan Center Annapolis Maryland
Elevate Clinical Research Rockville Maryland
Oasis Clinical Research Las Vegas Nevada
Reno Tahoe Pain Associates Reno Nevada
University of Rochester Rochester New York
Eximia EquiHealth Research LLC/Emerge Ortho Durham North Carolina
AdventHealth Hendersonville Hendersonville North Carolina
Meta Medical Research Institute, LLC Dayton Ohio
Clinical Investigations, LLC Edmond Oklahoma
OSS Health York Pennsylvania
Rhode Island Hospital Providence Rhode Island
Clinical Trials of South Carolina Charleston South Carolina
Institute of Precision Pain Medicine Corpus Christi Texas
Paradigm Research Center/Houston Scoliosis and Spine Institute Houston Texas
Axsendo Clinical Research/Texas Institute of Pain and Spine Pearland Texas
VA iSpine Physicians Richmond Virginia
West Virginia University Martinsburg West Virginia

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06325566 on ClinicalTrials.gov ↗ ← All trials in the USA