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RECRUITING

NCT06325566

PHASE3

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

Sponsor: Mesoblast, Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2024-07-03

Completion Date

2027-10

Last Updated

2026-01-27

Healthy Volunteers

Conditions

Degenerative Disc Disease

Interventions

DRUG

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.

DRUG

Saline

Saline solution injection adjacent to the index disc.

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.

Locations (39)

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

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

Prime Medical Research

Coral Gables, Florida, 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

OSSO Health, Inc.

Miami Beach, 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

Reno Tahoe Pain Associates

Reno, Nevada, United States

University of Rochester

Rochester, New York, United States

Eximia EquiHealth Research LLC/Emerge Ortho

Durham, North Carolina, United States

AdventHealth Hendersonville

Hendersonville, North Carolina, United States

Meta Medical Research Institute, LLC

Dayton, Ohio, United States

Clinical Investigations, LLC

Edmond, Oklahoma, United States

Axsendo Clinical Research/Compass Pain and Wellness

Portland, Oregon, United States

OSS Health

York, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Clinical Trials of South Carolina

Charleston, South Carolina, United States

Institute of Precision Pain Medicine

Corpus Christi, Texas, United States

Paradigm Research Center/Houston Scoliosis and Spine Institute

Houston, Texas, United States

Axsendo Clinical Research/Texas Institute of Pain and Spine

Pearland, Texas, United States

VA iSpine Physicians

Richmond, Virginia, United States