Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain
NCT ID: NCT06325566
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
300 participants
INTERVENTIONAL
2024-07-03
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Rexlemestrocel-L + HA
Participants will receive rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with hyaluronic acid (HA) solution on Day 0.
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.
Control Group
Participants will receive saline solution as a sham procedure to simulate the active treatment injection on Day 0.
Saline
Saline solution injection adjacent to the index disc.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Mesoblast, Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Roger D Brown
Role: STUDY_DIRECTOR
Mesoblast, Ltd.
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Paul Pannozzo, MD
Role: primary
Efrain Cubillo, MD
Role: primary
Arthur R Mabaquiao, MD
Role: primary
Kasra Amirdelfan, MD
Role: primary
Philip S Yuan, MD
Role: primary
Rick Paicius, MD
Role: primary
Kee Kim, MD
Role: primary
Krishnan Chakravarthy, MD, PhD
Role: primary
Conor O'Neill, MD
Role: primary
Timothy Davis, MD
Role: primary
Gary Ghiselli, MD
Role: primary
Miguel Telleria, MD, MBA
Role: primary
Anthony Giuffrida, MD
Role: primary
Raul Falero, MD
Role: primary
Ferdinand Formoso, DO
Role: primary
Amir Mahajer, DO
Role: primary
Brent Compton, MD, DC
Role: primary
Anand Patel, MD
Role: primary
Oluseun Olufade, MD
Role: primary
Sandeep Vaid, MD
Role: primary
Jon Carlson, MD
Role: primary
Dawood Sayed, MD
Role: primary
Zeeshan Tayeb, MD
Role: primary
Thomas Myers, MD
Role: primary
Brian Kahan, DO
Role: primary
Ali Nairizi, MD
Role: primary
Ben LaPlante, DO
Role: primary
David B Musante, MD
Role: primary
William "Jeremy" Beckworth, MD
Role: primary
Priyesh Mehta, DO
Role: primary
Douglas P Beall, MD
Role: primary
Carl Balog, MD
Role: primary
Michael B Furman, MD
Role: primary
Alexios Carayannopoulos, DO, MPH
Role: primary
Edward M. Tavel Jr., MD
Role: primary
Mitchell Engle, MD, PhD
Role: primary
Ra'Kerry Rahman, MD
Role: primary
Lance LaFleur, MD, MBA
Role: primary
Michael J DePalma, MD
Role: primary
Other Identifiers
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MSB-DR004
Identifier Type: -
Identifier Source: org_study_id
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