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

Purpose

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.

Condition

  • Degenerative Disc Disease

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • 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.
Sham Comparator
Control Group 		Participants will receive saline solution as a sham procedure to simulate the active treatment injection on Day 0.
  • Drug: Saline
    Saline solution injection adjacent to the index disc.

Recruiting Locations

Axsendo Clinical Research/Summa Pain Care
Phoenix, Arizona 85085
Contact:
Paul Pannozzo, MD

Pain Institute of Southern Arizona
Tucson, Arizona 85710
Contact:
Efrain Cubillo, MD

TriWest Research Associates
Chula Vista, California 91910
Contact:
Arthur R Mabaquiao, MD

Boomerang Health Care
Concord, California 94520
Contact:
Kasra Amirdelfan, MD

Memorial Orthopaedic Surgical Group
Long Beach, California 90806
Contact:
Philip S Yuan, MD

Newport Therapeutics
Newport Beach, California 92660
Contact:
Rick Paicius, MD

University of California-Davis Spine Center
Sacramento, California 95816
Contact:
Kee Kim, MD

Innovative Pain Treatment Solutions
San Diego, California 92111
Contact:
Krishnan Chakravarthy, MD, PhD

University of California-San Francisco
San Francisco, California 94143
Contact:
Conor O'Neill, MD

Source Healthcare
Santa Monica, California 90403
Contact:
Timothy Davis, MD

Colorado Spine Partners/The Denver Spine and Pain Institute
Greenwood, Colorado 80111
Contact:
Gary Ghiselli, MD

Prime Medical Research
Coral Gables, Florida 33134
Contact:
Miguel Telleria, MD, MBA

Cantor Spine Center at the Paley Orthopedic & Spine Institute
Fort Lauderdale, Florida 33306
Contact:
Anthony Giuffrida, MD

New Life Medical Research Center
Hialeah, Florida 33012
Contact:
Raul Falero, MD

Bold City Clinical Research
Jacksonville, Florida 32224
Contact:
Ferdinand Formoso, DO

OSSO Health, Inc.
Miami Beach, Florida 33140
Contact:
Amir Mahajer, DO

Interventional Pain Institute
The Villages, Florida 32162
Contact:
Brent Compton, MD, DC

Conquest Research LLC
Winter Park, Florida 32789
Contact:
Anand Patel, MD

Emory Healthcare
Dunwoody, Georgia 30338
Contact:
Oluseun Olufade, MD

Vista Clinical Research
Newnan, Georgia 30265
Contact:
Sandeep Vaid, MD

Hawaii Pain & Spine
Kailua, Hawaii 96734
Contact:
Jon Carlson, MD

University of Kansas Medical Center
Kansas City, Kansas 66160
Contact:
Dawood Sayed, MD

Iqra Research
Edgewood, Kentucky 41017
Contact:
Zeeshan Tayeb, MD

Paradigm Health System
Slidell, Louisiana 70458
Contact:
Thomas Myers, MD

The Kahan Center
Annapolis, Maryland 21401
Contact:
Brian Kahan, DO

Reno Tahoe Pain Associates
Reno, Nevada 89511
Contact:
Ali Nairizi, MD

University of Rochester
Rochester, New York 14611
Contact:
Ben LaPlante, DO

Eximia EquiHealth Research LLC/Emerge Ortho
Durham, North Carolina 27704
Contact:
David B Musante, MD

AdventHealth Hendersonville
Hendersonville, North Carolina 28792
Contact:
William "Jeremy" Beckworth, MD

Meta Medical Research Institute, LLC
Dayton, Ohio 45432
Contact:
Priyesh Mehta, DO

Clinical Investigations, LLC
Edmond, Oklahoma 73034
Contact:
Douglas P Beall, MD

Axsendo Clinical Research/Compass Pain and Wellness
Portland, Oregon 97201
Contact:
Carl Balog, MD

OSS Health
York, Pennsylvania 17402
Contact:
Michael B Furman, MD

Rhode Island Hospital
Providence, Rhode Island 02903
Contact:
Alexios Carayannopoulos, DO, MPH

Clinical Trials of South Carolina
Charleston, South Carolina 29406
Contact:
Edward M. Tavel Jr., MD

Institute of Precision Pain Medicine
Corpus Christi, Texas 78414
Contact:
Mitchell Engle, MD, PhD

Paradigm Research Center/Houston Scoliosis and Spine Institute
Houston, Texas 77030
Contact:
Ra'Kerry Rahman, MD

Axsendo Clinical Research/Texas Institute of Pain and Spine
Pearland, Texas 77584
Contact:
Lance LaFleur, MD, MBA

VA iSpine Physicians
Richmond, Virginia 23238
Contact:
Michael J DePalma, MD

More Details

NCT ID
NCT06325566
Status
Recruiting
Sponsor
Mesoblast, Ltd.

Study Contact

Roger D Brown
1 212 880 2060
clinical@mesoblast.com

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center