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)
Mean Change From Baseline in Daily Average Low Back Pain at 12 Months Post-treatment Based on Visual Analog Scale (VAS) Score — Baseline and Month 12 Low back pain intensity will be measured using a VAS ranging from 0-100 millimeter (mm). A score of 0 represents no pain and 100 represents worst possible pain.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — Up to Month 24
Trial sites (40)
Facility
City
Region
Status
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
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.
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