Actively Recruiting
Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain
Led by Mesoblast, Ltd. · Updated on 2026-01-27
300
Participants Needed
39
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with moderate to severe low back pain lasting at least 6 months who have not improved after at least 3 months of conservative care
- Moderate radiographic degeneration of a single lumbar intervertebral disc from L1 to S1 causing chronic low back pain
You will not qualify if you...
- Prior allogeneic or autologous stem cell or biological therapy to repair the affected disc
- Low back pain lasting less than 6 months or more than 60 months
- Less than 3 months of prior conservative treatment without adequate pain relief
- Current use of systemic immunosuppressants
- Diagnosis of osteoporosis
- Alcohol or substance abuse problems
- Severe depression or anxiety
- Presence of cauda equina syndrome, fibromyalgia, central vertebral canal stenosis, lumbar spondylitis, or related undifferentiated spondyloarthropathy affecting the disc
- Prior surgical procedures affecting the disc or adjacent levels (e.g., discectomy, intradiscal electrothermal therapy, radiofrequency, artificial disc replacement, fusion, laminectomy)
- Lumbar intradiscal injections within 3 months before screening (except contrast medium for discography)
- Epidural steroid injection within 6 weeks before consent
- Neurologic deficits on lumbar neurological exam at baseline
- Sacroiliac joint pain or positive sacroiliac joint injection
- Facet joint pain confirmed by medial branch block
- More than one painful spinal level
- Full thickness annular tear on MRI or discography
- Low back pain less than moderate or extreme in severity
- Lack of moderate to extreme functional limitations or disability
- Other exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 39 locations
1
Axsendo Clinical Research/Summa Pain Care
Phoenix, Arizona, United States, 85085
Actively Recruiting
2
Pain Institute of Southern Arizona
Tucson, Arizona, United States, 85710
Actively Recruiting
3
TriWest Research Associates
Chula Vista, California, United States, 91910
Actively Recruiting
4
Boomerang Health Care
Concord, California, United States, 94520
Actively Recruiting
5
Memorial Orthopaedic Surgical Group
Long Beach, California, United States, 90806
Actively Recruiting
6
Newport Therapeutics
Newport Beach, California, United States, 92660
Actively Recruiting
7
University of California-Davis Spine Center
Sacramento, California, United States, 95816
Actively Recruiting
8
Innovative Pain Treatment Solutions
San Diego, California, United States, 92111
Actively Recruiting
9
University of California-San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
10
Source Healthcare
Santa Monica, California, United States, 90403
Actively Recruiting
11
Colorado Spine Partners/The Denver Spine and Pain Institute
Greenwood, Colorado, United States, 80111
Actively Recruiting
12
Prime Medical Research
Coral Gables, Florida, United States, 33134
Actively Recruiting
13
Cantor Spine Center at the Paley Orthopedic & Spine Institute
Fort Lauderdale, Florida, United States, 33306
Actively Recruiting
14
New Life Medical Research Center
Hialeah, Florida, United States, 33012
Actively Recruiting
15
Bold City Clinical Research
Jacksonville, Florida, United States, 32224
Actively Recruiting
16
OSSO Health, Inc.
Miami Beach, Florida, United States, 33140
Actively Recruiting
17
Interventional Pain Institute
The Villages, Florida, United States, 32162
Actively Recruiting
18
Conquest Research LLC
Winter Park, Florida, United States, 32789
Actively Recruiting
19
Emory Healthcare
Dunwoody, Georgia, United States, 30338
Actively Recruiting
20
Vista Clinical Research
Newnan, Georgia, United States, 30265
Actively Recruiting
21
Hawaii Pain & Spine
Kailua, Hawaii, United States, 96734
Actively Recruiting
22
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
23
Iqra Research
Edgewood, Kentucky, United States, 41017
Actively Recruiting
24
Paradigm Health System
Slidell, Louisiana, United States, 70458
Actively Recruiting
25
The Kahan Center
Annapolis, Maryland, United States, 21401
Actively Recruiting
26
Reno Tahoe Pain Associates
Reno, Nevada, United States, 89511
Actively Recruiting
27
University of Rochester
Rochester, New York, United States, 14611
Actively Recruiting
28
Eximia EquiHealth Research LLC/Emerge Ortho
Durham, North Carolina, United States, 27704
Actively Recruiting
29
AdventHealth Hendersonville
Hendersonville, North Carolina, United States, 28792
Actively Recruiting
30
Meta Medical Research Institute, LLC
Dayton, Ohio, United States, 45432
Actively Recruiting
31
Clinical Investigations, LLC
Edmond, Oklahoma, United States, 73034
Actively Recruiting
32
Axsendo Clinical Research/Compass Pain and Wellness
Portland, Oregon, United States, 97201
Actively Recruiting
33
OSS Health
York, Pennsylvania, United States, 17402
Actively Recruiting
34
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
35
Clinical Trials of South Carolina
Charleston, South Carolina, United States, 29406
Actively Recruiting
36
Institute of Precision Pain Medicine
Corpus Christi, Texas, United States, 78414
Actively Recruiting
37
Paradigm Research Center/Houston Scoliosis and Spine Institute
Houston, Texas, United States, 77030
Actively Recruiting
38
Axsendo Clinical Research/Texas Institute of Pain and Spine
Pearland, Texas, United States, 77584
Actively Recruiting
39
VA iSpine Physicians
Richmond, Virginia, United States, 23238
Actively Recruiting
Research Team
R
Roger D Brown
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here