Degenerative Disc DiseasePhase 3HyaluronicAcidNCT06325566
Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain
A Phase 3 study testing Rexlemestrocel-L + HA mixture and Saline in people with Degenerative Disc Disease, run by Mesoblast, Ltd. at 40 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- Rexlemestrocel-L + HA mixture and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 40 sitesUnited States
- Study dates
- 3 Jul 2024to Jul 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
United States40 sites
The Kahan Center
Annapolis, Maryland, 21401
Clinical Trials of South Carolina
Charleston, South Carolina, 29406
TriWest Research Associates
Chula Vista, California, 91910
Boomerang Health Care
Concord, California, 94520
Institute of Precision Pain Medicine
Corpus Christi, Texas, 78414
Meta Medical Research Institute, LLC
Dayton, Ohio, 45432
Emory Healthcare
Dunwoody, Georgia, 30338
Eximia EquiHealth Research LLC/Emerge Ortho
Durham, North Carolina, 27704
Iqra Research
Edgewood, Kentucky, 41017
Clinical Investigations, LLC
Edmond, Oklahoma, 73034
Apex Research Group
Fair Oaks, California, 95628
Cantor Spine Center at the Paley Orthopedic & Spine Institute
Fort Lauderdale, Florida, 33306
Colorado Spine Partners/The Denver Spine and Pain Institute
Greenwood, Colorado, 80111
AdventHealth Hendersonville
Hendersonville, North Carolina, 28792
New Life Medical Research Center
Hialeah, Florida, 33012
Paradigm Research Center/Houston Scoliosis and Spine Institute
Houston, Texas, 77030
Bold City Clinical Research
Jacksonville, Florida, 32224
Hawaii Pain & Spine
Kailua, Hawaii, 96734
University of Kansas Medical Center
Kansas City, Kansas, 66160
Oasis Clinical Research
Las Vegas, Nevada, 89121
Memorial Orthopaedic Surgical Group
Long Beach, California, 90806
West Virginia University
Martinsburg, West Virginia, 25401
Vista Clinical Research
Newnan, Georgia, 30265
Newport Therapeutics
Newport Beach, California, 92660
Axsendo Clinical Research/Texas Institute of Pain and Spine
Pearland, Texas, 77584
Axsendo Clinical Research/Summa Pain Care
Phoenix, Arizona, 85085
Rhode Island Hospital
Providence, Rhode Island, 02903
Reno Tahoe Pain Associates
Reno, Nevada, 89511
VA iSpine Physicians
Richmond, Virginia, 23238
University of Rochester
Rochester, New York, 14611
Elevate Clinical Research
Rockville, Maryland, 20852
University of California-Davis Spine Center
Sacramento, California, 95816
Innovative Pain Treatment Solutions
San Diego, California, 92111
University of California-San Francisco
San Francisco, California, 94143
Source Healthcare
Santa Monica, California, 90403
Paradigm Health System
Slidell, Louisiana, 70458
Interventional Pain Institute
The Villages, Florida, 32162
Pain Institute of Southern Arizona
Tucson, Arizona, 85710
Conquest Research LLC
Winter Park, Florida, 32789
OSS Health
York, Pennsylvania, 17402
About this study
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
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
- Degenerative Disc Disease
- Being tested
- Rexlemestrocel-L + HA mixture, Saline
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rexlemestrocel-L + HA mixtureDrug
Rexlemestrocel-L will be combined in 1:1 by-volume ratio with HA solution and the resulting mixture will be administered as intradiscal injection.
SalineDrug
Saline solution injection adjacent to the index disc.
| Study group | Role | What they receive |
|---|---|---|
| Rexlemestrocel-L + HA | Experimental | 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. Receives: Drug: Rexlemestrocel-L + HA mixture |
| Control Group | Sham comparator | Participants will receive saline solution as a sham procedure to simulate the active treatment injection on Day 0. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Daily Average Low Back Pain at 12 Months Post-treatment Based on Visual Analog Scale (VAS) Score
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.
Measured: Baseline and Month 12
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Up to Month 24
Secondary outcomes (6)
Percentage of 30% VAS Pain Responders at 12 Months Post-treatment
Responders are defined as participants who have at least a 30% decrease from baseline in daily average low back pain VAS score (measured as the average VAS score over 7 days). VAS score ranges from 0 (no pain) to 100 (worst possible pain).
Measured: Month 12
Mean Change From Baseline in Quality of Life Measured by Euroqol-5D (EQ-5D) Index Score at 12 Months Post-treatment
The EQ-5D is a generic instrument that consists of 5 dimensions: Mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression, rated over five levels of severity ranging from no issues to extreme issues and the responses can be converted into a single number called an index score. The index scores are calculated ranging from 0 (worst quality of life) to 1 (perfect quality of life).
Measured: Baseline and Month 12
Percentage of Minimal Pain Responders at 12 Months Post-treatment
Minimal pain responders are defined as participants who have a low back pain daily average VAS score (measured as the average VAS score over 7 days) of 20 mm or less. VAS score ranges from 0 (no pain) to 100 (worst possible pain).
Measured: Month 12
Mean Change From Baseline in Function as Measured by Oswestry Disability Index (ODI) Questionnaire Score at 12 Months Post-treatment
ODI scores ten aspects of the participant's home and work life and analgesic use in a range of 0 (least amount of disability) to 5 (severe disability). The disability index is then calculated by summing the scores for all questions answered, then multiplied by two and reported in a 0 to 100% range where higher numbers indicate a higher level of disability.
Measured: Baseline and Month 12
Percentage of Participants With 30% VAS and 10-point ODI Treatment Success at 12 Months Post-treatment
Treatment success based on the percentage of participants who have at least a 30% reduction from baseline in daily average low back pain VAS score (measured as the average VAS score over 7 days) with at least a 10-point decrease from baseline ODI score will be reported.
Measured: Month 12
Percentage of Participants Who Ceased Opioid Usage at 24 Months Post-treatment
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start3 Jul 2024
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mesoblast, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roger D Brown, Study director, Mesoblast, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325566
- Sponsor's protocol ID
- MSB-DR004
- Acronym
- HyaluronicAcid
- Status last verified
- Jun 2026
- First submitted
- 15 Mar 2024
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06325566
- Acronym / sponsor ID
- HyaluronicAcid / MSB-DR004
- Conditions
- Degenerative Disc Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Mesoblast, Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rexlemestrocel-L + HA | Experimental | Drug: Rexlemestrocel-L + HA mixtureParticipants 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. |
| Control Group | Sham comparator | Drug: SalineParticipants will receive saline solution as a sham procedure to simulate the active treatment injection on Day 0. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rexlemestrocel-L + HA mixtureRexlemestrocel-L will be combined in 1:1 by-volume ratio with HA solution and the resulting mixture will be administered as intradiscal injection. | Drug | Rexlemestrocel-L + HA |
| SalineSaline solution injection adjacent to the index disc. | Drug | Control Group |
Primary outcome
Mean Change From Baseline in Daily Average Low Back Pain at 12 Months Post-treatment Based on Visual Analog Scale (VAS) Score
Time frame: 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)
Time frame: Up to Month 24
6 secondary outcomes
Percentage of 30% VAS Pain Responders at 12 Months Post-treatment
Time frame: Month 12
Mean Change From Baseline in Quality of Life Measured by Euroqol-5D (EQ-5D) Index Score at 12 Months Post-treatment
Time frame: Baseline and Month 12
Percentage of Minimal Pain Responders at 12 Months Post-treatment
Time frame: Month 12
Mean Change From Baseline in Function as Measured by Oswestry Disability Index (ODI) Questionnaire Score at 12 Months Post-treatment
Time frame: Baseline and Month 12
Percentage of Participants With 30% VAS and 10-point ODI Treatment Success at 12 Months Post-treatment
Time frame: Month 12
Percentage of Participants Who Ceased Opioid Usage at 24 Months Post-treatment
Time frame: Month 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger D Brown study director
Mesoblast, Ltd.
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rexlemestrocel-L + HA mixture and Saline in people with Degenerative Disc Disease, run by Mesoblast, Ltd. at 40 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in Daily Average Low Back Pain at 12 Months Post-treatment Based on Visual Analog Scale (VAS) Score (time frame: Baseline and Month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.