Degenerative Disc DiseasePhase 3MSB-DR003NCT02412735
Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyaluronic Acid in Participants With Chronic Low Back Pain
A Phase 3 study testing Rexlemestrocel-L and Rexlemestrocel-L + HA Mixture in people with Degenerative Disc Disease, run by Mesoblast, Ltd. at 48 sites in 2 countries.
Trial summary
This is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the safety and efficacy of Mesoblast's rexlemestrocel-L alone or combined with hyaluronic acid (HA) in participants with chronic low back pain (> 6 months) associated with moderate radiographic… 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 and Rexlemestrocel-L + HA Mixture
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 404 participants
- Where
- 48 sitesin 2 countries
- Study dates
- 6 Mar 2015to 15 Jun 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male and female participants 18 years of age and older
- If female of childbearing potential, participant is non-pregnant, non-nursing, and agrees to use highly effective methods of contraception for a minimum of 24 months post-treatment
- Signed informed consent and country-appropriate privacy forms indicating participant is willing to undergo treatment and willing to be available for each examination scheduled over the study duration
- Have documented diagnosis of moderate radiographic degeneration of an intervertebral disc from L1 to S1, with a disc suspected of causing chronic low back pain (CLBP) associated with moderate radiographic degeneration at a lumbar disc is defined as the following (participant must meet all of the listed conditions):
- Chronic low back pain for at least 6 months
- Have failed 6 months of conservative back pain care. (Conservative treatment regimens may include any or all of the following: initial rest, medications [e.g., anti-inflammatory, analgesics, narcotics/opioids, muscle relaxants], massage, acupuncture, chiropractic manipulations, activity modification, home-directed lumbar exercise program, and non-invasive pain control treatments or procedures)
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- Have at a minimum undergone supervised physical therapy, such as daily walking routines, therapeutic exercises, and back education programs specifically for the treatment of low back pain and taken a pain medication for back pain (e.g. non-steroidal anti-inflammatory drug (NSAID) and/or opioid medication).
- Change from normal disc morphology of the index disc as defined by radiographic evaluation by the core imaging evaluation provider. Radiographs must show all of the following:
- A modified Pfirrmann score of 3, 4, 5 or 6 on magnetic resonance imaging (MRI) at the index disc
- Modic Grade II changes or less on MRI at the index disc
- With or without contained disc protrusion at the index disc on MRI
- Low back pain of at least 40mm and not more than 90mm of 100mm on low back pain visual analogue scale (VAS) (average pain over 24 hours)
- Leg pain ≤20mm in both legs on a 100mm VAS scale
- Oswestry disability index (ODI) score of at least 30 and no more than 90 on a 100 point scale.
Who cannot join
- Female participants who are pregnant or nursing, or women planning to become pregnant in the first 24 months post-treatment
- Extreme obesity, as defined by National Institutes of Health (NIH) Clinical Guidelines Body Mass Index (BMI > 40)
- Have undergone a surgical procedure (e.g. discectomy, intradiscal electrothermal therapy, intradiscal radiofrequency, artificial disc replacement, interbody fusion) on the disc at the index or adjacent level
- Osteoporosis, as defined by dual-energy X-ray absorptiometry (DEXA) scan. A DEXA T-score of ≤ -2.5 will exclude the participant.
- Any lumbar intradiscal injection, including steroids, into the index or adjacent discs prior to treatment injection, with the exception of the following injections performed at least 2 weeks prior to study treatment:
- Contrast medium (discography or other diagnostic injection)
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- NSAIDs
- Nerve-blocking anesthetics (e.g., lidocaine, bupivacaine)
- Antibiotics
- Saline
- Have undergone a procedure affecting the structure/biomechanics of the index disc level (e.g., posterolateral fusion)
- Active malignancy or tumor as source of symptoms or history of malignancy within the 5 years prior to enrolment on study
- 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
- An average baseline morphine equivalent dose (MED) of >75mg/day as determined by e-diary entries during the screening period
- Taking systemic immunosuppressants
- A medical condition, serious intercurrent illness, or extenuating circumstance that would preclude participation in the study or potentially decrease survival or interfere with ambulation or rehabilitation.
- Participants involved in spinal litigation, including workman's compensation, unless litigation is complete
- Are transient or has a severe alcohol or substance abuse problem
- Clinically significant nerve pain (e.g., chronic radiculopathy or neuropathy)
- Clinically significant sacroiliac joint pain
- Compressive pathology due to stenosis or disc protrusion on MRI with associated clinical symptoms defined as leg pain VAS>20mm out of 100mm or neurologic deficit on neurologic exam
- Disc extrusion with a maximum dimension greater or equal to twice the posterior height of the disc, or disc sequestration in the lumbar spine on MRI as determined by radiographic core lab
- Modified Pfirrmann score of 7 or 8 at any lumbar level (L1-S1) on MRI evaluation as determined by radiographic core lab
- Symptomatic involvement of more than one lumbar disc
- Symptomatic central vertebral canal stenosis as defined by neurogenic claudication
- Spondylolisthesis or retrolisthesis Grade 2 and above or Spondylolysis at the index or adjacent level(s)
- Lumbar spondylitis or other undifferentiated spondyloarthropathy affecting the index disc
- Spinal deformity defined as lumbar scoliosis with a Cobb angle of the lumbar spine greater than 15 degrees
- Any fracture of the spine at the index or adjacent levels that has not healed, or clinically compromised vertebral bodies at the index level due to current or past trauma
- Facet pain at the index level or adjacent segments as determined by a diagnostic medial branch block (a facet block injection is not acceptable for making this determination) to rule out facet joint involvement.
- Full thickness annular tears in the index level as determined by free flowing contrast media through the annulus fibrosis.
Trial locations and contacts
48 sites in 2 countries.
48 sites in 2 countries
United States47 sites
Emory Orthopaedics & Spine Center
Atlanta, Georgia, 30329
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35235
Millennium Pain Center
Bloomington, Illinois, 61701
Injury Care Medical Center
Boise, Idaho, 83713
Ericksen Research & Development, LLC
Bountiful, Utah, 84010
Clinical Trials of South Carolina
Charleston, South Carolina, 29406
Greenville Pharmaceutical Research, Inc.
Charleston, South Carolina, 29406
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, 28204
Cleveland Clinic
Cleveland, Ohio, 44106
DOC Clinical Research
Dayton, Ohio, 45432
the SMART Clinic
Draper, Utah, 84020
Otrimed Clinical Research
Edgewood, Kentucky, 41017
Clinical Investigations, LLC
Edmond, Oklahoma, 73013
TriWest Research Associates, LLC
El Cajon, California, 92020-4124
Coastal Clinical Research Specialists
Fernandina Beach, Florida, 32034
Shrock Orthopedic Research, LLC
Fort Lauderdale, Florida, 33316
Denver Back Pain Specialists, LLC
Greenwood Village, Colorado, 80111
Tennessee Valley Pain Consultants
Huntsville, Alabama, 35801
Innovative Pain Care Center
Las Vegas, Nevada, 89129
Memorial Orthopaedics Surgical Group
Long Beach, California, 90806
Georgia Institute for Clinical Research, LLC
Marietta, Georgia, 30060
On Site Clinical Solutions, LLC
Morrisville, North Carolina, 28117
Ainsworth Institute of Pain Management
New York, New York, 10022
Newport Beach Headache and Pain
Newport Beach, California, 92660
Holy Cross Orthopedics Institute
Oakland Park, Florida, 33334
Institute for Regenerative Medicine and Clinical Research
Pasadena, California, 91105
Texas Back Institute
Plano, Texas, 75093
RI Hospital-Comprehensive Spine Center
Providence, Rhode Island, 02903
Virginia iSpine Physicians, PC
Richmond, Virginia, 23235
Mayo Clinic
Rochester, Minnesota, 55905
Rochester Regional Health
Rochester, New York, 14626
UC Davis Spine Center
Sacramento, California, 95816
Orthopedic Pain Specialists
Santa Monica, California, 90403
The Spine Institute
Santa Monica, California, 90403
Summit Pain Alliance
Santa Rosa, California, 95401
Arizona Pain Specialists
Scottsdale, Arizona, 85258
MAPS Applied Research Center
Shakopee, Minnesota, 55379
Orthopedic Specialists of Louisiana
Shreveport, Louisiana, 71103
University Clinical Research
Somerset, New Jersey, 08873
Spine Team Texas
Southlake, Texas, 76092
Hope Research Institute
St. George, Utah, 84790
Physicians Research Group
Tempe, Arizona, 85284-2604
Precision Spine Care
Tyler, Texas, 75701
Integrated Pain Management
Walnut Creek, California, 94598
George Washington University Medical Center
Washington D.C., District of Columbia, 20037
The Center for Clinical Research/ Carolinas Pain Institute
Winston-Salem, North Carolina, 27103
Orthopaedic and Spine Specialists
York, Pennsylvania, 17402
About this study
Official title: A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of a Single Injection of Rexlemestrocel-L Alone or Combined With Hyaluronic Acid (HA) in Subjects With Chronic Low Back Pain
This is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the safety and efficacy of Mesoblast's rexlemestrocel-L alone or combined with hyaluronic acid (HA) in participants with chronic low back pain (> 6 months) associated with moderate radiographic degenerative changes of a disc.
- Conditions
- Degenerative Disc Disease
- Being tested
- Rexlemestrocel-L, Rexlemestrocel-L + HA Mixture, Placebo
- Keywords
- Chronic Lumbar Back Pain, Low back pain, Back pain, Degenerative Disc Disease, Injection of Degenerated Lumbar Disc, Intervertebral Disc Degeneration, Bone Diseases, Musculoskeletal Diseases, Nervous System Diseases, Neurologic Manifestations, Pain, Spinal Diseases, Stem Cells, Adult Stem Cells, Allogeneic Mesenchymal Precursor cells (MPCs), Mesoblast, Hyaluronic Acid, Pharmaceutical Solutions, Adjuvants, Immunologic, Immunologic Factors
- Medical subject headings
- Intervertebral Disc Degeneration, Low Back Pain, Back Pain, Bone Diseases, Musculoskeletal Diseases, Nervous System Diseases, Neurologic Manifestations, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rexlemestrocel-LDrug
Rexlemestrocel-L injection
Rexlemestrocel-L + HA MixtureDrug
Rexlemestrocel-L was combined in 1:1 by-volume ratio with HA solution and the resulting mixture was injected
PlaceboDrug
Saline control solution
| Study group | Role | What they receive |
|---|---|---|
| Rexlemestrocel-L | Experimental | Participants received 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 saline on Day 0 (Visit 2). Receives: Drug: Rexlemestrocel-L |
| Rexlemestrocel-L + HA | Experimental | Participants received 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 (Visit 2). Receives: Drug: Rexlemestrocel-L + HA Mixture |
| Placebo | Placebo comparator | Participants received saline solution as matching-placebo on Day 0 (Visit 2). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Treatment Success: Bayesian Estimated Response Rate
Overall treatment success was determined based on number of responders who had composite response at both months 12 and 24 evaluated per specified criteria. A treatment responder with treatment success was defined as a participant who met the 3 criteria of a composite responder analysis as: 50% or greater reduction in the lower-back pain visual analogue scale (VAS) score; 15-point or greater reduction in the Oswestry Disability Index (ODI) score; and lack of post-treatment interventions at the treated level as of the study visit (Visits 6 [12 months post-treatment] and 8 [24 months post-treatment]). The average response rate (proportion of participants with response presented as Bayesian estimate[BE]) was based upon the average of multiple Bayesian simulations.
Measured: Up to 24 months
Secondary outcomes (6)
Effectiveness Based on Pain Responders: Bayesian Estimated Response Rate
A participant was defined as a pain responder for a given study visit if they achieved at least a 50% reduction from Baseline in the lower-back pain VAS score (average pain over 24 hours), as reported during in-clinic assessment. The participant should be qualified as a pain responder at both 12 and 24 months post-treatment, and must not have received a post-treatment intervention through 24 months' follow-up. Any participant that did not have a minimum of a visit at 3 months (Study Visit 4) was considered a non-responder for this outcome measure. The average response rate (proportion of participants with response presented as BE) was based upon the average of multiple Bayesian simulations.
Measured: Up to 24 months
Effectiveness Based on Functional Responders: Bayesian Estimated Response Rate
A participant was defined as a functional responder for a given study visit if they achieved at least a 15-point reduction from Baseline in ODI score, as reported during in-clinic assessment. The participant should be qualified as a functional responder at both 12 and 24 months post-treatment, and must not have received a post-treatment intervention through 24 months' follow-up; any participant that did not have a minimum of a visit at 3 months (Study Visit 4) was considered a non-responder for this outcome measure. The average response rate (proportion of participants with response presented as BE) was based upon the average of multiple Bayesian simulations.
Measured: Up to 24 months
Effectiveness Based on Treatment Success at 24 Months: Bayesian Estimated Response Rate
A treatment responder with treatment success was defined as a participant who met the 3 conditions of a composite responder analysis as: 50% or greater reduction in the lower-back pain VAS score; 15-point or greater reduction in ODI score; and lack of post-treatment interventions at the treated level as of the study visit. The participants qualified as responders if they satisfied the above conditions at the 24-month follow-up visit alone. Any participant that did not have a minimum of a visit at 3 months (Study Visit 4) was considered a non-responder for this outcome measure. The average response rate (proportion of participants with response presented as BE) was based upon the average of multiple Bayesian simulations.
Measured: Month 24
Effectiveness Based on Minimal Pain Responders at 24 Months: Bayesian Estimated Response Rate
A minimal pain responder was defined as a participant who achieved a lower-back pain VAS score (average pain over 24 hours) of 20 mm or less at the given study visit. The participants qualified as responders if they satisfied the above condition at 24 months post-treatment, and did not receive a post-treatment intervention through 24 months' follow-up. Any participant that did not have a minimum of a visit at 3 months (Study Visit 4) was considered a non-responder for this outcome measure. The average response rate (proportion of participants with response presented as BE) was based upon the average of multiple Bayesian simulations.
Measured: Month 24
Effectiveness Based on Time to First Intervention Over 24 Months
The effectiveness of the study drug was evaluated based on its ability in increasing the time to additional interventions at the treated level over 24 months post-treatment. Kaplan-Meier estimates for the probability (expressed as a percentage) of participants to receive an intervention are presented.
Measured: Up to Month 24
Effectiveness Based on Minimal Disability Responders at 24 Months: Bayesian Estimated Response Rate
A minimal disability responder was defined as a participant who achieved an ODI score of 20% or less at the given study visit. The participants qualified as responders if they satisfied the above condition at 24 months post-treatment, and did not receive a post-treatment intervention through 24 months' follow-up. Any participant that did not have a minimum of a visit at 3 months (Study Visit 4) was considered a non-responder for this outcome measure. The average response rate (proportion of participants with response presented as BE) was based upon the average of multiple Bayesian simulations.
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 posted9 Apr 2015 (estimated)
- Study start6 Mar 2015
- Primary completion15 May 2020
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mesoblast, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Responsible party
- Sponsor
- Investigators
- Roger Brown, Study director, Mesoblast, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412735
- Sponsor's protocol ID
- MSB-DR003
- Acronym
- MSB-DR003
- Status last verified
- Sep 2022
- First submitted
- 25 Mar 2015
- Last updated
- 19 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- 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 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of a Single Injection of Rexlemestrocel-L Alone or Combined With Hyaluronic Acid (HA) in Subjects With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT02412735
- Acronym / sponsor ID
- MSB-DR003 / MSB-DR003
- Conditions
- Degenerative Disc Disease
- Keywords
- Chronic Lumbar Back Pain, Low back pain, Back pain, Degenerative Disc Disease, Injection of Degenerated Lumbar Disc, Intervertebral Disc Degeneration, Bone Diseases, Musculoskeletal Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- Mesoblast, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- 6 Mar 2015 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 9 Apr 2015 (estimated)
- Results
- Posted 18 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the safety and efficacy of Mesoblast's rexlemestrocel-L alone or combined with hyaluronic acid (HA) in participants with chronic low back pain (> 6 months) associated with moderate radiographic degenerative changes of a disc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rexlemestrocel-L | Experimental | Drug: Rexlemestrocel-LParticipants received 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 saline on Day 0 (Visit 2). |
| Rexlemestrocel-L + HA | Experimental | Drug: Rexlemestrocel-L + HA MixtureParticipants received 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 (Visit 2). |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received saline solution as matching-placebo on Day 0 (Visit 2). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male and female participants 18 years of age and older
- If female of childbearing potential, participant is non-pregnant, non-nursing, and agrees to use highly effective methods of contraception for a minimum of 24 months post-treatment
- Signed informed consent and country-appropriate privacy forms indicating participant is willing to undergo treatment and willing to be available for each examination scheduled over the study duration
- Have documented diagnosis of moderate radiographic degeneration of an intervertebral disc from L1 to S1, with a disc suspected of causing chronic low back pain (CLBP) associated with moderate radiographic degeneration at a lumbar disc is defined as the following (participant must meet all of the listed conditions):
- A modified Pfirrmann score of 3, 4, 5 or 6 on magnetic resonance imaging (MRI) at the index disc
Key exclusion criteria (31 listed)
- Female participants who are pregnant or nursing, or women planning to become pregnant in the first 24 months post-treatment
- Extreme obesity, as defined by National Institutes of Health (NIH) Clinical Guidelines Body Mass Index (BMI > 40)
- Have undergone a surgical procedure (e.g. discectomy, intradiscal electrothermal therapy, intradiscal radiofrequency, artificial disc replacement, interbody fusion) on the disc at the index or adjacent level
- Osteoporosis, as defined by dual-energy X-ray absorptiometry (DEXA) scan. A DEXA T-score of ≤ -2.5 will exclude the participant.
- Any lumbar intradiscal injection, including steroids, into the index or adjacent discs prior to treatment injection, with the exception of the following injections performed at least 2 weeks prior to study treatment:
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-LRexlemestrocel-L injection | Drug | Rexlemestrocel-L |
| Rexlemestrocel-L + HA MixtureRexlemestrocel-L was combined in 1:1 by-volume ratio with HA solution and the resulting mixture was injected | Drug | Rexlemestrocel-L + HA |
| PlaceboSaline control solution | Drug | Placebo |
Primary outcome
Overall Treatment Success: Bayesian Estimated Response Rate
Time frame: Up to 24 months
Overall treatment success was determined based on number of responders who had composite response at both months 12 and 24 evaluated per specified criteria. A treatment responder with treatment success was defined as a participant who met the 3 criteria of a composite responder analysis as: 50% or greater reduction in the lower-back pain visual analogue scale (VAS) score; 15-point or greater reduction in the Oswestry Disability Index (ODI) score; and lack of post-treatment interventions at the treated level as of the study visit (Visits 6 [12 months post-treatment] and 8 [24 months post-treatment]). The average response rate (proportion of participants with response presented as Bayesian estimate[BE]) was based upon the average of multiple Bayesian simulations.
6 secondary outcomes
Effectiveness Based on Pain Responders: Bayesian Estimated Response Rate
Time frame: Up to 24 months
Effectiveness Based on Functional Responders: Bayesian Estimated Response Rate
Time frame: Up to 24 months
Effectiveness Based on Treatment Success at 24 Months: Bayesian Estimated Response Rate
Time frame: Month 24
Effectiveness Based on Minimal Pain Responders at 24 Months: Bayesian Estimated Response Rate
Time frame: Month 24
Effectiveness Based on Time to First Intervention Over 24 Months
Time frame: Up to Month 24
Effectiveness Based on Minimal Disability Responders at 24 Months: Bayesian Estimated Response Rate
Time frame: Month 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 Brown study director
Mesoblast, Ltd.
48 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rexlemestrocel-L and Rexlemestrocel-L + HA Mixture in people with Degenerative Disc Disease, run by Mesoblast, Ltd. at 48 sites in 2 countries.
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 14 inclusion and 31 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: finished, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Australia. 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?
Yes. Results are posted in the registry (first posted 18 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Treatment Success: Bayesian Estimated Response Rate (time frame: Up to 24 months). 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 19 Oct 2022.