Degenerative Disc DiseasePhase 2NCT01290367
Safety and Preliminary Efficacy Study of Mesenchymal Precursor Cells (MPCs) in Subjects With Lumbar Back Pain
A Phase 2 study testing Single Dose MPCs Injection, Single injection of saline solution and Single injection of hyaluronic acid in people with Degenerative Disc Disease, run by Mesoblast, Ltd. at 14 sites in 2 countries.
Trial summary
The purpose of this study is to compare two doses of immunoselected, culture-expanded, nucleated, allogeneic adult MPCs when combined with hyaluronic acid to two control intradiscal injections in subjects with chronic low back pain due to moderate Degenerative Disc Disease (DDD) at one lumbar level from L1 to S1. 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?
- Single Dose MPCs Injection, Single injection of saline solution and Single injection of hyaluronic acid
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Aug 2011to Jul 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 or females at least 18 years of age.
- Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol.
- Have the ability to understand and provide written authorization for the use and disclosure of personal health information (PHI) [per Health Insurance Portability and Accountability Act (HIPAA) privacy ruling in the US].
- Have chronic low back pain for at least 6 months.
- Have documented symptomatic diagnosis of DDD of one level from L1-S1 as determined by a change in disc hydration on MRI compared to normal disc with or without an annular fissure or a contained disc herniation.
- Have failed 3 months of non-operative low back pain management.
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- Disc height loss of <30% compared to a normal adjacent disc based upon radiographic evaluation.
- Pre-treatment baseline low back pain of at least 40 mm on a 100 mm visual analog scale.
- Low back pain greater than leg pain.
- Pre-treatment baseline Oswestry Disability Index Questionnaire score of at least 30 on the 100-point questionnaire.
Who cannot join
- Female subjects who are pregnant or nursing, or women planning to become pregnant during the first year (12 months) following surgery.
- Have a current or prior history within the last 3 years of neoplasm (excluding basal cell carcinoma) and/or any active neoplasm within the last 24 months, prior to screening.
- Patients with compressive pathology due to stenosis or frankly herniated disc or sequestered discs are not candidates.
- Intact disc bulge/protrusion or focal herniation at the symptomatic level (s) > 3 mm or presence of disc extrusion or sequestration.
- Lumbar spondylitis or other undifferentiated spondyloarthropathy.
- Have undergone a previous surgery at the involved levels.
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- Any lumbar intradiscal injection procedure (e.g., injection of corticosteroids, methylene blue, dextrose, or glucosamine and chondroitin sulfate). Discography may be performed, but must be done at least 2 weeks or more prior to the MPC injection procedure.
- Have an acute fracture of the spine at the time of enrollment in the study.
- Have a history of epidural steroid injections within 1 week prior to study treatment.
- Have a known history of hypersensitivity or anaphylactic reaction to murine or bovine products or dimethyl sulfoxide (DMSO).
- Have a positive screen for human immunodeficiency virus (HIV) antibodies.
- Have a known history of hypersensitivity or anaphylactic reaction to Hyaluronan.
- Have a current or prior history within the last 3 years of neoplasm (excluding basal cell carcinoma) and/or any active neoplasm within the last 24 months, prior to screening.
- Have been a recipient of prior stem cell/progenitor cell therapy or other biological intervention to repair the target intervertebral disc.
- Are transient or has been treated in the last 6 months before enrollment for alcohol and/or drug abuse in an inpatient substance abuse program.
- Currently incarcerated (prisoners).
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States13 sites
Emory University School of Medicine
Atlanta, Georgia, 30329
Central Texas Spine Institute
Austin, Texas, 78731
The Center for Pain Relief, Inc.
Charleston, West Virginia, 25301
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, 28204
Denver Spine
Denver, Colorado, 80111
Washington Center for Pain Management
Edmonds, Washington, 98026
Rocky Mountain Associates in Orthopedic Medicine, P.C.
Loveland, Colorado, 80538
Richmond Bone and Joint Clinic, Memorial Hermann Medical Group
Richmond, Texas, 77469
Virginia Spine Research Institute, Inc.
Richmond, Virginia, 23235
UC Davis Spine Center
Sacramento, California, 95816
The Spine Institute
Santa Monica, California, 90403
Arizona Pain Specialists
Scottsdale, Arizona, 85258
IPM Medical Group, Inc.
Walnut Creek, California, 94598
About this study
Official title: A Prospective, Double Blind, Controlled Study Evaluating Safety and Preliminary Efficacy of a Single Injection of Adult Mesenchymal Precursor Cells (MPCs) Combined With Hyaluronan in Subjects With Chronic Discogenic Lumbar Back Pain
The purpose of this study is to compare two doses of immunoselected, culture-expanded, nucleated, allogeneic adult MPCs when combined with hyaluronic acid to two control intradiscal injections in subjects with chronic low back pain due to moderate Degenerative Disc Disease (DDD) at one lumbar level from L1 to S1.
All investigational subjects in this study will undergo injection of either 6 million (M) or 18M cells in a hyaluronic acid carrier into the degenerated lumbar disc's nucleus pulposus. All control subjects will undergo an intradiscal control injection with either saline or hyaluronic acid only
Read the detailed description
This is a prospective, multicenter, double blinded, controlled clinical study comparing two doses of immunoselected, culture-expanded, nucleated, allogeneic adult MPCs when combined with hyaluronic acid to two control intradiscal injections in subjects with chronic low back pain (> 6 months) due to moderate DDD at one lumbar level from L1 to S1 and unresponsive to conservative therapy for at least 3 months (including physical therapy).
After the screening and injection visits, each subject will be evaluated clinically and radiographically at 30 days, and again at 3, 6, 12, 24 and 36 months after injection.
Subjects will be evaluated at the same time points for safety.
- Conditions
- Degenerative Disc Disease
- Being tested
- Single Dose MPCs Injection, Single injection of saline solution, Single injection of hyaluronic acid
- Keywords
- Chronic Lumbar Back Pain, Low back pain, Back pain, Degenerative Disc Disease, Injection of Degenerated Lumbar Disc, Stem Cells, Adult Stem Cells, Allogeneic Mesenchymal Precursor cells (MPCs), Mesoblast
- Medical subject headings
- Intervertebral Disc Degeneration, Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Dose MPCs InjectionBiological
Also called Direct MPCs Lumbar Disc Injection., Stem Cells
Injection of Low Dose MPCs with Hyaluronic Acid into the degenerated lumbar disc's nucleus pulposus.
Single injection of saline solutionProcedure or surgery
Also called Saline injection, Sham control
Intradiscal control injection with saline solution
Single injection of hyaluronic acidProcedure or surgery
Also called Hyaluronic acid injection, Vehicle control
Intradiscal control injection with hyaluronic acid
Single Dose MPCs InjectionBiological
Also called Stem Cells
Injection of HighDose MPCs with Hyaluronic Acid into the degenerated lumbar disc's nucleus pulposus.
| Study group | Role | What they receive |
|---|---|---|
| High Dose MPCs | Experimental | Injection of High Dose MPCs with Hyaluronic Acid Receives: Biological: Single Dose MPCs Injection |
| Low Dose MPCs | Experimental | Injection of Low Dose MPCs with Hyaluronic Acid Receives: Biological: Single Dose MPCs Injection |
| Saline injection | Sham comparator | Injection of saline solution. Receives: Procedure: Single injection of saline solution |
| Hyaluronic acid injection | Placebo comparator | Injection of hyaluronic acid solution Receives: Procedure: Single injection of hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the overall safety of MPCs plus carrier using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests (hematology, serum chemistry, inflammation, and immunology).
Measured: 3 years
Secondary outcomes (2)
To evaluate the change of treated lumbar intervertebral discs using Magnetic Resonance Imaging (MRI) at 6 months post injection of MPCs.
Measured: 6 - 36 Months
To evaluate the effectiveness of MPCs in reducing chronic lumbar back pain using the visual analog scale (VAS).
Measured: 1 - 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2011 (estimated)
- Study startAug 2011
- Primary completionJul 2013
- Study completionJul 2015
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mesoblast, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roger Brown, Study director, Mesoblast, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01290367
- Sponsor's protocol ID
- MSB-DR001
- Status last verified
- Jun 2020
- First submitted
- 3 Feb 2011
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double Blind, Controlled Study Evaluating Safety and Preliminary Efficacy of a Single Injection of Adult Mesenchymal Precursor Cells (MPCs) Combined With Hyaluronan in Subjects With Chronic Discogenic Lumbar Back Pain
- ClinicalTrials.gov ID
- NCT01290367
- Acronym / sponsor ID
- MSB-DR001
- Conditions
- Degenerative Disc Disease
- Keywords
- Chronic Lumbar Back Pain, Low back pain, Back pain, Degenerative Disc Disease, Injection of Degenerated Lumbar Disc, Stem Cells, Adult Stem Cells, Allogeneic Mesenchymal Precursor cells (MPCs)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mesoblast, Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 7 Feb 2011 (estimated)
- 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 purpose of this study is to compare two doses of immunoselected, culture-expanded, nucleated, allogeneic adult MPCs when combined with hyaluronic acid to two control intradiscal injections in subjects with chronic low back pain due to moderate Degenerative Disc Disease (DDD) at one lumbar level from L1 to S1.
All investigational subjects in this study will undergo injection of either 6 million (M) or 18M cells in a hyaluronic acid carrier into the degenerated lumbar disc's nucleus pulposus. All control subjects will undergo an intradiscal control injection with either saline or hyaluronic acid only
Detailed description
This is a prospective, multicenter, double blinded, controlled clinical study comparing two doses of immunoselected, culture-expanded, nucleated, allogeneic adult MPCs when combined with hyaluronic acid to two control intradiscal injections in subjects with chronic low back pain (> 6 months) due to moderate DDD at one lumbar level from L1 to S1 and unresponsive to conservative therapy for at least 3 months (including physical therapy).
After the screening and injection visits, each subject will be evaluated clinically and radiographically at 30 days, and again at 3, 6, 12, 24 and 36 months after injection.
Subjects will be evaluated at the same time points for safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High Dose MPCs | Experimental | Biological: Single Dose MPCs InjectionInjection of High Dose MPCs with Hyaluronic Acid |
| Low Dose MPCs | Experimental | Biological: Single Dose MPCs InjectionInjection of Low Dose MPCs with Hyaluronic Acid |
| Saline injection | Sham comparator | Procedure: Single injection of saline solutionInjection of saline solution. |
| Hyaluronic acid injection | Placebo comparator | Procedure: Single injection of hyaluronic acidInjection of hyaluronic acid solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or females at least 18 years of age.
- Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol.
- Have the ability to understand and provide written authorization for the use and disclosure of personal health information (PHI) [per Health Insurance Portability and Accountability Act (HIPAA) privacy ruling in the US].
- Have chronic low back pain for at least 6 months.
- Have documented symptomatic diagnosis of DDD of one level from L1-S1 as determined by a change in disc hydration on MRI compared to normal disc with or without an annular fissure or a contained disc herniation.
Key exclusion criteria (16 listed)
- Female subjects who are pregnant or nursing, or women planning to become pregnant during the first year (12 months) following surgery.
- Have a current or prior history within the last 3 years of neoplasm (excluding basal cell carcinoma) and/or any active neoplasm within the last 24 months, prior to screening.
- Patients with compressive pathology due to stenosis or frankly herniated disc or sequestered discs are not candidates.
- Intact disc bulge/protrusion or focal herniation at the symptomatic level (s) > 3 mm or presence of disc extrusion or sequestration.
- Lumbar spondylitis or other undifferentiated spondyloarthropathy.
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 |
|---|---|---|
| Single Dose MPCs InjectionAlso: Direct MPCs Lumbar Disc Injection., Stem CellsInjection of Low Dose MPCs with Hyaluronic Acid into the degenerated lumbar disc's nucleus pulposus. | Biological | High Dose MPCs, Low Dose MPCs |
| Single injection of saline solutionAlso: Saline injection, Sham controlIntradiscal control injection with saline solution | Procedure or surgery | Saline injection |
| Single injection of hyaluronic acidAlso: Hyaluronic acid injection, Vehicle controlIntradiscal control injection with hyaluronic acid | Procedure or surgery | Hyaluronic acid injection |
| Single Dose MPCs InjectionAlso: Stem CellsInjection of HighDose MPCs with Hyaluronic Acid into the degenerated lumbar disc's nucleus pulposus. | Biological | High Dose MPCs, Low Dose MPCs |
Primary outcome
To determine the overall safety of MPCs plus carrier using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests (hematology, serum chemistry, inflammation, and immunology).
Time frame: 3 years
2 secondary outcomes
To evaluate the change of treated lumbar intervertebral discs using Magnetic Resonance Imaging (MRI) at 6 months post injection of MPCs.
Time frame: 6 - 36 Months
To evaluate the effectiveness of MPCs in reducing chronic lumbar back pain using the visual analog scale (VAS).
Time frame: 1 - 36 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
- Sponsor WebsiteLink provided by the sponsor.
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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.
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Single Dose MPCs Injection, Single injection of saline solution and Single injection of hyaluronic acid in people with Degenerative Disc Disease, run by Mesoblast, Ltd. at 14 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 10 inclusion and 16 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 26 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the overall safety of MPCs plus carrier using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests (hematology, serum chemistry, inflammation, and immunology). (time frame: 3 years). 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 26 Jun 2020.