Degenerative Disc DiseasePhase 2NCT00996073
Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion
A Phase 2 study testing Lumbar Interbody Fusion with Autograft and Lumbar Interbody Fusion with NeoFuse in people with Degenerative Disc Disease and Degenerative Spondylolisthesis, run by Mesoblast, Ltd. at 5 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and preliminary efficacy of NeoFuse in subjects with a diagnosis of degenerative disc disease (DDD) in 1 or 2 adjacent vertebral levels between L1 and S1. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Spinal Stenosis
- What is being tested?
- Lumbar Interbody Fusion with Autograft and Lumbar Interbody Fusion with NeoFuse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2009to Jul 2014
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or females at least 18 years of age, but not older than 70.
- 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 a documented symptomatic diagnosis of DDD at L1-S1 with or without stenosis and with or without up to and including Grade II degenerative spondylolisthesis.
- Have clinical symptoms of neurogenic claudication.
- Have failed 6 months of non-operative low back pain management.
- Are candidates for posterior lumbar interbody fusion in combination with posterior pedicle screw stabilization and require surgery at a 1 or 2 adjacent vertebral levels between L1 and S1.
- Have a stable screening electrocardiogram (ECG), as determined by the investigator that would not preclude surgery.
Who cannot join
- Female subjects who are pregnant or nursing, or women planning to become pregnant during the first year (12 months) following surgery.
- Male subjects with partners of childbearing potential must agree to use adequate contraception (barrier method or abstinence) from the time of surgery and for a period of at least 1 year after 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.
- Have osteoporosis as defined by a DEXA T score of ≤ -3.0 or a history of fragility fractures or other significant bone disease contraindicating the use of spinal instrumentation.
- Have a documented medical history or radiographic evidence of a metabolic bone disease or other condition which would negatively impact the bone healing process.
- Have a positive screen for human immunodeficiency virus (HIV) antibodies.
Show all 11Show fewer
- Have had treatment with any investigational therapy or device within 6 months of study surgery and/or plans to participate in any other allogeneic stem cell/progenitor cell therapy trial during the 3-year follow-up period.
- Have been a recipient of prior stem cell/progenitor cell therapy for spinal fusion surgery.
- Have a body mass index (BMI) > 35.
- Have 20% or greater anti-human leukocyte antigen (HLA) antibody titer and/or has antibody specificities to donor HLA antigens.
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Central Texas Spine Institute
Austin, Texas, 78731
Fort Wayne Orthopaedics
Fort Wayne, Indiana, 46804
Denver Spine
Greenwood Village, Colorado, 80111
Rocky Mountain Associates in Orthopedic Medicine, P.C.
Loveland, Colorado, 80538
The Spine Institute
Santa Monica, California, 90404
About this study
Official title: A Prospective, Multicenter, Randomized, Open-Label, Controlled Study Evaluating Safety and Preliminary Efficacy of NeoFuse When Combined With MasterGraft Matrix in Subjects Undergoing Lumbar Interbody Fusion With Instrumentation
The purpose of this study is to evaluate the safety and preliminary efficacy of NeoFuse in subjects with a diagnosis of degenerative disc disease (DDD) in 1 or 2 adjacent vertebral levels between L1 and S1. All subjects in this study will undergo interbody fusion via Transforaminal Lumbar Interbody Fusion (TLIF) or Posterior Lumbar Interbody Fusion (PLIF) procedures with Food and Drug Administration (FDA) approved/cleared supplemental posterior instrumentation.
Read the detailed description
This is a prospective, multicenter, randomized, open-label controlled Phase 2 study designed to evaluate the safety and preliminary efficacy of adult, allogeneic mesenchymal precursor cells (MPCs) combined with MasterGraft Matrix when compared to use of autologous iliac crest bone graft in the lumbar interbody fusion site in subjects requiring 1 or 2 level interbody fusion procedure with instrumentation. All subjects in this study will undergo a 1 or 2-level (2 or 3 vertebrae) interbody fusion with supplemental posterior instrumentation.
After the screening and surgical visits, each subject will be evaluated clinically and radiographically within 3 days and 30 days after surgery, and at 3, 6, 9, 12, 24, and 36 months after surgery.
Subjects will be evaluated at the same time points for safety.
- Being tested
- Lumbar Interbody Fusion with Autograft, Lumbar Interbody Fusion with NeoFuse
- Keywords
- Degenerative disc disease, Spondylolisthesis, Spinal stenosis, Stem cells, Adult Stem Cells, Spinal Fusion, Lumbar Spinal Fusion, TLIF, PLIF, Mesoblast
- Medical subject headings
- Intervertebral Disc Degeneration, Spinal Stenosis, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar Interbody Fusion with AutograftBiological
Also called Spinal Fusion, Control
Single Dose Autograft Surgical Implantation
Lumbar Interbody Fusion with NeoFuseBiological
Also called Spinal Fusion, Stem Cells
Single Dose NeoFuse Surgical Implantation
Lumbar Interbody Fusion with NeoFuseBiological
Also called Spinal Fusion, Stem Cells
Single Dose NeoFuse Surgical Implantation
| Study group | Role | What they receive |
|---|---|---|
| Autograft | Active comparator | Lumbar Interbody Fusion with Autograft Receives: Biological: Lumbar Interbody Fusion with Autograft |
| Low Dose | Experimental | Lumbar Interbody Fusion with NeoFuse-Low Dose Receives: Biological: Lumbar Interbody Fusion with NeoFuse |
| High Dose | Experimental | Lumbar Interbody Fusion with NeoFuse-High Dose Receives: Biological: Lumbar Interbody Fusion with NeoFuse |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the overall safety of NeoFuse 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 (1)
To evaluate the overall fusion success with NeoFuse plus carrier compared to autograft using CT scans and x-ray of the involved lumbar spine levels and assess the change in outcomes (ODI, SF-36, and WPAI) and pain (VAS)at the 12-month follow-up visit.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionJul 2012
- Study completionJul 2014
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mesoblast, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roger Brown, Study director, Senior Vice President of Musculoskeletal Repair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00996073
- Sponsor's protocol ID
- MSB-SF003
- Status last verified
- Jun 2020
- First submitted
- 9 Oct 2009
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Open-Label, Controlled Study Evaluating Safety and Preliminary Efficacy of NeoFuse When Combined With MasterGraft Matrix in Subjects Undergoing Lumbar Interbody Fusion With Instrumentation
- ClinicalTrials.gov ID
- NCT00996073
- Acronym / sponsor ID
- MSB-SF003
- Keywords
- Degenerative disc disease, Spondylolisthesis, Spinal stenosis, Stem cells, Adult Stem Cells, Spinal Fusion, Lumbar Spinal Fusion, TLIF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mesoblast, Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 16 Oct 2009 (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 evaluate the safety and preliminary efficacy of NeoFuse in subjects with a diagnosis of degenerative disc disease (DDD) in 1 or 2 adjacent vertebral levels between L1 and S1. All subjects in this study will undergo interbody fusion via Transforaminal Lumbar Interbody Fusion (TLIF) or Posterior Lumbar Interbody Fusion (PLIF) procedures with Food and Drug Administration (FDA) approved/cleared supplemental posterior instrumentation.
Detailed description
This is a prospective, multicenter, randomized, open-label controlled Phase 2 study designed to evaluate the safety and preliminary efficacy of adult, allogeneic mesenchymal precursor cells (MPCs) combined with MasterGraft Matrix when compared to use of autologous iliac crest bone graft in the lumbar interbody fusion site in subjects requiring 1 or 2 level interbody fusion procedure with instrumentation. All subjects in this study will undergo a 1 or 2-level (2 or 3 vertebrae) interbody fusion with supplemental posterior instrumentation.
After the screening and surgical visits, each subject will be evaluated clinically and radiographically within 3 days and 30 days after surgery, and at 3, 6, 9, 12, 24, and 36 months after surgery.
Subjects will be evaluated at the same time points for safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Autograft | Active comparator | Biological: Lumbar Interbody Fusion with AutograftLumbar Interbody Fusion with Autograft |
| Low Dose | Experimental | Biological: Lumbar Interbody Fusion with NeoFuseLumbar Interbody Fusion with NeoFuse-Low Dose |
| High Dose | Experimental | Biological: Lumbar Interbody Fusion with NeoFuseLumbar Interbody Fusion with NeoFuse-High Dose |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or females at least 18 years of age, but not older than 70.
- 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 a documented symptomatic diagnosis of DDD at L1-S1 with or without stenosis and with or without up to and including Grade II degenerative spondylolisthesis.
- Have clinical symptoms of neurogenic claudication.
Key exclusion criteria (11 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.
- Have osteoporosis as defined by a DEXA T score of ≤ -3.0 or a history of fragility fractures or other significant bone disease contraindicating the use of spinal instrumentation.
- Have a documented medical history or radiographic evidence of a metabolic bone disease or other condition which would negatively impact the bone healing process.
- Have a positive screen for human immunodeficiency virus (HIV) antibodies.
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 |
|---|---|---|
| Lumbar Interbody Fusion with AutograftAlso: Spinal Fusion, ControlSingle Dose Autograft Surgical Implantation | Biological | Autograft |
| Lumbar Interbody Fusion with NeoFuseAlso: Spinal Fusion, Stem CellsSingle Dose NeoFuse Surgical Implantation | Biological | Low Dose |
| Lumbar Interbody Fusion with NeoFuseAlso: Spinal Fusion, Stem CellsSingle Dose NeoFuse Surgical Implantation | Biological | High Dose |
Primary outcome
To determine the overall safety of NeoFuse 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
1 secondary outcome
To evaluate the overall fusion success with NeoFuse plus carrier compared to autograft using CT scans and x-ray of the involved lumbar spine levels and assess the change in outcomes (ODI, SF-36, and WPAI) and pain (VAS)at the 12-month follow-up visit.
Time frame: 3 years
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 29 Jun 2020.
- The Sponsor's web siteLink provided by the sponsor.
Related trials for Degenerative Disc Disease
Not yet recruiting
CANLINK: Evaluation of the Intralink Intradiscal Device for Low Back Pain Due to Degenerative Disc Disease
Degenerative Disc Disease(DDD)
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Active, not recruiting
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
Cervical Degenerative Disc Disease
Active, not recruiting
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Degenerative Disc Disease, Disc Degeneration
RecruitingObservational study
OssDsign® Spine Registry Study ("Propel")
Degenerative Disc Disease, Spinal Stenosis
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
Senior Vice President of Musculoskeletal Repair
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lumbar Interbody Fusion with Autograft and Lumbar Interbody Fusion with NeoFuse in people with Degenerative Disc Disease and Degenerative Spondylolisthesis, run by Mesoblast, Ltd. at 5 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 8 inclusion and 11 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 29 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 5 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. 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 NeoFuse 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 29 Jun 2020; AzTrials last refreshed its copy on 7 Nov 2026.