Degenerative Disc DiseasePhase 1/2NCT00810212
Safety and Efficacy Study of NeoFuse in Subjects Requiring Posterolateral Lumbar Fusion
A Phase 1/2 study testing PLF with autograft and PLF with NeoFuse in people with Degenerative Disc Disease and Degenerative Spondylolisthesis, run by Mesoblast, Ltd. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate safety and preliminary efficacy of Neofusetm in subjects with a diagnosis of degenerative disc disease (DDD) in 1 or 2 adjacent vertebral levels between L1 and S1 and undergoing posterolateral lumbar fusion. 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?
- PLF with autograft and PLF with NeoFuse
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Nov 2011
- Phase
- Phase 1/2
- 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 or applicable regulations outside 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 lumbar interbody fusion with autograft in combination with posterolateral fusion 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.
- 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 ≤ -3.5 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
- 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.
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- 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
1 site in 1 country.
About this study
Official title: A Prospective, Multicenter, Randomized, Open-Label, Controlled Study Evaluating Safety and Preliminary Efficacy of NeoFuse When Combined With Mastergraft Granules in Subjects Undergoing Posterolateral Lumbar Fusion With Instrumentation
The purpose of this study is to evaluate safety and preliminary efficacy of Neofusetm in subjects with a diagnosis of degenerative disc disease (DDD) in 1 or 2 adjacent vertebral levels between L1 and S1 and undergoing posterolateral lumbar fusion.
Read the detailed description
This is a prospective, multicenter, randomized, open-label controlled Phase 1b/2a study designed to evaluate the safety and preliminary efficacy of MPCs combined with MasterGraft Granules when compared to use of autologous bone graft in the posterolateral fusion site in subjects requiring interbody fusion in combination with instrumented 1 or 2 level PLF procedure. All subjects in this study will undergo a 1 or 2-level (2 or 3 vertebrae) interbody fusion without the use of the investigational product.
In addition to the interbody fusion procedure, subjects will undergo an instrumented posterolateral fusion. NeoFuse plus MasterGraft Granules at one of three doses or autograft will be implanted in the posterolateral lumbar fusion site(s) only.
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, and 12 months after surgery.
Subjects will be evaluated at 24 and 36 months after surgery for safety.
- Being tested
- PLF with autograft, PLF with NeoFuse
- Keywords
- Degenerative disc disease, Spondylolisthesis, Spinal stenosis, Stem cell, Spinal Fusion
- 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.
PLF with autograftProcedure or surgery
Also called spinal fusion
6 subjects
PLF with NeoFuseBiological
Also called spinal fusion, stem cell
6 subjects low dose
PLF with NeoFuseBiological
Also called spinal fusion, stem cell
6 subjects medium dose
PLF with NeoFuseBiological
Also called spinal fusion, stem cell
6 subjects high dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Autograft Receives: Procedure: PLF with autograft |
| 2 | Experimental | Low Dose MPCs Receives: Biological: PLF with NeoFuse |
| 3 | Experimental | Medium Dose MPCs Receives: Biological: PLF with NeoFuse |
| 4 | Experimental | High Dose MPCs Receives: Biological: PLF with NeoFuse |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety of NeoFuse (allogeneic mesenchymal precursor cells [MPCs] when combined with MasterGraft Resorbable Ceramic granules as a carrier for posterolateral lumbar fusion (PLF) with instrumentation
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 access the change in outcomes (ODI, SF-36) and pain (VAS)
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 posted18 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2011 (estimated)
- Study completionNov 2011 (estimated)
Why it stopped: Sponsor preferred a better study design
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to one of four (4) parallel treatment arms; autograft standard of care control, or one of three (3) doses of mesenchymal precursor cells (MPCs) combined with MasterGraft Granules. Subjects randomized to receive investigational product will be treated with one of the following three doses of allogeneic MPCs in 4 milliliters (mLs) per posterolateral lumbar fusion (PLF) level (204 mLs per side): 25 million (M), 50M or 75M MPCs per PLF level (or a total dose of 50 million, 100 million or 150 million MPCs if subject undergoes fusion at two levels). Each of the four treatment groups will include six (6) evaluable subjects.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mesoblast, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Donna Skerrett, MD, Principal investigator, Mesoblast, Ltd., c/o Angioblast Systems, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810212
- Sponsor's protocol ID
- MSB-SF002
- Status last verified
- Jun 2020
- First submitted
- 17 Dec 2008
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 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 Granules in Subjects Undergoing Posterolateral Lumbar Fusion With Instrumentation
- ClinicalTrials.gov ID
- NCT00810212
- Acronym / sponsor ID
- MSB-SF002
- Keywords
- Degenerative disc disease, Spondylolisthesis, Spinal stenosis, Stem cell, Spinal Fusion
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor preferred a better study design
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mesoblast, Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 18 Dec 2008 (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 safety and preliminary efficacy of Neofusetm in subjects with a diagnosis of degenerative disc disease (DDD) in 1 or 2 adjacent vertebral levels between L1 and S1 and undergoing posterolateral lumbar fusion.
Detailed description
This is a prospective, multicenter, randomized, open-label controlled Phase 1b/2a study designed to evaluate the safety and preliminary efficacy of MPCs combined with MasterGraft Granules when compared to use of autologous bone graft in the posterolateral fusion site in subjects requiring interbody fusion in combination with instrumented 1 or 2 level PLF procedure. All subjects in this study will undergo a 1 or 2-level (2 or 3 vertebrae) interbody fusion without the use of the investigational product.
In addition to the interbody fusion procedure, subjects will undergo an instrumented posterolateral fusion. NeoFuse plus MasterGraft Granules at one of three doses or autograft will be implanted in the posterolateral lumbar fusion site(s) only.
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, and 12 months after surgery.
Subjects will be evaluated at 24 and 36 months after surgery for safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Subjects will be randomized to one of four (4) parallel treatment arms; autograft standard of care control, or one of three (3) doses of mesenchymal precursor cells (MPCs) combined with MasterGraft Granules. Subjects randomized to receive investigational product will be treated with one of the following three doses of allogeneic MPCs in 4 milliliters (mLs) per posterolateral lumbar fusion (PLF) level (204 mLs per side): 25 million (M), 50M or 75M MPCs per PLF level (or a total dose of 50 million, 100 million or 150 million MPCs if subject undergoes fusion at two levels). Each of the four treatment groups will include six (6) evaluable subjects.
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: PLF with autograftAutograft |
| 2 | Experimental | Biological: PLF with NeoFuseLow Dose MPCs |
| 3 | Experimental | Biological: PLF with NeoFuseMedium Dose MPCs |
| 4 | Experimental | Biological: PLF with NeoFuseHigh Dose MPCs |
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 or applicable regulations outside 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 ≤ -3.5 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 |
|---|---|---|
| PLF with autograftAlso: spinal fusion6 subjects | Procedure or surgery | 1 |
| PLF with NeoFuseAlso: spinal fusion, stem cell6 subjects low dose | Biological | 2 |
| PLF with NeoFuseAlso: spinal fusion, stem cell6 subjects medium dose | Biological | 3 |
| PLF with NeoFuseAlso: spinal fusion, stem cell6 subjects high dose | Biological | 4 |
Primary outcome
To determine the safety of NeoFuse (allogeneic mesenchymal precursor cells [MPCs] when combined with MasterGraft Resorbable Ceramic granules as a carrier for posterolateral lumbar fusion (PLF) with instrumentation
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 access the change in outcomes (ODI, SF-36) and pain (VAS)
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
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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.
Donna Skerrett, MD principal investigator
Mesoblast, Ltd., c/o Angioblast Systems, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PLF with autograft and PLF with NeoFuse in people with Degenerative Disc Disease and Degenerative Spondylolisthesis, run by Mesoblast, Ltd. at 1 site 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: withdrawn, as of the sponsor's last update on 2 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 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was withdrawn before enrolling participants, so there are no results.
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 safety of NeoFuse (allogeneic mesenchymal precursor cells [MPCs] when combined with MasterGraft Resorbable Ceramic granules as a carrier for posterolateral lumbar fusion (PLF) with instrumentation (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 2 Jun 2020.