Degenerative Disc DiseasePhase 1/2NCT00549913
Study of 3 Doses of NeoFuse Combined With MasterGraft Granules in Subjects Requiring Posterolateral Lumbar Fusion (PLF)
A Phase 1/2 study testing NeoFuse and posterolateral spinal fusion with instrumentation in people with Degenerative Disc Disease and Spondylolisthesis, run by Mesoblast, Ltd. at 1 site in United States.
Trial summary
This is a first-in-human, dose escalation clinical study to evaluate the feasibility, safety, and tolerability of 3 different doses of immunoselected, culture-expanded, nucleated, allogeneic MPCs (NeoFuse) when combined with MasterGraft Resorbable Ceramic Granules (Medtronic Sofamor Danek USA, Inc.) compared to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease, Spondylolisthesis, Spinal Stenosis
- What is being tested?
- NeoFuse and posterolateral spinal fusion with instrumentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Sep 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ≥ 18 years of age.
- 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.
- May also have coexistent spinal or foraminal stenosis as confirmed by MRI or CT evaluation.
- Must have clinical symptoms of neurogenic claudication.
- Must have failed 6 months of nonoperative management.
- Must be a candidate for lumbar interbody fusion in combination with posterolateral lumbar fusion with the use of autograft from the iliac crest requiring a 1 or 2-level fusion of adjacent vertebral levels between L1 and S1.
- Must have a stable screening electrocardiogram (ECG), as determined by the investigator that would not preclude surgery.
Who cannot join
- Is pregnant or breastfeeding.
- Has Grade III or greater spondylolisthesis.
- Has or is undergoing revision of a prior fusion at the involved levels.
- Has a history of hypersensitivity or anaphylactic reaction to murine or bovine products, dimethyl sulfoxide (DMSO), or titanium.
- Has MRI or CT that shows greater than 50% anterior translocation of cranial vertebral body or greater than 20 degree angular motion of the listhesis segment.
- Has a history of active malignancy in the last 5 years, other than basal cell carcinoma.
Show all 17Show fewer
- Has osteoporosis as defined by a dual energy x-ray absorptiometry (DXA T) score of ≤ -3.5 or a history of fragility fractures or other significant bone disease contraindicating the use of spinal instrumentation.
- Note: subjects will be screened using the Simple Calculated Osteoporosis Risk Evaluation (SCORE) osteoporosis questionnaire.
- Has a history of Paget's disease of the spine, osteomalacia, or any other metabolic bone disease.
- Has a history of prior radiotherapy to the involved area.
- Has received systemic corticosteroids at a dose equivalent to prednisone > 10 mg/day within 14 days prior to study procedure.
- Has received systemic nonsteroidal anti-inflammatory drugs (NSAIDS) within 48 hours prior to study procedure, and unwilling to refrain from NSAIDS for the first 6 months following the procedure.
- Has a positive screen for human immunodeficiency virus (HIV) antibodies.
- Has had treatment with any investigational therapy administered within 6 months before implantation surgery. .
- Is the prior recipient of allogeneic stem cell/progenitor cell therapy.
- Has a body mass index (BMI) > 3.5
- Has 20% or greater anti-human leukocyte antigen (HLA) antibody titer and/or has antibody specificities to donor HLA antigens.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: A Dose-escalation Study to Assess the Feasibility and Safety of 3 Different Doses of NeoFuse When Combined With MasterGraft Granules in Subjects Requiring Posterolateral Lumbar Fusion With Instrumentation.
This is a first-in-human, dose escalation clinical study to evaluate the feasibility, safety, and tolerability of 3 different doses of immunoselected, culture-expanded, nucleated, allogeneic MPCs (NeoFuse) when combined with MasterGraft Resorbable Ceramic Granules (Medtronic Sofamor Danek USA, Inc.) compared to autograft in patients requiring posterior lumbar interbody fusion with NuVasive's radiolucent PEEK OPTIMA cage (to be used with autologous bone graft material) and 1 or 2 level posterolateral lumbar fusion surgery with instrumentation. The instrumentation used for this study will be the Monarch® 5.50 mm Spine System (DePuy).
Read the detailed description
This is a prospective, single center, 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, and 12 months after surgery.
Subjects will be evaluated at 24 and 36 months after surgery for safety.
- Being tested
- NeoFuse, posterolateral spinal fusion with instrumentation
- Keywords
- adjacent vertebral levels between L1 and S1
- Medical subject headings
- Intervertebral Disc Degeneration, Spondylolisthesis, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeoFuseBiological
Also called Spinal Fusion, Stem Cells
immunoselected, culture-expanded, nucleated, allogeneic MPCs (NeoFuse) combined with MasterGraft Resorbable Ceramic Granules in subjects requiring posterior lumbar interbody fusion with NuVasive's radiolucent PEEK OPTIMA cage
posterolateral spinal fusion with instrumentationProcedure or surgery
Also called Spinal Fusion, Controls
autograft in subjects requiring posterior lumbar interbody fusion with NuVasive's radiolucent PEEK OPTIMA cage
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 10 subjects to receive lowest dose of NeoFuse (MPCs) Receives: Biological: NeoFuse |
| 2 | Active comparator | 4 subjects standard posterolateral spinal fusion with instrumentation Receives: Procedure: posterolateral spinal fusion with instrumentation |
| 3 | Experimental | 10 subjects to receive middle dose of NeoFuse Receives: Biological: NeoFuse |
| 4 | Active comparator | 3 subjects standard posterolateral spinal fusion with instrumentation Receives: Procedure: posterolateral spinal fusion with instrumentation |
| 5 | Experimental | 10 subjects to receive highest dose of NeoFuse Receives: Biological: NeoFuse |
| 6 | Active comparator | 3 subjects with standard posterolateral spinal fusion with instrumentation Receives: Procedure: posterolateral spinal fusion with instrumentation |
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 with instrumentation.
Measured: 30 days
Secondary outcomes (3)
To evaluate the overall fusion success of the use of NeoFuse plus carrier compared to autograft in the same patient
Measured: 3 years
To assess CT scan as a pilot measure of fusion for use in the pivotal study
Measured: 3 years
To provide preliminary data to support dose selection
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 posted26 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionAug 2013
- Study completionSep 2013
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
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mesoblast, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Donna Skerrett, MD, Study director, Mesoblast, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00549913
- Sponsor's protocol ID
- MSF0106
- Status last verified
- Jun 2020
- First submitted
- 24 Oct 2007
- 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 Dose-escalation Study to Assess the Feasibility and Safety of 3 Different Doses of NeoFuse When Combined With MasterGraft Granules in Subjects Requiring Posterolateral Lumbar Fusion With Instrumentation.
- ClinicalTrials.gov ID
- NCT00549913
- Acronym / sponsor ID
- MSF0106
- Keywords
- adjacent vertebral levels between L1 and S1
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Mesoblast, Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 26 Oct 2007 (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.
This is a first-in-human, dose escalation clinical study to evaluate the feasibility, safety, and tolerability of 3 different doses of immunoselected, culture-expanded, nucleated, allogeneic MPCs (NeoFuse) when combined with MasterGraft Resorbable Ceramic Granules (Medtronic Sofamor Danek USA, Inc.) compared to autograft in patients requiring posterior lumbar interbody fusion with NuVasive's radiolucent PEEK OPTIMA cage (to be used with autologous bone graft material) and 1 or 2 level posterolateral lumbar fusion surgery with instrumentation. The instrumentation used for this study will be the Monarch® 5.50 mm Spine System (DePuy).
Detailed description
This is a prospective, single center, 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, 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
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: NeoFuse10 subjects to receive lowest dose of NeoFuse (MPCs) |
| 2 | Active comparator | Procedure: posterolateral spinal fusion with instrumentation4 subjects standard posterolateral spinal fusion with instrumentation |
| 3 | Experimental | Biological: NeoFuse10 subjects to receive middle dose of NeoFuse |
| 4 | Active comparator | Procedure: posterolateral spinal fusion with instrumentation3 subjects standard posterolateral spinal fusion with instrumentation |
| 5 | Experimental | Biological: NeoFuse10 subjects to receive highest dose of NeoFuse |
| 6 | Active comparator | Procedure: posterolateral spinal fusion with instrumentation3 subjects with standard posterolateral spinal fusion with instrumentation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women ≥ 18 years of age.
- 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.
- May also have coexistent spinal or foraminal stenosis as confirmed by MRI or CT evaluation.
- Must have clinical symptoms of neurogenic claudication.
- Must have failed 6 months of nonoperative management.
Key exclusion criteria (17 listed)
- Is pregnant or breastfeeding.
- Has Grade III or greater spondylolisthesis.
- Has or is undergoing revision of a prior fusion at the involved levels.
- Has a history of hypersensitivity or anaphylactic reaction to murine or bovine products, dimethyl sulfoxide (DMSO), or titanium.
- Has MRI or CT that shows greater than 50% anterior translocation of cranial vertebral body or greater than 20 degree angular motion of the listhesis segment.
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 |
|---|---|---|
| NeoFuseAlso: Spinal Fusion, Stem Cellsimmunoselected, culture-expanded, nucleated, allogeneic MPCs (NeoFuse) combined with MasterGraft Resorbable Ceramic Granules in subjects requiring posterior lumbar interbody fusion with NuVasive's radiolucent PEEK OPTIMA cage | Biological | 1, 3, 5 |
| posterolateral spinal fusion with instrumentationAlso: Spinal Fusion, Controlsautograft in subjects requiring posterior lumbar interbody fusion with NuVasive's radiolucent PEEK OPTIMA cage | Procedure or surgery | 2, 4, 6 |
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 with instrumentation.
Time frame: 30 days
3 secondary outcomes
To evaluate the overall fusion success of the use of NeoFuse plus carrier compared to autograft in the same patient
Time frame: 3 years
To assess CT scan as a pilot measure of fusion for use in the pivotal study
Time frame: 3 years
To provide preliminary data to support dose selection
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.
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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 study director
Mesoblast, Ltd.
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 NeoFuse and posterolateral spinal fusion with instrumentation in people with Degenerative Disc Disease and 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 7 inclusion and 17 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 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 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 safety of NeoFuse (allogeneic mesenchymal precursor cells [MPCs]) when combined with MasterGraft Resorbable Ceramic Granules as a carrier for posterolateral lumbar fusion with instrumentation. (time frame: 30 days). 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.