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| Sponsor: | Mesoblast, Ltd. |
|---|---|
| Information provided by (Responsible Party): | Mesoblast, Ltd. |
| ClinicalTrials.gov Identifier: | NCT00549913 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Degenerative Disc Disease Spondylolisthesis Spinal Stenosis |
Genetic: NeoFuse Procedure: posterolateral spinal fusion with instrumentation |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
| Estimated Enrollment: | 40 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
10 subjects to receive lowest dose of NeoFuse
|
Genetic: NeoFuse
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
Other Names:
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Active Comparator: 2
4 subjects standard posterolateral spinal fusion with instrumentation
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Procedure: posterolateral spinal fusion with instrumentation
autograft in subjects requiring posterior lumbar interbody fusion with NuVasive's radiolucent PEEK OPTIMA cage
Other Names:
|
|
Experimental: 3
10 subjects to receive middle dose of NeoFuse
|
Genetic: NeoFuse
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
Other Names:
|
|
Active Comparator: 4
3 subjects standard posterolateral spinal fusion with instrumentation
|
Procedure: posterolateral spinal fusion with instrumentation
autograft in subjects requiring posterior lumbar interbody fusion with NuVasive's radiolucent PEEK OPTIMA cage
Other Names:
|
|
Experimental: 5
10 subjects to receive highest dose of NeoFuse
|
Genetic: NeoFuse
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
Other Names:
|
|
Active Comparator: 6
3 subjects with standard posterolateral spinal fusion with instrumentation
|
Procedure: posterolateral spinal fusion with instrumentation
autograft in subjects requiring posterior lumbar interbody fusion with NuVasive's radiolucent PEEK OPTIMA cage
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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.
Contacts and Locations
More Information
| Responsible Party: | Mesoblast, Ltd. |
| ClinicalTrials.gov Identifier: | NCT00549913 History of Changes |
| Other Study ID Numbers: | MSF0106 |
| Study First Received: | October 24, 2007 |
| Last Updated: | August 19, 2011 |
| Health Authority: | United States: Food and Drug Administration |
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adjacent vertebral levels between L1 and S1 |
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Spinal Stenosis Spondylolisthesis Intervertebral Disk Degeneration Spinal Diseases |
Bone Diseases Musculoskeletal Diseases Spondylolysis Spondylosis |