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Sponsored by: |
Mesoblast, Ltd. |
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Information provided by: | Mesoblast, Ltd. |
ClinicalTrials.gov Identifier: | NCT00549913 |
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 |
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Degenerative Disc Disease Spondylolisthesis Spinal Stenosis |
Genetic: NeoFuse Procedure: posterolateral spinal fusion with instrumentation |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety 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. |
Estimated Enrollment: | 40 |
Study Start Date: | October 2007 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
10 subjects to receive lowest dose of NeoFuse
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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
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2: Active Comparator
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
|
3: Experimental
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
|
4: Active Comparator
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
|
5: Experimental
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
|
6: Active Comparator
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
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Must meet the following laboratory 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.
Contact: Donna Skerrett, MD | 1-888-369-2123 | donna.skerrett@mesoblast.com |
United States, Massachusetts | |
Hospital for Special Surgery | Recruiting |
New York, Massachusetts, United States, 10021 | |
Contact: Andrew A Sama, MD 212-606-1122 samaa@hss.edu | |
Contact: Padhraig O'Loughlin, MD 212-606-1172 poloughlinp@hss.edu |
Study Director: | Donna Skerrett, MD | Mesoblast, Ltd. |
Responsible Party: | Mesoblast, Ltd., c/o Angioblast Systems, Inc. ( Donna Skerrett, MD ; Medical Director ) |
Study ID Numbers: | MSF0106 |
Study First Received: | October 24, 2007 |
Last Updated: | February 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00549913 History of Changes |
Health Authority: | United States: Food and Drug Administration |
adjacent vertebral levels between L1 and S1 |
Spinal Diseases Musculoskeletal Diseases Constriction, Pathologic |
Spondylolisthesis Bone Diseases Spinal Stenosis |
Spinal Diseases Musculoskeletal Diseases Spondylolisthesis Bone Diseases Spinal Stenosis |