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Sponsored by: |
Mesoblast, Ltd. |
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Information provided by: | Mesoblast, Ltd. |
ClinicalTrials.gov Identifier: | NCT00810212 |
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.
Condition | Intervention | Phase |
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Degenerative Disc Disease Degenerative Spondylolisthesis Spinal Stenosis |
Procedure: PLF with autograft Genetic: PLF with NeoFuse |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety 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 |
Estimated Enrollment: | 24 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | November 2011 |
Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Autograft
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Procedure: PLF with autograft
6 subjects
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2: Experimental
Low Dose
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Genetic: PLF with NeoFuse
6 subjects low dose
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3: Experimental
Medium Dose
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Genetic: PLF with NeoFuse
6 subjects medium dose
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4: Experimental
High Dose
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Genetic: PLF with NeoFuse
6 subjects high dose
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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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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.
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United States, Texas | |
Texas Back Institute | Recruiting |
Plano, Texas, United States, 75093 | |
Contact: Vickie Arford, RN varford@spinemarkcro.com | |
Principal Investigator: Richard Guyer, MD |
Principal Investigator: | Donna Skerrett, MD | Mesoblast, Ltd., c/o Angioblast Systems, Inc. |
Responsible Party: | Mesoblast, Ltd., c/o Angioblast Systems, inc. ( Donna Skerrett, MD, Medical Officer ) |
Study ID Numbers: | MSB-SF002 |
Study First Received: | December 17, 2008 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00810212 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Degenerative disc disease Spondylolisthesis Spinal stenosis Stem cell Spinal Fusion |
Spinal Diseases Musculoskeletal Diseases Constriction, Pathologic |
Spondylolisthesis Bone Diseases Spinal Stenosis |
Spinal Diseases Musculoskeletal Diseases Spondylolisthesis Bone Diseases Spinal Stenosis |