Safety and Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy and Fusion
|Cervical Degenerative Disc Disease Degenerative Spondylolisthesis Spinal Stenosis||Procedure: NeoFuse Procedure: MasterGraft Granules||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase 2 Study Evaluating Safety and Preliminary Efficacy of NeoFuse When Combined With MasterGraft Matrix in Subjects Undergoing Multi-Level Anterior Cervical Discectomy and Fusion With Anterior Cervical Plate Fixation|
- Safety of NeoFuse [ Time Frame: 2 years ]To determine the safety of NeoFuse using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests (hematology, serum chemistry, inflammation, and and immunology).
- Fusion success with NeoFuse [ Time Frame: 1 year ]To evaluate the fusion success with NeoFuse compared to an active control using CT scans and x-ray of the involved cervical spine levels and assess the change in outcomes (NDI, SF-36, Zung Depression Questionnaire, and WPAI.
|Study Start Date:||June 2010|
|Study Completion Date:||March 2013|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Anterior Cervical Discectomy and Fusion with NeoFuse
Single Dose NeoFuse Surgical Implantation
Active Comparator: MasterGraft Granules
Anterior Cervical Discectomy and Fusion with MasterGraft Granules
Procedure: MasterGraft Granules
Single Dose MaterGraft Granules Surgical Implantation
This is a prospective, multicenter, randomized, single-blinded, controlled study evaluating safety and preliminary efficacy of immunoselected, culture-expanded, nucleated, allogeneic MPCs (NeoFuse) combined with MasterGraft Matrix in a commercially available PEEK cervical Spacer compared to an active control in subjects undergoing 2 or 3 level anterior cervical discectomy and fusion with anterior cervical plate fixation.
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, 12, and 24 months after surgery.
Subjects will be evaluated at the same time points for safety.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01106417
|Monash Medical Centre|
|Clayton, Victoria, Australia, 3168|
|Royal Melbourne Hospital|
|Melbourne, Victoria, Australia, 3050|
|Study Director:||Roger Brown||Mesoblast, Ltd.|