Safety and Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy and Fusion
|ClinicalTrials.gov Identifier: NCT01106417|
Recruitment Status : Completed
First Posted : April 19, 2010
Last Update Posted : December 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cervical Degenerative Disc Disease Degenerative Spondylolisthesis Spinal Stenosis||Procedure: NeoFuse Procedure: MasterGraft Granules||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||June 2010|
|Primary Completion Date :||May 2012|
|Study Completion Date :||March 2013|
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01106417
|Monash Medical Centre|
|Clayton, Victoria, Australia, 3168|
|Royal Melbourne Hospital|
|Melbourne, Victoria, Australia, 3050|
|Study Director:||Roger Brown||Mesoblast, Ltd.|