Safety and Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy and Fusion
This trial has been completed.
|Conditions||cervical degenerative disc disease, degenerative spondylolisthesis, spinal stenosis|
|Treatments||neofuse, mastergraft granules|
|Start date||June 2010|
|End date||May 2012|
|Trial size||12 participants|
|Trial identifier||NCT01106417, MSB-CF001|
The purpose of this study is to evaluate the safety and preliminary efficacy of NeoFuse in subjects with a diagnosis of degenerative disc disease (DDD) at 2 or more adjacent cervical vertebral levels between C3-C4 to C7-T1. All subjects in this study will undergo 2 or 3 level anterior cervical discectomy and fusion with Anterior Cervical Plate Fixation.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
Safety of NeoFuse
time frame: 2 years
Fusion success with NeoFuse
time frame: 1 year
Male or female participants from 18 years up to 70 years old.
- Male or females between 18 and 70 years of age, inclusive.
- Has the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol.
- Has the ability to understand and provide written authorization for the use and disclosure of personal health information (PHI).
- Has a documented symptomatic diagnosis of DDD at C3-C4 to C7-T1.
- Has symptomatic radiculopathy and/or myelopathy correlating to radiographic findings of duration of 6 weeks or greater that had failed to respond to non-operative management
- Is a candidate for anterior cervical discectomy and fusion in two or three adjacent cervical interbody levels between C3-C4 to C7-T1
- Has a stable screening electrocardiogram (ECG), as determined by the investigator that would not preclude surgery.
- Female subjects who are pregnant or nursing, or women planning to become pregnant during the first year (12 months) following surgery.
- Has a current or prior history within the last 3 years of neoplasm (excluding basal cell carcinoma) and/or any active neoplasm within the last 24 months, prior to screening.
- Has at the time of surgery a systemic or local infection at the site of proposed surgery.
- Has or is undergoing revision of a prior fusion surgery at any involved level.
- Requires ACDF at only one cervical interbody level or more than 3 adjacent cervical interbody levels.
- Requires ACDF without the use of an anterior cervical plating system.
- Has osteoporosis as defined by a DEXA T score of ≤ -3.0 or a history of fragility fractures or other significant bone disease contraindicating the use of spinal instrumentation.
- Has a documented medical history or radiographic evidence of a metabolic bone disease or other condition which would negatively impact the bone healing process.
- Has a positive screen for human immunodeficiency virus (HIV) antibodies.
- Has had treatment with any investigational therapy or device within 6 months of study surgery and/or plans to participate in any other allogeneic stem cell/progenitor cell therapy trial during the 2-year follow-up period.
- Has been a recipient of prior stem cell/progenitor cell therapy for spinal fusion surgery.
- Has 20% or greater anti-human leukocyte antigen (HLA) antibody titer and/or has antibody specificities to donor HLA antigens.
- Is transient or has been treated in the last 6 months before enrollment for alcohol and/or drug abuse in an inpatient substance abuse program.
|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|
|Description||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.|
Call for more information