Safety and Preliminary Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy

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 a cervical Allograft Spacer 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.

Inclusion criteria

• 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) [per Health Insurance Portability and Accountability Act (HIPAA) privacy ruling in the US].
• 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.

Exclusion criteria

• 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.