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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
24
UC Davis Spine Center
Sacramento, California, United States
The Spine Institute
Santa Monica, California, United States
Denver Spine
Denver, Colorado, United States
Rocky Mountain Associates in Orthopedic Medicine, P.C.
Loveland, Colorado, United States
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).
Time frame: 2 years
To evaluate the fusion success with NeoFuse compared to allograft spacer 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.
Time frame: 1 years
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Tallahassee Neurological Clinic, P.A.
Tallahassee, Florida, United States
Fort Wayne Orthopaedics
Fort Wayne, Indiana, United States
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, United States
Central Texas Spine Institute
Austin, Texas, United States