Degenerative Disc Disease Clinical Trial
Official title:
A Prospective, Multicenter, Randomized, Open-Label, Controlled Study Evaluating Safety and Preliminary Efficacy of NeoFuse When Combined With Mastergraft Granules in Subjects Undergoing Posterolateral Lumbar Fusion With Instrumentation
The purpose of this study is to evaluate safety and preliminary efficacy of Neofusetm in subjects with a diagnosis of degenerative disc disease (DDD) in 1 or 2 adjacent vertebral levels between L1 and S1 and undergoing posterolateral lumbar fusion.
This is a prospective, multicenter, randomized, open-label controlled Phase 1b/2a study
designed to evaluate the safety and preliminary efficacy of MPCs combined with MasterGraft
Granules when compared to use of autologous bone graft in the posterolateral fusion site in
subjects requiring interbody fusion in combination with instrumented 1 or 2 level PLF
procedure. All subjects in this study will undergo a 1 or 2-level (2 or 3 vertebrae)
interbody fusion without the use of the investigational product.
In addition to the interbody fusion procedure, subjects will undergo an instrumented
posterolateral fusion. NeoFuse plus MasterGraft Granules at one of three doses or autograft
will be implanted in the posterolateral lumbar fusion site(s) only.
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, 9, and 12 months after
surgery.
Subjects will be evaluated at 24 and 36 months after surgery for safety.
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