Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion

Status:	Archived
Conditions:	Orthopedic
Therapuetic Areas:	Orthopedics / Podiatry
Healthy:	No
Age Range:	Any
Updated:	7/1/2011
Start Date:	September 2009
End Date:	March 2013

A Prospective, Multicenter, Randomized, Open-Label, Controlled Study Evaluating Safety and Preliminary Efficacy of NeoFuse When Combined With MasterGraft Matrix in Subjects Undergoing Lumbar Interbody Fusion With Instrumentation

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) in 1 or 2 adjacent vertebral
levels between L1 and S1. All subjects in this study will undergo interbody fusion via
Transforaminal Lumbar Interbody Fusion (TLIF) or Posterior Lumbar Interbody Fusion (PLIF)
procedures with Food and Drug Administration (FDA) approved/cleared supplemental posterior
instrumentation.

This is a prospective, multicenter, randomized, open-label controlled Phase 2 study designed
to evaluate the safety and preliminary efficacy of adult, allogeneic mesenchymal precursor
cells (MPCs) combined with MasterGraft Matrix when compared to use of autologous iliac crest
bone graft in the lumbar interbody fusion site in subjects requiring 1 or 2 level interbody
fusion procedure with instrumentation. All subjects in this study will undergo a 1 or
2-level (2 or 3 vertebrae) interbody fusion with supplemental posterior instrumentation.

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, 12, 24, and 36
months after surgery.

Subjects will be evaluated at the same time points for safety.

We found this trial at

sites

Central Texas Spine Institute

Austin, Texas 78731

from

Austin, TX