NCT00996073

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Mesoblast, Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Degenerative Disc Disease
• Degenerative Spondylolisthesis
• Spinal Stenosis

Interventions

Type	Name	Description
BIOLOGICAL	Lumbar Interbody Fusion with Autograft	Single Dose Autograft Surgical Implantation
BIOLOGICAL	Lumbar Interbody Fusion with NeoFuse	Single Dose NeoFuse Surgical Implantation
BIOLOGICAL	Lumbar Interbody Fusion with NeoFuse	Single Dose NeoFuse Surgical Implantation

Timeline

• Start date: 2009-09-01
• Primary completion: 2012-07-01
• Completion: 2014-07-01
• First posted: 2009-10-16
• Last updated: 2020-06-29

Locations

5 sites across 1 country: United States