NCT00810212

Safety and Efficacy Study of NeoFuse in Subjects Requiring Posterolateral Lumbar Fusion

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

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (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 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.

Detailed description

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.

Conditions

• Degenerative Disc Disease
• Degenerative Spondylolisthesis
• Spinal Stenosis

Interventions

Type	Name	Description
PROCEDURE	PLF with autograft	6 subjects
BIOLOGICAL	PLF with NeoFuse	6 subjects low dose
BIOLOGICAL	PLF with NeoFuse	6 subjects medium dose
BIOLOGICAL	PLF with NeoFuse	6 subjects high dose

Timeline

• Start date: 2008-11-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2008-12-18
• Last updated: 2020-06-02

Locations

1 site across 1 country: United States