NCT01106417

Safety and Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy and Fusion

Phase 2 Study Evaluating Safety and Preliminary Efficacy of NeoFuse When Combined With MasterGraft Matrix in Subjects Undergoing Multi-Level Anterior Cervical Discectomy and Fusion With Anterior Cervical Plate Fixation

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (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) 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.

Detailed description

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 an active 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.

Conditions

• Cervical Degenerative Disc Disease
• Degenerative Spondylolisthesis
• Spinal Stenosis

Interventions

Type	Name	Description
BIOLOGICAL	NeoFuse	Single Dose NeoFuse Surgical Implantation
DEVICE	MasterGraft Granules	Single Dose MaterGraft Granules Surgical Implantation

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-05-01
• Completion: 2013-03-01
• First posted: 2010-04-19
• Last updated: 2020-06-29

Locations

2 sites across 1 country: Australia