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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01106417
Study type Interventional
Source Mesoblast, Ltd.
Contact
Status Completed
Phase Phase 1/Phase 2
Start date June 2010
Completion date March 2013

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