drugset / Trial / NCT01106417

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

NCT01106417

Phase 1/2 Completed 12 enrolled Mesoblast, Inc.
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2010-06
Primary completion
2012-05
Completion
2013-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Rexlemestrocel-L Cell therapy