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

NCT01106417 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-06-29

No results posted yet for this study

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.

Conditions

  • Cervical Degenerative Disc Disease
  • Degenerative Spondylolisthesis
  • Spinal Stenosis

Interventions

BIOLOGICAL

NeoFuse

Single Dose NeoFuse Surgical Implantation

DEVICE

MasterGraft Granules

Single Dose MaterGraft Granules Surgical Implantation

Sponsors & Collaborators

  • Mesoblast, Ltd.

    lead INDUSTRY

Principal Investigators

  • Roger Brown · Mesoblast, Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-05-31
Completion
2013-03-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01106417 on ClinicalTrials.gov