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Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion

NCT00996073 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

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) in 1 or 2 adjacent vertebral levels between L1 and S1. All subjects in this study will undergo interbody fusion via Transforaminal Lumbar Interbody Fusion (TLIF) or Posterior Lumbar Interbody Fusion (PLIF) procedures with Food and Drug Administration (FDA) approved/cleared supplemental posterior instrumentation.

Conditions

  • Degenerative Disc Disease
  • Degenerative Spondylolisthesis
  • Spinal Stenosis

Interventions

BIOLOGICAL

Lumbar Interbody Fusion with Autograft

Single Dose Autograft Surgical Implantation

BIOLOGICAL

Lumbar Interbody Fusion with NeoFuse

Single Dose NeoFuse Surgical Implantation

BIOLOGICAL

Lumbar Interbody Fusion with NeoFuse

Single Dose NeoFuse Surgical Implantation

Sponsors & Collaborators

  • Mesoblast, Ltd.

    lead INDUSTRY

Principal Investigators

  • Roger Brown · Senior Vice President of Musculoskeletal Repair

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
2009-09-30
Primary Completion
2012-07-31
Completion
2014-07-31

Countries

  • United States

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 NCT00996073 on ClinicalTrials.gov