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Safety and Efficacy Study of NeoFuse in Subjects Requiring Posterolateral Lumbar Fusion

NCT00810212 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2020-06-02

No results posted yet for this study

Summary

The purpose of this study is to evaluate safety and preliminary efficacy of Neofusetm in subjects with a diagnosis of degenerative disc disease (DDD) in 1 or 2 adjacent vertebral levels between L1 and S1 and undergoing posterolateral lumbar fusion.

Conditions

  • Degenerative Disc Disease
  • Degenerative Spondylolisthesis
  • Spinal Stenosis

Interventions

PROCEDURE

PLF with autograft

6 subjects

BIOLOGICAL

PLF with NeoFuse

6 subjects low dose

BIOLOGICAL

PLF with NeoFuse

6 subjects medium dose

BIOLOGICAL

PLF with NeoFuse

6 subjects high dose

Sponsors & Collaborators

  • Mesoblast, Ltd.

    lead INDUSTRY

Principal Investigators

  • Donna Skerrett, MD · Mesoblast, Ltd., c/o Angioblast Systems, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2011-11-30
Completion
2011-11-30

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 NCT00810212 on ClinicalTrials.gov