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Study of 3 Doses of NeoFuse Combined With MasterGraft Granules in Subjects Requiring Posterolateral Lumbar Fusion (PLF)

NCT00549913 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-06-29

No results posted yet for this study

Summary

This is a first-in-human, dose escalation clinical study to evaluate the feasibility, safety, and tolerability of 3 different doses of immunoselected, culture-expanded, nucleated, allogeneic MPCs (NeoFuse) when combined with MasterGraft Resorbable Ceramic Granules (Medtronic Sofamor Danek USA, Inc.) compared to autograft in patients requiring posterior lumbar interbody fusion with NuVasive's radiolucent PEEK OPTIMA cage (to be used with autologous bone graft material) and 1 or 2 level posterolateral lumbar fusion surgery with instrumentation. The instrumentation used for this study will be the Monarch® 5.50 mm Spine System (DePuy).

Conditions

  • Degenerative Disc Disease
  • Spondylolisthesis
  • Spinal Stenosis

Interventions

BIOLOGICAL

NeoFuse

immunoselected, culture-expanded, nucleated, allogeneic MPCs (NeoFuse) combined with MasterGraft Resorbable Ceramic Granules in subjects requiring posterior lumbar interbody fusion with NuVasive's radiolucent PEEK OPTIMA cage

PROCEDURE

posterolateral spinal fusion with instrumentation

autograft in subjects requiring posterior lumbar interbody fusion with NuVasive's radiolucent PEEK OPTIMA cage

Sponsors & Collaborators

  • Mesoblast, Ltd.

    lead INDUSTRY

Principal Investigators

  • Donna Skerrett, MD · Mesoblast, Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2013-08-31
Completion
2013-09-30

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 NCT00549913 on ClinicalTrials.gov