Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00996073 · ClinicalTrials.gov registry record · Phase 2
Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion
A Phase 2 study of Degenerative Disc Disease and Spinal Stenosis, sponsored by Mesoblast.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 5
- Study locations
NCT00996073 is a Phase 2 study of Degenerative Disc Disease and Spinal Stenosis that has completed, run by Mesoblast. The registered enrollment target is 24 participants, below the 168-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (86% lower). The trial reports 5 study locations across 4 states.
The verdict
NCT00996073, a Phase 2 study of Degenerative Disc Disease and Spinal Stenosis, has completed, sponsored by Mesoblast.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 5
- Study locations
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 Studied
Interventions
- BIOLOGICAL Lumbar Interbody Fusion with Autograft
- BIOLOGICAL Lumbar Interbody Fusion with NeoFuse
Study Locations (5)
Colorado
- Denver Spine - Greenwood Village
- Rocky Mountain Associates in Orthopedic Medicine, P.C. - Loveland
California
- The Spine Institute - Santa Monica
Indiana
- Fort Wayne Orthopaedics - Fort Wayne
Texas
- Central Texas Spine Institute - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2009-09 |
| Est. Completion | 2014-07 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00996073
The ClinicalTrials.gov registry entry for NCT00996073 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 168-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (86% lower). The listed sponsor is Mesoblast, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Degenerative Disc Disease appearing as the primary indexed condition, and to 2 interventions - of which Lumbar Interbody Fusion with Autograft is the first listed.
NCT00996073 reports 5 study locations spanning 4 distinct geographic areas - top geographies include Colorado, California, Indiana.
Frequently Asked Questions
What is clinical trial NCT00996073 about?
NCT00996073 is a clinical study titled "Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion". 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 ...
What is the current status of trial NCT00996073?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2009-09. Estimated completion is 2014-07.
What conditions does trial NCT00996073 study?
This clinical trial studies the following conditions: Degenerative Disc Disease, Spinal Stenosis, Degenerative Spondylolisthesis.
What interventions are being tested in trial NCT00996073?
The interventions under investigation include: Lumbar Interbody Fusion with Autograft (BIOLOGICAL), Lumbar Interbody Fusion with NeoFuse (BIOLOGICAL).
Who is sponsoring clinical trial NCT00996073?
This trial is sponsored by Mesoblast, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00996073 being conducted?
This trial has 5 study locations across California, Colorado, Indiana, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Degenerative Disc Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
OssDsign® Spine Registry Study ("Propel")
RECRUITING
-
A Study to Evaluate the Effectiveness of IDCT (Intradiscal Cell Therapy) in Subjects With One Level, Symptomatic Mild to Moderate Lumbar Degenerative Disc Disease
RECRUITING · Phase 3
-
LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)
RECRUITING · Phase 1
-
Investigation of DEXA-C Anterior Cervical Interbody System
RECRUITING · NA
-
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
RECRUITING · NA
-
Trial for Treating Painful Degenerative Disc Disease
RECRUITING · NA
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.