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NCT01097486 · ClinicalTrials.gov registry record · Phase 2
Safety and Preliminary Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy
A Phase 2 study, sponsored by Mesoblast.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT01097486: Completed Phase 2 study, sponsored by Mesoblast.
NCT01097486 is a Phase 2 study that has completed, run by Mesoblast. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01097486, a Phase 2 study, has completed, sponsored by Mesoblast.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
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.
Interventions
- BIOLOGICAL NeoFuse
- PROCEDURE Allograft
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2010-06 |
| Est. Completion | 2014-07 |
| Phase | Phase 2 |
What the finished NCT01097486 record still lists
NCT01097486 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which NeoFuse is the first listed.
NCT01097486 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01097486 about?
NCT01097486 is a clinical study titled "Safety and Preliminary Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy". 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 disce...
What is the current status of trial NCT01097486?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2010-06. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01097486?
The interventions under investigation include: NeoFuse (BIOLOGICAL), Allograft (PROCEDURE).
Who is sponsoring clinical trial NCT01097486?
This trial is sponsored by Mesoblast, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01097486's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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