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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 is a Phase 2 study that has completed, run by Mesoblast. The registered enrollment target is 24 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01097486
The ClinicalTrials.gov registry entry for NCT01097486 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. The listed sponsor is Mesoblast, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which NeoFuse is the first listed.
NCT01097486 reports 0 study locations.
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.
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