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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.

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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

FieldValue
Enrollment Target 24 participants
Start Date 2010-06
Est. Completion 2014-07
Phase Phase 2

Sponsor

Mesoblast

25 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.