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NCT00549913 · ClinicalTrials.gov registry record · Phase 1
Study of 3 Doses of NeoFuse Combined With MasterGraft Granules in Subjects Requiring Posterolateral Lumbar Fusion (PLF)
A Phase 1 study, sponsored by Mesoblast.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT00549913 is a Phase 1 study that has completed, run by Mesoblast. The registered enrollment target is 6 participants.
The verdict
NCT00549913, a Phase 1 study, has completed, sponsored by Mesoblast.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
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).
Interventions
- BIOLOGICAL NeoFuse
- PROCEDURE posterolateral spinal fusion with instrumentation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2007-10 |
| Est. Completion | 2013-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00549913
The ClinicalTrials.gov registry entry for NCT00549913 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 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.
NCT00549913 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00549913 about?
NCT00549913 is a clinical study titled "Study of 3 Doses of NeoFuse Combined With MasterGraft Granules in Subjects Requiring Posterolateral Lumbar Fusion (PLF)". 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.)...
What is the current status of trial NCT00549913?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2007-10. Estimated completion is 2013-09.
What interventions are being tested in trial NCT00549913?
The interventions under investigation include: NeoFuse (BIOLOGICAL), posterolateral spinal fusion with instrumentation (PROCEDURE).
Who is sponsoring clinical trial NCT00549913?
This trial is sponsored by Mesoblast, which has 25 total clinical trials registered on ClinicalTrials.gov.
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