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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: Completed Phase 1 study, sponsored by Mesoblast.
NCT00549913 is a Phase 1 study that has completed, run by Mesoblast. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00549913 record still lists
NCT00549913 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which NeoFuse is the first listed.
NCT00549913 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00549913's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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