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NCT00366145 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Adult Human Mesenchymal Stem Cells to Treat Steroid Refractory Acute Graft Versus Host Disease (GVHD)
A Phase 3 study, sponsored by Mesoblast.
- Completed
- Registry status
- Phase 3
- Development phase
- 260
- Enrollment target
NCT00366145: Completed Phase 3 study, sponsored by Mesoblast.
NCT00366145 is a Phase 3 study that has completed, run by Mesoblast. The registered enrollment target is 260 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00366145, a Phase 3 study, has completed, sponsored by Mesoblast.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 260 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and gather additional safety information for Prochymal® in participants who have failed to respond to steroid treatment of Grades B-D acute GVHD.
Primary Outcome
A complete response was defined as complete resolution of all clinical signs of Graft versus host disease (GVHD)- that had to be maintained for at least 28 consecutive days (durable complete response \[DCR\]) within 100 days post first infusion.
Interventions
- DRUG Placebo
- BIOLOGICAL Prochymal®
- DRUG Standard of Care for GVHD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2006-08-17 |
| Est. Completion | 2009-05-28 |
| Phase | Phase 3 |
What the finished NCT00366145 record still lists
NCT00366145 is an interventional study that assigns participants to a tested intervention. The registered 260 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00366145 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00366145 about?
NCT00366145 is a clinical study titled "Efficacy and Safety of Adult Human Mesenchymal Stem Cells to Treat Steroid Refractory Acute Graft Versus Host Disease (GVHD)". The purpose of this study is to evaluate the efficacy and gather additional safety information for Prochymal® in participants who have failed to respond to steroid treatment of Grades B-D acute GVHD.
What is the current status of trial NCT00366145?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 260 participants. The study started on 2006-08-17. Estimated completion is 2009-05-28.
What interventions are being tested in trial NCT00366145?
The interventions under investigation include: Placebo (DRUG), Prochymal® (BIOLOGICAL), Standard of Care for GVHD (DRUG).
Who is sponsoring clinical trial NCT00366145?
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 NCT00366145's enrollment target sits among peer trials
260 1230th of 2000 higher than 767 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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