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NCT00543374 · ClinicalTrials.gov registry record · Phase 3
Extended Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-Resistant Moderate-to-Severe Crohn's Disease
A Phase 3 study, sponsored by Mesoblast.
- Completed
- Registry status
- Phase 3
- Development phase
- 98
- Enrollment target
NCT00543374: Completed Phase 3 study, sponsored by Mesoblast.
NCT00543374 is a Phase 3 study that has completed, run by Mesoblast. The registered enrollment target is 98 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00543374, a Phase 3 study, has completed, sponsored by Mesoblast.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 98 participants
- Enrollment target
Study Summary
Protocol 610 is enrolling subjects who successfully achieved clinical benefit (reduction in Crohn's Disease Activity Index (CDAI) of at least 100 points) in Protocol 603. Protocol 610 is evaluating the length of initial effect of PROCHYMAL® adult human mesenchymal stem cells and the ability of these cells to successfully re-induce clinical benefit.
Interventions
- DRUG Placebo
- DRUG PROCHYMAL adult human mesenchymal stem cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2007-09-17 |
| Est. Completion | 2011-04-28 |
| Phase | Phase 3 |
What the finished NCT00543374 record still lists
NCT00543374 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00543374 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00543374 about?
NCT00543374 is a clinical study titled "Extended Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-Resistant Moderate-to-Severe Crohn's Disease". Protocol 610 is enrolling subjects who successfully achieved clinical benefit (reduction in Crohn's Disease Activity Index (CDAI) of at least 100 points) in Protocol 603. Protocol 610 is evaluating the length of initial effect of PROCHYMAL® adult human mesenchymal stem cells and the ability of these...
What is the current status of trial NCT00543374?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 98 participants. The study started on 2007-09-17. Estimated completion is 2011-04-28.
What interventions are being tested in trial NCT00543374?
The interventions under investigation include: Placebo (DRUG), PROCHYMAL adult human mesenchymal stem cells (DRUG).
Who is sponsoring clinical trial NCT00543374?
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 NCT00543374's enrollment target sits among peer trials
98 1714th of 2000 higher than 283 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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