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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 is a Phase 3 study that has completed, run by Mesoblast. The registered enrollment target is 98 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00543374
The ClinicalTrials.gov registry entry for NCT00543374 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 98 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 Placebo is the first listed.
NCT00543374 reports 0 study locations.
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.
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