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NCT00482092 · ClinicalTrials.gov registry record · Phase 3
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
- 330
- Enrollment target
NCT00482092 is a Phase 3 study that has completed, run by Mesoblast. The registered enrollment target is 330 participants.
The verdict
NCT00482092, a Phase 3 study, has completed, sponsored by Mesoblast.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 330 participants
- Enrollment target
Study Summary
Protocol 603 is enrolling subjects with moderate-to-severe Crohn's disease who are intolerant to, or have previously failed therapy with, at least one steroid and at least one immunosuppressant and a biologic monoclonal anti-body to tumor necrosis factor alpha. The protocol investigates the safety and efficacy of using PROCHYMAL® adult human stem cells to induce remission. PROCHYMAL is delivered through a vein in the arm four times over two weeks, for approximately an hour each time.
Interventions
- DRUG Placebo
- DRUG Prochymal®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 330 participants |
| Start Date | 2007-09-17 |
| Est. Completion | 2014-09-15 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00482092
The ClinicalTrials.gov registry entry for NCT00482092 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 330 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.
NCT00482092 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00482092 about?
NCT00482092 is a clinical study titled "Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn's Disease". Protocol 603 is enrolling subjects with moderate-to-severe Crohn's disease who are intolerant to, or have previously failed therapy with, at least one steroid and at least one immunosuppressant and a biologic monoclonal anti-body to tumor necrosis factor alpha. The protocol investigates the safety a...
What is the current status of trial NCT00482092?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 330 participants. The study started on 2007-09-17. Estimated completion is 2014-09-15.
What interventions are being tested in trial NCT00482092?
The interventions under investigation include: Placebo (DRUG), Prochymal® (DRUG).
Who is sponsoring clinical trial NCT00482092?
This trial is sponsored by Mesoblast, which has 25 total clinical trials registered on ClinicalTrials.gov.
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