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NCT00284986 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Prochymal for the Salvage of Treatment-Refractory Acute GVHD Participants
A Phase 2 study, sponsored by Mesoblast.
- Completed
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT00284986: Completed Phase 2 study, sponsored by Mesoblast.
NCT00284986 is a Phase 2 study that has completed, run by Mesoblast. The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00284986, a Phase 2 study, has completed, sponsored by Mesoblast.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
This study is designed to evaluate the safety and efficacy of Prochymal® (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) in participants experiencing treatment-refractory acute GVHD, Grades III-IV, that is refractory to standard first-line therapies and at least one second-line therapy.
Primary Outcome
Responses included complete response (CR), partial response (PR), failure to respond. CR is defined as a complete resolution of graft-versus-host disease (GVHD). PR is defined as improvement in at least one organ by at least one full stage in the absence of progression in any other organ, or resolution of GVHD in at least one organ with a need for additional treatment because of abnormalities persisting in another organ. Failure to respond is defined as progression of GVHD.
Interventions
- DRUG Prochymal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2005-11-18 |
| Est. Completion | 2007-02-08 |
| Phase | Phase 2 |
What the finished NCT00284986 record still lists
NCT00284986 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Prochymal is the first listed.
NCT00284986 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00284986 about?
NCT00284986 is a clinical study titled "Safety and Efficacy of Prochymal for the Salvage of Treatment-Refractory Acute GVHD Participants". This study is designed to evaluate the safety and efficacy of Prochymal® (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) in participants experiencing treatment-refractory acute GVHD, Grades III-IV, that is refractory to standard first-line therapies and at least one second-line therapy.
What is the current status of trial NCT00284986?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2005-11-18. Estimated completion is 2007-02-08.
What interventions are being tested in trial NCT00284986?
The interventions under investigation include: Prochymal (DRUG).
Who is sponsoring clinical trial NCT00284986?
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 NCT00284986's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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