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NCT02336230 · ClinicalTrials.gov registry record · Phase 3
A Prospective Study of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Stromal Cells, for the Treatment of Pediatric Participants Who Have Failed to Respond to Steroid Treatment for Acute Graft-Versus-Host Disease (aGVHD)
A Phase 3 study, sponsored by Mesoblast.
- Completed
- Registry status
- Phase 3
- Development phase
- 55
- Enrollment target
NCT02336230: Completed Phase 3 study, sponsored by Mesoblast.
NCT02336230 is a Phase 3 study that has completed, run by Mesoblast. The registered enrollment target is 55 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02336230, a Phase 3 study, has completed, sponsored by Mesoblast.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 55 participants
- Enrollment target
Study Summary
The study plans to treat at least 60 pediatric participants, male and female, between the ages of 2 months and 17 years inclusive with aGVHD following allogeneic hematopoietic stem cell transplant (HSCT) that has failed to respond to treatment with systemic corticosteroid therapy. Participants may have Grades C and D aGVHD involving the skin, liver and/or gastrointestinal (GI) tract or Grade B aGVHD involving the liver and/or GI tract, with or without concomitant skin disease.
Primary Outcome
ORR was defined as the percentage of participants who had achieved overall response. Overall response was defined as complete response (CR) plus partial response (PR) as per aGVHD response criteria. CR was defined as resolution of aGVHD in all involved organs. PR was defined as organ improvement of at least 1 stage without worsening of any other organ.
Interventions
- DRUG remestemcel-L
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2015-06-04 |
| Est. Completion | 2018-04-09 |
| Phase | Phase 3 |
What the finished NCT02336230 record still lists
NCT02336230 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which remestemcel-L is the first listed.
NCT02336230 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02336230 about?
NCT02336230 is a clinical study titled "A Prospective Study of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Stromal Cells, for the Treatment of Pediatric Participants Who Have Failed to Respond to Steroid Treatment for Acute Graft-Versus-Host Disease (aGVHD)". The study plans to treat at least 60 pediatric participants, male and female, between the ages of 2 months and 17 years inclusive with aGVHD following allogeneic hematopoietic stem cell transplant (HSCT) that has failed to respond to treatment with systemic corticosteroid therapy. Participants may h...
What is the current status of trial NCT02336230?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 55 participants. The study started on 2015-06-04. Estimated completion is 2018-04-09.
What interventions are being tested in trial NCT02336230?
The interventions under investigation include: remestemcel-L (DRUG).
Who is sponsoring clinical trial NCT02336230?
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 NCT02336230's enrollment target sits among peer trials
55 1834th of 2000 higher than 163 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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