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NCT02150551 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability Of Allogeneic Mesenchymal Stromal Cells in Pediatric Inflammatory Bowel Disease
A Phase 1 study, sponsored by Catherine Bollard.
- Completed
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT02150551: Completed Phase 1 study, sponsored by Catherine Bollard.
NCT02150551 is a Phase 1 study that has completed, run by Catherine Bollard. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02150551, a Phase 1 study, has completed, sponsored by Catherine Bollard.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
In this trial, investigators will infuse donor bone marrow mesenchymal stromal cells intravenously, as a treatment for pediatric Crohn's disease or ulcerative colitis that has not responded to conventional therapies. The goals of this study are to test the safety and tolerability of donor mesenchymal stromal cells in children with Inflammatory Bowel Disease. Mesenchymal stromal cells support the development of blood cells within the bone marrow. When isolated from a donor and infused into an animal or human, they have been demonstrated to travel to areas of inflammation, to alter immune responses, to decrease pro-inflammatory cytokines, and to promote tissue repair. Infusion of these cells does not lead to rejection. These properties lead investigators to hypothesize that that these may be they may be beneficial in treating inflammatory bowel disease.
Primary Outcome
Safety and tolerability of the administration of human allogeneic bone marrow-derived stromal cells to children and young adults with IBD, measured by the frequency of any SAEs, AEs and/or early treatment discontinuations. Weekly infusions for 8 weeks, post-treatment assessment 45 days after last infusion, three additional follow-up visits over 2 years.
Interventions
- BIOLOGICAL Allogeneic bone marrow-derived mesenchymal stromal cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2018-06-07 |
| Est. Completion | 2018-09-05 |
| Phase | Phase 1 |
What the finished NCT02150551 record still lists
NCT02150551 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Allogeneic bone marrow-derived mesenchymal stromal cells is the first listed.
NCT02150551 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02150551 about?
NCT02150551 is a clinical study titled "Safety and Tolerability Of Allogeneic Mesenchymal Stromal Cells in Pediatric Inflammatory Bowel Disease". In this trial, investigators will infuse donor bone marrow mesenchymal stromal cells intravenously, as a treatment for pediatric Crohn's disease or ulcerative colitis that has not responded to conventional therapies. The goals of this study are to test the safety and tolerability of donor mesenchyma...
What is the current status of trial NCT02150551?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2018-06-07. Estimated completion is 2018-09-05.
What interventions are being tested in trial NCT02150551?
The interventions under investigation include: Allogeneic bone marrow-derived mesenchymal stromal cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT02150551?
This trial is sponsored by Catherine Bollard, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02150551's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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