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NCT01659762 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study Evaluating Autologous Bone Marrow Derived Mesenchymal Stromal for Crohn's Disease.
A Phase 1 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT01659762: Completed Phase 1 study, sponsored by Emory University.
NCT01659762 is a Phase 1 study that has completed, run by Emory University. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01659762, a Phase 1 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
In this Phase I trial the investigators intend to show safety and tolerability of autologous MSC, expanded using a non-xenogeneic, human component platelet lysate expansion media. Fresh, non cryopreserved, autologous MSCs will delivered intravenously as a single bolus dose in a dose escalation phase I study. The investigators intend to test whether the product is clinically safe in adults (18-65 years old) with CD and to determine maximal deliverable dose. Secondary endpoint will monitor effectiveness using CDAI as an endpoint.
Primary Outcome
Monitoring for adverse events at time of MSC infusion and in 12 months following
Interventions
- BIOLOGICAL autologous mesenchymal stromal cell
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2012-07 |
| Phase | Phase 1 |
What the finished NCT01659762 record still lists
NCT01659762 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which autologous mesenchymal stromal cell is the first listed.
NCT01659762 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01659762 about?
NCT01659762 is a clinical study titled "A Phase I Study Evaluating Autologous Bone Marrow Derived Mesenchymal Stromal for Crohn's Disease.". In this Phase I trial the investigators intend to show safety and tolerability of autologous MSC, expanded using a non-xenogeneic, human component platelet lysate expansion media. Fresh, non cryopreserved, autologous MSCs will delivered intravenously as a single bolus dose in a dose escalation phase...
What is the current status of trial NCT01659762?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2012-07.
What interventions are being tested in trial NCT01659762?
The interventions under investigation include: autologous mesenchymal stromal cell (BIOLOGICAL).
Who is sponsoring clinical trial NCT01659762?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01659762's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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