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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 is a Phase 1 study that has completed, run by Emory University. The registered enrollment target is 16 participants.
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.
Interventions
- BIOLOGICAL autologous mesenchymal stromal cell
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2012-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01659762
The ClinicalTrials.gov registry entry for NCT01659762 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which autologous mesenchymal stromal cell is the first listed.
NCT01659762 reports 0 study locations.
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.
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