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NCT01288053 · ClinicalTrials.gov registry record · Phase 1
Non-myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Refractory Crohn's Disease
A Phase 1 study, sponsored by Northwestern University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT01288053 is a Phase 1 study that was terminated before completion, run by Northwestern University. The registered enrollment target is 9 participants.
The verdict
NCT01288053, a Phase 1 study, was terminated before completion, sponsored by Northwestern University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
Allogeneic transplantation has been a high-risk procedure, although non-myeloablative conditioning regimens (mini-transplantation) minimizes regimen related toxicity. The investigators, therefore, propose a phase I study of matched sibling allogeneic hematopoietic stem cell transplantation with non-myeloablative conditioning. In addition, graft versus host disease (GVHD) will be virtually eliminated by CAMPATH that removes donor T cells from the graft. The goal is to assess the toxicity/efficacy (phase I) of allogeneic non-myeloablative hematopoietic stem cell transplantation for high-risk Crohn's disease. In simplistic terms, this protocol is designed to ablate an aberrant immune system and then, similar to the use of marrow transplants for immunodeficient patients, reconstitute a new immune system with lymphocyte depleted marrow.
Interventions
- BIOLOGICAL Allogeneic Stem Cell Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2010-01 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01288053
The ClinicalTrials.gov registry entry for NCT01288053 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Allogeneic Stem Cell Therapy is the first listed.
NCT01288053 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01288053 about?
NCT01288053 is a clinical study titled "Non-myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Refractory Crohn's Disease". Allogeneic transplantation has been a high-risk procedure, although non-myeloablative conditioning regimens (mini-transplantation) minimizes regimen related toxicity. The investigators, therefore, propose a phase I study of matched sibling allogeneic hematopoietic stem cell transplantation with non-...
What is the current status of trial NCT01288053?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2010-01. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01288053?
The interventions under investigation include: Allogeneic Stem Cell Therapy (BIOLOGICAL).
Who is sponsoring clinical trial NCT01288053?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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