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NCT00271947 · ClinicalTrials.gov registry record · Phase 2
Crohn's Disease Stem Cell Transplantation
A Phase 2 study, sponsored by Northwestern University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT00271947 is a Phase 2 study that was terminated before completion, run by Northwestern University. The registered enrollment target is 1 participants.
The verdict
NCT00271947, a Phase 2 study, was terminated before completion, sponsored by Northwestern University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
Crohn's disease (CD) is a chronic illness, immunologically mediated, probably induced by the exposure of the intestine to an antigen or antigens similar to the intestine, to which immunologic tolerance is lost or a dysregulated immunity ensues. The disease has a variable course, from a mild, intermittently active illness requiring only symptomatic therapy to a fulminant illness requiring potentially dangerous immunosuppressive therapy, surgery or both. The molecular defect causing CD has not been characterized, but probably involves aberrant T cell function. Although CD often responds to immunosuppressive medication including corticosteroids, azathioprine and 6-mercaptopurine, to anti inflammatory drugs such as 5 aminosalicylate (5 ASA), or to some antimicrobial agents, including metronidazole, no therapy has been curative. In patients with severe CD, who have been unresponsive to corticosteroids, azathioprine, 5 ASA, metronidazole, and infliximab, we propose to compare the efficacy of Crohn's disease non-myeloablative autologous hematopoietic stem cell transplantation (CDNST) to standard therapy. Subsequent disease activity will be followed by (1) Crohn's disease activity index (CDAI), (2) a more global severity index, the Crohn's Severity Index, (3) type and amount of therapy for CD, and (4) clinical, hematologic and biochemical studies.
Interventions
- BIOLOGICAL Autologous Stem Cell Transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2005-04 |
| Est. Completion | 2013-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00271947
The ClinicalTrials.gov registry entry for NCT00271947 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 1 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 Autologous Stem Cell Transplantation is the first listed.
NCT00271947 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00271947 about?
NCT00271947 is a clinical study titled "Crohn's Disease Stem Cell Transplantation". Crohn's disease (CD) is a chronic illness, immunologically mediated, probably induced by the exposure of the intestine to an antigen or antigens similar to the intestine, to which immunologic tolerance is lost or a dysregulated immunity ensues. The disease has a variable course, from a mild, intermi...
What is the current status of trial NCT00271947?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2005-04. Estimated completion is 2013-04.
What interventions are being tested in trial NCT00271947?
The interventions under investigation include: Autologous Stem Cell Transplantation (BIOLOGICAL).
Who is sponsoring clinical trial NCT00271947?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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