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Sponsored by: |
Northwestern University |
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Information provided by: | Northwestern University |
ClinicalTrials.gov Identifier: | NCT00271947 |
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.
Condition | Intervention | Phase |
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Crohn's Disease |
Procedure: stem cell transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Crohn's Disease Non-Myeloablative Autologous Hematopoietic Stem Cell Transplantation (CDNST) Versus Standard Therapy |
Estimated Enrollment: | 110 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | April 2015 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dzemila Spahovic, MD | 312-908-0059 | d-spahovic@northwestern.edu |
United States, Illinois | |
Northwestern University, Feinberg School of Medicine | Recruiting |
Chicago, Illinois, United States, 60611 | |
Principal Investigator: Robert Craig, MD | |
Principal Investigator: Richard Burt, MD | |
Sub-Investigator: Kathleen Quigley, R.N.; M.B.A | |
Sub-Investigator: Kimberly Yaung, R.N. |
Principal Investigator: | Robert Craig, MD | Northwestern University |
Responsible Party: | Northwestern University ( Robert Craig, MD ) |
Study ID Numbers: | CD Randomized |
Study First Received: | January 2, 2006 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00271947 |
Health Authority: | United States: Food and Drug Administration |
Digestive System Diseases Gastrointestinal Diseases Crohn Disease |
Inflammatory Bowel Diseases Gastroenteritis Intestinal Diseases |