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Immune Ablation and Stem Cell Support for Crohn's Disease | Clinical Trials | Clareo Health

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Immune Ablation and Stem Cell Support for Crohn's Disease

Immune Ablation and Hematopoietic Stem Cell Support in Patients With Severe Crohn's Disease

NCT00179842•Ann & Robert H Lurie Children's Hospital of Chicago

Summary

The investigators anticipate that this study will also form the basis to clarify further the role of the immune system in Crohn's disease.

Detailed Description

This study 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 stem cells. Subsequent disease activity will be followed by (1) Crohn's disease activity index (CDAI), (2) quality of life instrument (IBDQ), (3) type and amount of therapy for CD, and (4) flow cytometry of peripheral blood lymphocyte subsets. In addition, the subjects will undergo periodic absorption function testing, to assess small intestinal function. We anticipate that this study will also form the basis to clarify further the role of the immune system in Crohn's disease.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Less than physiologic age 60 at time of pretransplant evaluation.
•An established clinical diagnosis of severe CD that has failed therapy with prednisone, azathioprine, 5 ASA products and metronidazole, and has failed to have a sustained decrement of 70 points in the CDAI after one course of anti-TNF alpha, Infliximad. The patient is being considered for therapy with cyclosporin A (CSA) or surgical resection. The CDAI (appendix A) is 250-400.
•Pre-study peripheral blood counts must include a platelet count greater than 100,000/ul and an absolute neutrophil count greater than 1500/ul.
•Stem cell harvest greater than 1.4 x 106 CD34 cells/kg after CD34+ selection (to continue to transplant.)

Exclusion Criteria

•HIV positive
•History of coronary artery disease, or congestive heart failure.
•Uncontrolled diabetes mellitus, or any other illness that in the opinion of the investigators would jeopardize the ability of the patient to tolerate aggressive chemotherapy
•Prior history of malignancy except localized basal cell or squamous skin cancer. Other malignancies for which the patient is judged to be cured by local surgical therapy, such as head and neck cancer, or stage I breast cancer will be considered on an individual basis.
•Positive pregnancy test, lactation, inability or unwillingness to pursue effective means of birth control, failure to accept or comprehend irreversible sterility as a side effect of therapy.
•Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible.
•FEV I/FVC \< 50% of predicted, DLCO \< 50% of predicted.
•Resting LVEF \< 40%
•Bilirubin \> 2.0 mg/dl, transferase (AST) \> 2x upper limit of normal, unless the abnormalities are secondary to Crohn's disease.
•Serum creatinine \> 2.0 mg/dl.
+2 more criteria

Locations (1)

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Key Dates

Start Date

March 22, 2007

Primary Completion Date

December 19, 2008

Completion Date

December 19, 2008

Last Updated

February 10, 2025

Conditions

Crohn Disease

Interventions

Stem Cell Transplant

PROCEDURE

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

NCT07245394

Inflammatory Bowel Disease (IBD)Crohn Disease (CD)+2 more

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RECRUITING

ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects

NCT07089420

IBD (Inflammatory Bowel Disease)IBS - Irritable Bowel Syndrome+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Immune Ablation and Stem Cell Support for Crohn's Disease

Inclusion Criteria

Exclusion Criteria

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects

Immunological Characteristics of Preclinical IBD

Impact of Exclusion Diet in Addition to Anti-TNF Therapy in Crohn's Disease and Ulcerative Colitis: a Prospective, Randomized, Double-arm, Open-label Study

Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)

Robotic Inflammatory Bowel Disease Development, Learning and Efficacy Study