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Trial record 18 of 970 for:    stem cells | Studies With Results

Crohn's Disease Stem Cell Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00271947
Recruitment Status : Terminated (The PI, who was sponsor got retired)
First Posted : January 4, 2006
Results First Posted : March 27, 2014
Last Update Posted : March 27, 2014
Information provided by (Responsible Party):
Richard Burt, MD, Northwestern University

Brief 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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Biological: Autologous Stem Cell Transplantation Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Crohn's Disease Non-myeloablative Autologous Hematopoietic Stem Cell Transplantation (CDNST) Versus Standard Therapy
Study Start Date : April 2005
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: Autologous Stem Cell Transplantation
Autologous Stem Cell Transplantation will be performed after the conditioning regimen
Biological: Autologous Stem Cell Transplantation
Autologous Stem Cell Transplantation will be performed after conditioning regimen

Primary Outcome Measures :
  1. Number of Participants With Remission or Clinical Improvement as Assessed by Crohn's Disease Activity Index (CDAI) Scores [ Time Frame: baseline ]
    Clinical remission defined as a CDAI less than 150 and clinical improvement defined as decline in CDI> or = 70 one year following entry. The participant was not assessed according to the criteria of the outcome measure, because the participant was lost for follow-up.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18 years or older and less than age 55 years 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 an anti-TNF alpha inhibitor. Failure is defined as a CDAI (appendix A) 225-400.
  • Pre-study peripheral blood counts must include a platelet count greater than 100,000/ul and an absolute neutrophil count greater than 1500/ul.
  • In those randomized to receive the transplant, a stem cell harvest greater than 2.0 x 106 CD34 cells/kg is required.
  • Ability to give informed consent.

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 1/FVC < 50% of predicted, DLCO < 50% of predicted.
  • Resting LVEF < 40%.
  • Bilirubin > 2.0 mg/dl, transferase (AST) > 2x upper limit of normal.
  • Serum creatinine > 2.0 mg/dl.
  • Platelet count less than 100,000/ul, ANC less than 1500/ul.
  • Patients presenting with intestinal perforation or toxic megacolon, or a suppurative problem that will require urgent surgery. In addition, the patient may not have any active infection. The presence of intestinal stomas does not exclude the patient from study.
  • Splenomegaly (palpable spleen on physical exam).
  • Inability to collect > 2.0 x 106 CD34+ cells/kg.
  • Positive pregnancy test.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00271947

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United States, Illinois
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
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Principal Investigator: Robert Craig, MD Northwestern University

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Responsible Party: Richard Burt, MD, MD, Northwestern University Identifier: NCT00271947     History of Changes
Other Study ID Numbers: CD Randomized
First Posted: January 4, 2006    Key Record Dates
Results First Posted: March 27, 2014
Last Update Posted: March 27, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases