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

Launched by RICHARD BURT, MD · Jan 15, 2006

Keywords

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Less than physiologic age 60 at time of pretransplant evaluation
• • 2. 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) 250-400 or a Craig Severity Score that is \> 17 (appendix D)
• • 3. Pre-study peripheral blood counts must include a platelet count greater than 100,000/ul and an absolute neutrophil count greater than 1500/ul.
• • 4. Stem cell harvest greater than 1.4 x 106 CD34 cells/kg after CD34+ selection (to continue to transplant)
• • 5. Ability to give informed consent
• • Exclusion Criteria
• • 1. HIV positive
• • 2. History of coronary artery disease, or congestive heart failure
• • 3. 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
• • 4. 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
• • 5. 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
• • 6. Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible
• • 7. FEV I/FVC \< 50% of predicted, DLCO \< 50% of predicted
• • 8. Resting LVEF \< 40%
• • 9. Bilirubin \> 2.0 mg/dl, transferase (AST) \> 2x upper limit of normal, unless the abnormalities are secondary to Crohn's disease
• • 10. Serum creatinine \> 2.0 mg/dl
• • 11. Platelet count less than 100,000/ul, ANC less than 1500/ul
• • 12. 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.

Trial Officials