Autologous Hematopoietic Stem Cell Transplantation for Crohn's Disease Treatment (HSCT)
|ClinicalTrials.gov Identifier: NCT01932658|
Recruitment Status : Withdrawn (patients insurance would not cover the cost of the study procedures)
First Posted : August 30, 2013
Last Update Posted : April 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Biological: Hematopoietic stem cell transplantation||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Autologous Hematopoietic Stem Cell Transplantation for Crohn's Disease Treatment|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||March 2017|
Experimental: Hematopoietic stem cell transplantation
Lymphoablation followed by autologous hematopoietic stem cell transplantation rescue.
Biological: Hematopoietic stem cell transplantation
Lymphoablation followed by hematopoietic stem cell transplantation to rescue the immune system.
Other Name: HSCT
- The primary outcome to be measured is safety and clinical benefit of lymphoablation followed by autologous HSCT rescue in therapy refractory Crohn's disease. [ Time Frame: Month 1- 24 months post transplant ]Safety will be evaluated by the amount of related adverse events. All adverse events will be recorded in a standardized way and their relationship to the study protocol will be assessed at various short and long term time points.
- Disease remission [ Time Frame: 6 and 12 months post transplant ]Second, to determine clinical benefit, the percentage of patients in sustained disease remission at 0, 2, 4, 6, 12 and 24 months post HSCT will be determined. Sustained disease remission is defined as a CDAI < 150 (Appendix 1) without the use of corticosteroids. In addition, mucosal healing will be assessed during ileocolonoscopy at 6 and 12 months following HSCT using the SES endoscopic index (see under secondary endpoints
- Change in Crohn's disease endoscopic index (SES, Appendix 2) after 6 and 12 months. [ Time Frame: 6 and 12 months post transplant ]
- Change in inflammatory bowel disease questionnaire (IBD-Q) score (Appendix 3) after HSCT.
- Change in work productivity and activity impairment (WPAI) score (Appendix 4) after HSCT
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01932658
|United States, California|
|UCLA Center for Inflammatory Bowel Diseases|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Daniel W Hommes, MD,PhD||University of California, Los Angeles|