Immune Ablation and Stem Cell Support for Crohn's Disease
The investigators anticipate that this study will also form the basis to clarify further the role of the immune system in Crohn's disease.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Immune Ablation and Hematopoietic Stem Cell Support in Patients With Severe Crohn's Disease|
- To investigate the safety and efficacy of treating severe CD with high dose cyclophosphamide and antithymocyte globulin rescued with T cell depleted autologous stem cells. Data will be used to evaluate the efficiency of a future phase III protocol. [ Time Frame: Minimum of 2 years ] [ Designated as safety issue: Yes ]
|Estimated Study Completion Date:||December 2008|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00179842
|United States, Illinois|
|Children's Memorial Hospital|
|Chicago, Illinois, United States, 60614|
|Principal Investigator:||Morris Kletzel, M.D.||Ann & Robert H Lurie Children's Hospital of Chicago|