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

Status Terminated

Clinical Trial Summary

This disease is believed to be caused by immune cells (called lymphocytes) attacking tissue. Risk of death is highest in people with active acute disease. In addition, progressive Crohn's Disease leads to further loss of bowel function, which may eventually result in the need for artificial nutritional support (parenteral nutrition).

This study involves high dose chemotherapy followed by return (infusion) of blood stem cells. Stem cells are undeveloped cells that have the capacity to grow into mature blood cells, which normally circulate in the blood stream. The high dose chemotherapy consists of cyclophosphamide and anti lymphocyte antibody (a protein that depletes cells that cause damage to the body). The purpose of the intense chemotherapy is to destroy the immune system completely. The purpose of the stem cell infusion is to restore the body's blood production, which will be severely impaired by the high dose chemotherapy and anti lymphocyte antibody.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00278577
Study type	Interventional
Source	Northwestern University
Contact
Status	Terminated
Phase	Phase 1
Start date	April 2001
Completion date	February 2012

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