NCT00278577

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Richard Burt, MD · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• CROHN'S DISEASE

Interventions

Type	Name	Description
BIOLOGICAL	Immune Ablation and Hematopoietic Stem Cell Support	Autologous Hematopoietic Stem Cell Transplant

Timeline

• Start date: 2001-04-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2006-01-18
• Last updated: 2014-02-06

Locations

1 site across 1 country: United States