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

NCT00278577 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2014-02-06

No results posted yet for this study

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

Interventions

BIOLOGICAL

Immune Ablation and Hematopoietic Stem Cell Support

Autologous Hematopoietic Stem Cell Transplant

Sponsors & Collaborators

  • Richard Burt, MD

    lead OTHER

Principal Investigators

  • Robert Craig, MD · Northwestern University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-04-30
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00278577 on ClinicalTrials.gov