*Crohn's Disease Treatment using Blood Stem Cells – Phase I/II

Protocol Description

This study evaluates the safety and effectiveness of administering high-dose chemotherapy followed by infusion of the patient’s own CD34-selected peripheral blood stem cells (PBSC) in pediatric and young adult patients with severe Crohn's disease. Crohn's disease may be caused or aggravated by the individual's own immune system. The goal of the study is to try to reset the immune system. The chemotherapy is intended to remove or reduce the patient’s immune cells so they can be replaced with CD34 stem cells, which researchers believe will mature into immune cells that will not cause the inflammation associated with Crohn's disease.

Study Level: Phase I/II

Eligibility Criteria

Subject to certain exclusion criteria, the study is accepting participants of both genders between the ages of 5 and 60 who have been diagnosed with severe Crohn’s disease.
Males: 5 to 60 years old
Females: 5 to 60 years old

Requirements

This study requires several weeks of hospitalization. Prior to transplant, stem cells will be harvested from the patient’s peripheral blood (PBSC). A regimen of chemotherapy will be provided within the hospital setting. Following that, patients will receive, via infusion, a transplant of their own CD34-selected PBSCs.
Visits: Requires hospitalization for several weeks of conditioning prior to transplant 
Duration: 5 years for follow up

Status: Open for Enrollment

Source(s) of Support

Miltenyi Biotec GmbH

Additional Information

Study Description from the National Institutes of Health

Primary Investigator

Paul Szabolcs, MD

Contact Information

For information about the study or enrollment, please contact:
Shawna McIntyre, Clinical Research Supervisor
412-692-5552