RecruitingPhase 1Phase 2NCT00692939

Autologous Stem Cell Transplantation for Crohn's Disease

Autologous Stem Cell Transplantation With CD34-Selected Peripheral Blood Stem Cells (PBSC) in Pediatric and Adult Patients With Severe Crohn's Disease


Sponsor

Paul Szabolcs

Enrollment

20 participants

Start Date

Jun 26, 2012

Study Type

INTERVENTIONAL

Conditions

Summary

The objective of this study is to evaluate the safety and effectiveness of administering high-dose chemotherapy followed by infusion of autologous CD34-selected peripheral blood stem cells (PBSC) in pediatric and adult patients with severe Crohn's disease.


Eligibility

Min Age: 10 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether resetting a patient's immune system using their own stem cells (a procedure called autologous stem cell transplantation) can provide long-term remission in people with severe Crohn's disease that has not responded to other treatments. **You may be eligible if...** - You have severe Crohn's disease (a chronic inflammatory bowel condition) - Your disease has not responded to multiple standard treatments including biologics and immunosuppressants - You are between 18 and 50 years of age with no serious organ damage **You may NOT be eligible if...** - You have a serious infection that is not under control - Your heart, lung, kidney, or liver function is significantly impaired - You have had previous stem cell transplantation - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALautologous CD34-selected peripheral blood stem cells transplant

high-dose immunotherapy followed by infusion of autologous CD34-selected peripheral blood stem cells (PBSC)

DRUGAlemtuzumab

Transplant conditioning

DRUGATG

Transplant conditioning

DRUGMelphalan

Transplant conditioning

DRUGThiotepa

Transplant conditioning

DRUGRituximab

Transplant conditioning

DRUGCyclophosphamide

Mobilization

DRUGG-CSF

Mobilization

DRUGMesna

Mobilization


Locations(2)

UPMC Prebyterian- Adult Gastroenterology

Pittsburgh, Pennsylvania, United States

Children's Hospital of Pittsburgh of UPMC-Bone Marrow Team

Pittsburgh, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT00692939


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