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Autologous Stem Cell Transplantation for Crohn's Disease

NCT00692939 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-12-15

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

autologous CD34-selected peripheral blood stem cells transplant

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

DRUG

Alemtuzumab

Transplant conditioning

DRUG

ATG

Transplant conditioning

DRUG

Melphalan

Transplant conditioning

DRUG

Thiotepa

Transplant conditioning

DRUG

Rituximab

Transplant conditioning

DRUG

Cyclophosphamide

Mobilization

DRUG

G-CSF

Mobilization

DRUG

Mesna

Mobilization

Sponsors & Collaborators

  • Paul Szabolcs

    lead OTHER

Principal Investigators

  • Paul Szabolcs, MD · University of Pittsburgh

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-26
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT00692939 on ClinicalTrials.gov