MedTrace Logo

ASTIC Autologous Stem Cell Transplantation for Crohn's Disease

NCT00297193 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-12-22

No results posted yet for this study

Summary

Transplant study for patients with relapsing Crohn's disease demonstrating clear intolerance or toxicity to conventional treatment.

The purpose of this study is to determine whether there is a potential clinical benefit of hematopoietic stem cell mobilisation followed by high dose immuno-ablation and autologous stem cell transplantation versus hematopoietic stem cell mobilisation only followed by best clinical practice.

Conditions

  • Crohn Disease

Interventions

PROCEDURE

Autologous haematopoietic stem cell transplant

All patients will be mobilised prior to randomisation. Those receiving early transplantation will be compared over the first year with those whose transplant has been delayed.

Sponsors & Collaborators

  • The Broad Foundation

    collaborator OTHER

  • European Society for Blood and Marrow Transplantation

    lead NETWORK

Principal Investigators

  • Christopher J Hawkey · Nottingham University Hospital - Wolfson Digestive Diseases Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2013-03-31
Completion
2017-03-31

Countries

  • Belgium
  • Canada
  • France
  • Italy
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

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 NCT00297193 on ClinicalTrials.gov