ASTIC Autologous Stem Cell Transplantation for Crohn's Disease

Status Terminated

Clinical Trial 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.

Clinical Trial Description

Open label, phase III, randomised, multicentre study comparing early transplantation procedure with transplantation carried out to the same protocol but delayed by one year. The status of patients undergoing early HSCT will be evaluated after one year and compared to those about to undergo delayed HSCT Patients will be randomised to: - Hematopoietic stem cell mobilisation followed, within 4 weeks, by high dose immunoablation and autologous stem cell transplantation - Hematopoietic stem cell mobilisation followed, after 59 weeks, by high dose immunoablation and autologous hematopoietic stem cell transplantation 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. ;

Study Design

Related Conditions & MeSH terms

Crohn Disease

Clinical Trial Details

NCT number	NCT00297193
Study type	Interventional
Source	European Group for Blood and Marrow Transplantation
Contact
Status	Terminated
Phase	Phase 3
Start date	June 2006
Completion date	March 2017

View Details

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