NCT00297193

ASTIC Autologous Stem Cell Transplantation for Crohn's Disease

Autologous Stem Cell Transplantation for Crohn's Disease: ASTIC

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: European Society for Blood and Marrow Transplantation · Network
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-06-01
• Primary completion: 2013-03-01
• Completion: 2017-03-01
• First posted: 2006-02-28
• Last updated: 2020-12-22

Locations

19 sites across 7 countries: Belgium, Canada, France, Italy, Spain, Switzerland, United Kingdom