Status:
TERMINATED
ASTIC Autologous Stem Cell Transplantation for Crohn's Disease
Lead Sponsor:
European Society for Blood and Marrow Transplantation
Collaborating Sponsors:
The Broad Foundation
Conditions:
Crohn Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 potent...
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 und...
Eligibility Criteria
Inclusion
- Inclusion criteria: mandatory
- Age between 18 and 50 years (Patients aged 50-65 can participate if specially approved by the Trial Steering Committee)
- Confirmed diagnosis of active Crohn's Disease
- Unsatisfactory course despite 3 immunosuppressive agents (usually azathioprine, methotrexate and infliximab) in addition to corticosteroids. Patients should have relapsing disease (i.e. \>1 exacerbation/year) despite thiopurines, methotrexate and/or infliximab maintenance therapy or clear demonstration of intolerance / toxicity to these drugs.
- Impaired function and quality of life, compared to population means, on at least one of the following:
- IBDQ (Appendix 6)
- European Questionnaire of Life quality (EuroQOL-5D, Appendix 4)
- Impaired function on Karnofsky index (Appendix 7)
- Current problems unsuitable for surgery and patient at risk for developing short bowel syndrome.
- Informed consent
- Inclusion criteria: discretionary
- Wherever possible, diseased tissue should be accessible endoscopically for objective histological study but in the case of small bowel disease that is extensive but does not extend to duodenum or terminal ileum, participation without endoscopy is allowed.
- Smokers may enter the study provided they have received intensive counselling about smoking.
- Add patients with ileostomy/colostomy and patients with short bowel syndrome
Exclusion
- Pregnancy or unwillingness to use adequate contraception during the study
- Concomitant severe disease
- Diarrhoea due to short small or large bowel
- Infection or risk thereof
- Significant malnutrition: Body Mass Index (BMI) ≤18, serum albumin \<20 g/l
- Previous poor compliance
- Concurrent enrolment in any other protocol using an investigational drug or hematopoietic growth factor up to four weeks before study entry.
- Lack of funding
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00297193
Start Date
June 1 2006
End Date
March 1 2017
Last Update
December 22 2020
Active Locations (19)
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1
University Hospital Gasthuisberg
Leuven, Herestraat 49, Belgium, 3000
2
University of Calgery
Calgary, Alberta, Canada, T2N 2T9
3
Hopital Huriez Chru
Lille, France, 59037
4
Hospital Sanin-Louis
Paris, France, 75010