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ASTIC Autologous Stem Cell Transplantation for Crohn's Disease | Clinical Trials | Clareo Health

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ASTIC Autologous Stem Cell Transplantation for Crohn's Disease

Autologous Stem Cell Transplantation for Crohn's Disease: ASTIC

NCT00297193•European Society for Blood and Marrow Transplantation

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age between 18 and 50 years (Patients aged 50-65 can participate if specially approved by the Trial Steering Committee)
•2. Confirmed diagnosis of active Crohn's Disease
•3. 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.
•4. Impaired function and quality of life, compared to population means, on at least one of the following:
•1. IBDQ (Appendix 6)
•2. European Questionnaire of Life quality (EuroQOL-5D, Appendix 4)
•3. Impaired function on Karnofsky index (Appendix 7)
•5. Current problems unsuitable for surgery and patient at risk for developing short bowel syndrome.
•6. Informed consent
•1. 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.
+2 more criteria

Exclusion Criteria

•1. Pregnancy or unwillingness to use adequate contraception during the study
•2. Concomitant severe disease
•3. Diarrhoea due to short small or large bowel
•4. Infection or risk thereof
•5. Significant malnutrition: Body Mass Index (BMI) ≤18, serum albumin \<20 g/l
•6. Previous poor compliance
•7. Concurrent enrolment in any other protocol using an investigational drug or hematopoietic growth factor up to four weeks before study entry.
•8. Lack of funding

Locations (19)

University Hospital Gasthuisberg

Leuven, Herestraat 49, Belgium

University of Calgery

Calgary, Alberta, Canada

Hopital Huriez Chru

Lille, France

Hospital Sanin-Louis

Paris, France

Dipatimento di Medicina Interna E Gastroenterologia

Bologna, Italy

Universita di Bologna Interna e Gastroenterologia Policlinico Saint Orsola

Bologna, Italy

Careggi Hospital

Florence, Italy

Istituto Clinico Humanitas

Milan, Italy

Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena

Milan, Italy

L Sacco University Hopsital

Milan, Italy

Key Dates

Start Date

June 1, 2006

Primary Completion Date

March 1, 2013

Completion Date

March 1, 2017

Last Updated

December 22, 2020

Enrollment

ACTUAL participants

Conditions

Crohn Disease

Interventions

Autologous haematopoietic stem cell transplant

PROCEDURE

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

NCT07245394

Inflammatory Bowel Disease (IBD)Crohn Disease (CD)+2 more

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RECRUITING

ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects

NCT07089420

IBD (Inflammatory Bowel Disease)IBS - Irritable Bowel Syndrome+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 22, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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ASTIC Autologous Stem Cell Transplantation for Crohn's Disease

Inclusion Criteria

Exclusion Criteria

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects

Immunological Characteristics of Preclinical IBD

Impact of Exclusion Diet in Addition to Anti-TNF Therapy in Crohn's Disease and Ulcerative Colitis: a Prospective, Randomized, Double-arm, Open-label Study

Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)

Robotic Inflammatory Bowel Disease Development, Learning and Efficacy Study