7th Annual BMRP Investigator Meeting - Abstract
Autologous Stem Cell Transplantation for Crohn’s Disease (ASTIC) Trial: Early Report of Toxicity and Efficacy
Chris J. Hawkey1,a, Elena Ricart2; Lisa Chalkley1, Silvio Danese3, Matthiew Allez4, Jean-Frederic Colombel5, Miranda Clarke1, Michele Simpson1
1Nottingham Digestive Diseases Centre and Biomedical Research Unit, University Hospital Nottingham (Nottingham, England); 2Hospital Clinic (Barcelona, Spain); 3Instituto Clinico Humanitas (Milan, Italy); 4Hopital Saint Louis (Lille, France); 5Hopital Huriez Chru (Lille, France)
INTRODUCTION: Some patients with Crohn’s disease are resistant to available treatments and these control but do not cure the disease. By resetting immune responses and by other mechanisms, autologous stem cell transplantation has the potential to cure Crohn’s disease. Case reports suggest this is the case for some but not all patients.
AIMS & METHODS: The ASTIC Trial randomises patients with poor quality of life despite three immunosuppresive agents to undergo stem cell mobilisation followed by ablation and transplantation immediately or after one year, and compares the number in drug free clinical and endoscopic remission at the end of one year.
RESULTS: Eighteen patients have been considered by the Steering Committee. Eight have been approved unconditionally and five subject to specific improvements in health or management. Nine patients who have entered the study are shown in the Table. Four patients did not proceed to trial entry because of spontaneous improvements. As at November 1 2008, four serious adverse events have been reported (three infective, three serious, one SUSARs). Data on efficacy will be analysed on March 1 2009 and will be presented.
CONCLUSION: There are a significant number of patients with Crohn’s disease for whom stem cell transplantation is an appropriate course of action. The main risks are related to infection.
AIMS & METHODS: The ASTIC Trial randomises patients with poor quality of life despite three immunosuppresive agents to undergo stem cell mobilisation followed by ablation and transplantation immediately or after one year, and compares the number in drug free clinical and endoscopic remission at the end of one year.
RESULTS: Eighteen patients have been considered by the Steering Committee. Eight have been approved unconditionally and five subject to specific improvements in health or management. Nine patients who have entered the study are shown in the Table. Four patients did not proceed to trial entry because of spontaneous improvements. As at November 1 2008, four serious adverse events have been reported (three infective, three serious, one SUSARs). Data on efficacy will be analysed on March 1 2009 and will be presented.
CONCLUSION: There are a significant number of patients with Crohn’s disease for whom stem cell transplantation is an appropriate course of action. The main risks are related to infection.
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aPrincipal Investigator