| Welcome to the ASTIC trial
(Autologous Stem Cell Transplantation for Crohn's Disease)
A multicentre, prospective, randomised phase III study conducted by the European Crohn’s and Colitis Organisation (ECCO), sponsored by the Autoimmune Disease Working Party of the European Group for Blood and Marrow Transplantation (EBMT)
If you are a patient interested in finding out more about the trial, please click on the Patient Information link.
If you are a doctor interested in getting involved in the trial, or would like to find out more detailed information, please use the other links. The Members Only page is for the use of doctors already involved in the trial, and the ASTIC study administration office can give you login details to access this page.
Latest news about the study:
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Date |
News |
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July 2009 |
Study Update
14 patients now consented into the trial, with 7 transplants complete. Sites with patients in trial include UK(London, Oxford, Norfolk and Norwich), France(Paris, Lille), Spain(Barcelona), Italy(Milan).
New UK sites include Edinburgh, BARTS and The London and Kilmarnock. Sites ready to recruit in Switzerland include Basel, Zurich and Lausanne; in Germany, Berlin; and in the Czech Republic, Prague. In Italy, there are sites planned in Florence, Bologna, Rome, Palermo, San Giovanni Rotondo, Genova, Ferrara and Aviano. |
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November 2008 |
Barcelona Storms Ahead
Well done to Elena Ricart and team who have registered 5 patients so far and have a further patient to be discussed by the Trial Steering Committee. Although her first patient withdrew after mobilisation, 2 have been randomised to the early transplant group. One received the transplant in July and the other undergoes transplantation this month. With 2 other patients already completed pre-registration assessments, this unit is certainly very busy.
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July 2008 |
First Transplants Completed
The first patient registered for the trial, based at Nottingham University Hospital with Chris Hawkey, has had to wait a year for his transplant. This is now complete and we wish him a speedy recovery. At the same time, the first patient randomised to early tranplant had their procedure in Barcelona.
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February 2008 |
Three Sites Now Recruiting
Nottingham, Oxford and Barcelona have now completed trial registration. Each has one patient registered and of these, 2 have been randomised.
Other sites close to finalising their trial authorisations include France (Paris and Lille), Italy (Bologna, Florence, Rome, Palermo and Milan), Switzerland (Basel and Lausanne), Czech Republic (Prague) and Canada (Edmonton and Calgary). Alot of hard work has gone on and these sites are being encouraged to put forward potential patients for discussion so things could move quickly in the next few months.
Germany, Netherlands, Belgium, Austria and Ireland are also countries working hard to register their centres.
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19th July 2007 |
First Patient Recruited
DG, a patient with extensive small and large bowel Crohn’s Disease and continuing symptoms despite maximal therapy is currently undergoing baseline evaluations. He will undergo mobilisation at the end of July and randomisation in August. Following behind there is a female patient in Lille who is starting baseline evaluations and others imminent, dependant upon approvals in Italy, Switzerland, Spain and the Czech Republic.
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July 2007
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Update on Clinical Trial Registrations
The complexity of legislation has made it difficult to get the trial registered in the various countries intended. However we now have good news – the UK is fully registered and approved as are France (thank you to Dominique Farge for the approval work and to David Seguy and Jean Fredrick Colombel for recruitment) and Canada (thank you to Michelle Geddes and colleagues). A small item of local approval needs to be resolved and the Czech Republic (thank you to Milan Lukas) will then be recruiting. Switzerland is the latest country to submit (thank you to Stephan Svavricka, Christoph Beglinger and Gerhard Rogler). Thank you also to Elena Ricart and Julian Panes who have moved things forward rapidly in Spain with ethical approval and awaiting Government Clinical Trials Authorisation. There is also progress in Italy.
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July 2007 |
CJH Tours the World!
I have now visited four of the participating countries. It has been a very interesting experience to see other peoples units and it seems to have been helpful in moving approvals forward.
In Barcelona we made great progress so that we now have ethics approval (thank you to Elena Ricart , Julian Panes and Xavier Carne).
Similarly a trip to Switzerland has results in submission for ethical approval (thank you to Stephan Vavricka and Christoph Beglinger ) – this will help to get the two urgent cases from Lausanne and Zurich into the trial soon.
In Rome I had a very interesting ‘Meet the Professor Day’ with Franco Pallone which we discussed 5 cases, 2 of which seem highly suitable and will be discussed at a teleconference soon.
Similarly in the Czech Republic it was very nice to meet three of the four patients under consideration.
On some of these trips I was accompanied by the Clinical Trials Staff, if you think they or I could help you with submission or other aspects of the trial, please don’t hesitate to ask.
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This study is funded by a grant from the Broad Medical Research Programme.
The Chief Investigator for the study is:
Professor Chris Hawkey, Wolfson Digestive Diseases Centre, University Hospital, Nottingham NG7 2UH, UK.
The Study Administration Office, who are co-ordinating the trial, can be contacted at:
ASTIC Study Administration Office, Wolfson Digestive Diseases Centre, University Hospital, Nottingham NG7 2UH, UK.
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