ASTIClite - Autologous Stem cell Transplantation In refractory Crohn’s disease – Low Intensity Therapy Evaluation
The ASTIClite trial aims to assess whether stem cell transplantation, with a low intensity treatment regimen, can reduce the symptoms and activity of Crohn’s disease and enhance quality of life, compared to current standard care. The trial will also assess the safety of the procedure, explore the mechanisms involved in immune reconstitution and whether patients who do experience recurrent disease after the stem cell transplant will respond to treatments which had not worked previously. Finally, we will assess the long-term safety and efficacy in patients undergoing stem cell transplantation over a minimum of a further 4 years.
ASTIClite has quite strict eligibility criteria. Briefly, the trial is aimed at people who are aged 18-60, with a diagnosis of active Crohn’s disease for at least six months, where at least two classes of biologic therapy have been tried, but have not worked, and where surgery is not appropriate. There are further inclusion and exclusion criteria that participants must also satisfy in order to take part.
There are eight participating centres around the UK, two of which are currently open to recruitment (Barts Health and Sheffield). Participating sites welcome referrals from Gastroenterology colleagues. To find out where your nearest site is in order to make a referral please contact the study team: ASTIClite@sheffield.ac.uk.