ASTIClite EBMT Follow-up
Research type
Research Study
Full title
Autologous Stem cell Transplantation In refractory Crohn’s disease – Low Intensity Therapy Evaluation (ASTIClite) – Long term follow up through the EBMT
IRAS ID
228818
Contact name
James Lindsay
Contact email
Sponsor organisation
Barts Health NHS Trust
Duration of Study in the UK
8 years, 7 months, 31 days
Research summary
Crohn's disease is a long term condition that causes inflammation of the lining of the digestive system. There is no cure at the moment, and current treatments only reduce symptoms, and often have intolerable side effects. In some patients, current treatments only provide temporary benefit, or fail to respond at all. An alternative therapy is haematopoetic stem cell transplantation (HSCT). This treatment is being assessed in the ASTIClite randomised controlled trial, and this study aims to assess the long term safety and efficacy of this procedure.
Participants recruited to the ASTIClite RCT will be invited to take part in the EBMT follow up study, and will sign a separate consent form. Data collected from the point of stem cell transplant (or equivalent day 0 in the control group) will be entered into the EBMT database, along with annual follow up data for at least four years after the end of the RCT. This data collection takes place in standard care for all patients undergoing transplantation, but this research will collect the data for all participants, regardless of whether they have had a transplant, or continued on usual care.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
17/NW/0669
Date of REC Opinion
4 Dec 2017
REC opinion
Further Information Favourable Opinion