ISRCTN17160440.

Study name	A randomised controlled trial to assess the safety and effectiveness of stem cell transplantation using a reduced intensity regimen in patients with treatment resistant Crohn’s disease (ASTIClite)
Methods	Randomised controlled trial, phase III
Participants	Patients aged 18‐60years  who have refractory Crohn's disease
Interventions	Stem cell mobilisation with low dose cyclophosphamide 1g/m2 and G‐CSF followed by autologous transplantation with a reduced intensity (‘HSCTlite’) conditioning regimen (fludarabine 125mg/m2, cyclophosphamide 120mg/kg and rabbit‐ATG 7.5mg/kg) is safe and effective in inducing regression of ileo‐colonic ulceration in patients with refractory CD compared with standard care (control group).
Outcomes	Primary outcome: regression of mucosal ulceration is assessed using the SES‐CD ulcer sub score on colonoscopy at week 48.
Starting date	date applied 23/10/2017
Contact information	Miss Lizzie Swaby: United Kingdom +44 114 222 4023 e.a.swaby@sheffield.ac.uk Prof James Lindsay: United Kingdom +44 20 3954 3300 James.lindsay@bartshealth.nhs.uk
Notes	Sponsor information Organisation: Barts Health NHS Trust Sponsor details: The Royal London Hospital, Whitechapel, London, E1 1BB, United Kingdom