Hawkey 2015.

Study characteristics
Methods	Parallel‐group randomised clinical trial conducted in 11 European transplant units (6 European countries) from July 2007 to September 2011, with follow‐up through March 2013.
Participants	45 Patients  aged 18 to 50 years with impaired quality of life from refractory Crohn's disease not amenable to surgery despite treatment with 3 or more immunosuppressive or biologic agents and corticosteroids.
Interventions	45 patients underwent stem cell mobilisation before 1:1 randomisation. Intervention group: immuno‐ablation and autologous hematopoietic stem cell transplantation (HSCT) (n = 23) injected in through route. HSCT was extracted from the bone marrow of the patients. Dosage: Minimum 3x106 CD34+ cells/kg on day 7 Control group: (HSCT deferred for 1 year [n = 22]). All were given standard Crohn's disease treatment as needed.
Outcomes	Primary outcomes: sustained disease remission at 1 year, a composite primary end point comprising clinical remission (Crohn's disease Activity Index (CDAI) <150, no use of corticosteroids or immunosuppressive or biologic drugs for at least the last 3 months, and no endoscopic or radiological evidence of active (erosive) disease anywhere in the gastrointestinal (GI) tract. Secondary outcomes were individual components of the primary composite outcome and other measures of disease activity, laboratory results, quality of life and functional status, and GI tract imaging.
Notes	Trial start date: from July 2007 to September 2011 Trial ending date: with follow‐up through March 2013 Trial registry number: NCT00297193 (ASTIC trial) Funding Source: Sponsor: European Group for Blood and Marrow Transplantation. Collaborator: The Broad Foundation. Conflict of interest: all authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Hawkey reported receiving a National Institute for Health Research Senior Investigator Award and receiving funding from the University of Nottingham Medical School Dean’s Fund and the Nottingham University Hospitals NHS Trust Research and Development Fund. No other authors reported disclosures.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Randomization was centralized and used balanced non‐stratified (1:1) electronically generated random number tables in permuted blocks of 4 patients prepared by the Nottingham Clinical Trials Unit."
Allocation concealment (selection bias)	Low risk	"all parties, including the trial coordinator, were unaware of the randomization group until allocation"
Blinding of participants and personnel (performance bias) All outcomes	High risk	Because of the nature of the intervention, patients, clinicians, investigators, and coordinators were not blinded to treatment assignment.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"an adjudication committee that reviewed all radiology and endoscopy reports to determine the presence and activity of Crohn disease within the GI tract were blinded to time of assessment and treatment assignment."
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis was done. All participants reported the primary outcome (CDAI at 24 weeks and clinical remission). Eight patients in the placebo group withdrew due to disease flare which required either surgical intervention or early transplant. and one patient after the randomization, thus the long‐term effect on CDAI couldn't be assessed and was measured by the "Worst‐case scenario" implementation.
Selective reporting (reporting bias)	Low risk	Primary outcome in protocol matches the one in the study. Note: Some secondary outcomes mentioned in protocol were not assessed in the study
Other bias	Low risk	No difference in baseline characteristics