Spahr 2013.

Study characteristics
Methods	Single‐centre, open‐label randomised controlled trial
Participants	Country: Switzerland Period of recruitment: from February 2008 to March 2011 Number randomised: 58 Postrandomisation dropouts: 1 Revised sample size: 57 Average age (years): 56 Males: 76% Decompensated cirrhosis: 100% Acute‐on‐chronic liver failure: 81% Alcohol‐related cirrhosis: 100% Viral‐related cirrhosis: 0% Autoimmune disease‐related cirrhosis: 0% Other causes of cirrhosis: 0% Inclusion criteria "Patients admitted to our hospital for decompensated ALD were considered eligible if they met the following criteria." Clinical decompensation manifested by ascites and/or jaundice in active drinkers (≥ 80 g/day of alcohol) A liver biopsy performed within 7 days of admission Aged 18 to 75 years MELD score < 26 Written informed consent to participate Exclusion criteria Pregnancy Hepatitis B, C, or HIV Documented hepatocellular carcinoma Biliary tract obstruction Liver biopsy showing causes other than ALD for decompensation Complete portal vein thrombosis Hypersensitivity to G‐CSF Severe coagulopathy (platelets < 50 G/l+INR > 1.5) Serum creatinine > 150 umol/L Any ongoing infection Recent (10 days) gastrointestinal bleed Estimated survival < 6 months Clinically overt hepatic encephalopathy
Interventions	Experimental "A 5‐day course of lenograstim (G‐CSF, Granocyte, SANOFI Aventis, Meyrin, Geneva) to mobilize bone marrow cells at a dose of 10 µg/kg per day subcutaneously + infusion of autologous bone marrow mononuclear cell into the proper hepatic artery through a 5F catheter under light sedation (propofol 20–50 mg IV), and standard medical treatment" Control Standard medical treatment alone All participants received standard medical therapy. Standard medical treatment included vitamin B supplements, stimulation of calorie intake, specialised support regarding alcohol abstinence but no pharmacological intervention, and a 4‐week course of prednisone 40 mg/day in case of severe AH, as defined by a Maddrey’s score > 32).
Outcomes	Primary outcome Improved liver function at 90 days of follow‐up, as defined by a decrease in the MELD score of at least 3 points as compared to baseline value Secondary outcome Safety and evolution of parameters associated with liver regeneration and inflammation
Notes	Conflicts of interests: the authors declared that no competing interests exist. Funding: this study was financially supported by the Clinical Research Center, University Hospital and Faculty of Medicine, Geneva, and the Louis‐Jeantet Foundation, and FLAGS (Foundation for Liver and Gut Studies in Geneva), and la Loterie Romande. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Trial registration number: ISRCTN83972743
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Allocation to each treatment group was performed using a computer generated randomization code inserted in sequentially numbered opaque envelopes."
Allocation concealment (selection bias)	Low risk	"Allocation to each treatment group was performed using a computer generated randomization code inserted in sequentially numbered opaque envelopes."
Blinding of participants and personnel (performance bias) All outcomes	High risk	This was an open‐label study.
Blinding of outcome assessment (detection bias) overall mortality	Low risk	No information was given, but for the mortality outcome, low risk of bias.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No information was given.
Incomplete outcome data (attrition bias) All outcomes	Low risk	One participant (1/58) was lost at follow‐up.
Selective reporting (reporting bias)	Low risk	The trial reported the outcome all‐cause mortality.
Other bias	Low risk	We found no other bias.