Table 3.

Key clinical studies in liver disease

	Study Design	Number of Patients Treated	Etiology of Liver Failure	Type of MSC	Route of Administration	Cell Numbers	Predefined Primary Endpoint	Outcome
Acute on Chronic Liver Failure
Shi et al., Stem Cells Translational Medicine, 2012	Open labeled nonrandomized controlled trial	24	Hepatitis B infection	UC MSC	Peripheral intravenous infusion	0.5 × 106·kg−3· wk−1 at 4-wk intervals for 3 cycles	No	Improved survival at 72 wk (20.8% vs. 47.4% P = 0.015)
Peng et al., Hepatology, 2011	Nonrandomized controlled trial	57	Hepatitis B infection	Autologous BM MSC	Hepatic artery infusion	3.8 × 108 by single injection	No	Improvement in MELD score at 36 wk (15.55 vs. 18.79)
Fibrosis/Cirrhosis
Zhang et al., Journal of Gastroenterology and Hepatology, 2012	Open labeled nonrandomized controlled trial	30	Chronic Hepatitis B infection	UC MSC	Peripheral intravenous infusion	0.5 × 106/kg every 4 wk on 3 occasions	No	Improvement in ascites volume assessed by ultrasound (5 mm vs. 22 mm at 50 wk) and albumin levels (32 vs. 35 P < 0.05)
Salama et al., Stem Cell Res Therapeutics, 2014	Randomized controlled trial	20	Hepatitis C infection	Autologous BM MSC	Peripheral intravenous infusion	1.0 × 106/kg by single infusion	No	Global improvement in liver function tests ≤6 mo (bilirubin 2.06 vs. 4.24, INR 1.52 vs. 1.84, ALT fold 1.27 vs. 1.09)
Mohamadnejad et al., Liver International, 2013	Randomized controlled trial	15	Mixed	Autologous BM MSC	Peripheral intravenous infusion	1.20–2.95 × 108 by single infusion	No	3 deaths in MSC treated group. No significant difference in MELD score or liver function tests
Xu et al., Journal of Gastroenterology and Hepatology, 2014	Randomized controlled trial	20	Hepatitis B infection	Autologous BM MSC	Hepatic artery infusion	8.45 × 108 by single infusion	No	Improvement in MELD score (11 vs. 9) and ALT (30 vs. 25) at 24 wk

MSC, mesenchymal stem cells; UC, umbilical cord; BM, bone marrrow; MELD, Model for End-Stage Liver Disease; ALT, alanine aminotransferase.