Review Article

Current Perspectives Regarding Stem Cell-Based Therapy for Liver Cirrhosis

Table 1

Main clinical trials of stem cell therapy for liver cirrhosis.

Trial numberStudy phase (type)Cell source#Eligibility criteriaPrimary outcome measureSecondary outcome measureTime frameStart dateEnd dateLocation

NCT01875081Phase II (randomized open)BM-MSC72Histologically or clinically diagnosed as alcoholic liver cirrhosis 
Classified as Child-Pugh grade B or C
Histopathological evaluationHistopathological evaluation score, MELD score, Child-Pugh grade, and so on6 months2012.112016.03 (completed)Korea

NCT02943889Phase I/II (nonrandomized open)BM-MSC40Decompensated liver cirrhosis Child class b or cImprovement of liver function in form of improvement in Child scorePostpone or overcome liver transplantation complications6, 24 months2016.102017.08 (not yet recruiting)None

NCT02786017Phase I/II (randomized double-blinded controlled)UC-MSC40Subjects who are decompensated cirrhosis of any cause 
Child-pugh score ≥7
Change in the model for end-stage liver disease (MELD) scoreChange in Child-Pugh score, clinical laboratory parameters of liver function1 and 3 days 
1 and 2 weeks 
1, 3, 6, 12, and 24 months
2016.052018.12 (recruiting)China

NCT01591200Phase II (randomized open)AlloMSC40Child class B or C, Child-Pugh scores of ≥7 and <14 
MELD scores of at least 10
SafetyLiver function improvement, Child-Pugh score, MELD score, SF36-QOL, and so on24 months2012.062016.04 (completed)India

NCT01120925Phase I/II 
(randomized quadruple blind controlled)
BM-MSC30MELD score of 12 or Child score B or C 
Serum ALT 1/5 times more than normal
Liver function testCirrhosis mortality6 months2010.052013.07 (completed)Iran

NCT00420134Phase I/II 
(randomized single- 
blinded)
MSC30MELD score of at least 10 
Patent portal vein on color Doppler examination of the live 
Normal alpha-feto protein serum levels
Liver function test 
MELD score
Cirrhosis mortality6 months2006.022009.06 (completed)Iran

NCT01013194Phase I/II (nonrandomized open)FLC25A score ≥ B8 based on the Child-Pugh-Turcotte classification and/or MELD score ≥ 14Survival Analysis of Child-Pugh score, meld score from baseline to 1-year follow-up6 and 12 months2007.022011.07 (completed)Italy

NCT01342250Phase I/II (randomized open)UC-MSC20Decompensated liver cirrhosis, Child-Pugh B/C (7–12 points) or Meld score ≦ 21.Survival Liver function improvement, Child-Pugh score, MELD score, SF36-QOL, and so on24 months2010.102011.10 (completed)China

NCT02652351Phase I (open)UC-MSC20Clinical, radiological, or biochemical evidence of liver cirrhosisSeverity of adverse eventsHepatic function, liver fibrosis index1, 3, 6, and 12 months2016.032016.10 (recruiting)China

NCT01147380Phase I (nonrandomized open)NK18Subjects who need to meet the liver transplant eligibility criteria 
Cardiac and pulmonary function
Side effect of cadaveric donor liver NK cell infusionNK cell infusion-related toxicity, anti-HCC, HCV effect12 and 24 months2010.062014.12 (completed)USA

NCT03254758Phase I/II (open)AD-MSC15Chronic hepatitis C or nonalcoholic steatohepatitis (NASH) 
Child-Pugh grade B liver cirrhosis
Child-Pugh score, safety profileChild-Pugh score, safety profile6 months2017.072018.12 (recruiting)Japan

NCT01333228Phase I/II (open)BM-EPC14Liver cirrhosis (Child-Pugh 8 or above)Safety and tolerabilityEffect on liver function, portal hypertension, complications of liver cirrhosis12 months2012.062015.03 (completed)Spain

NCT01503749Phase I (randomized 
open)
PB-MNC (G-CSF)9Advanced liver cirrhosis with Child-Pugh score 8 or 9Severe adverse eventsChange in Child-Pugh score and MELD score1–4 weeks 
2–6 months
2012.012014.08 (completed)-

NCT00713934Phase I/II (randomized single- 
blinded)
BMMNC 
BMHSC
7Liver biopsy showing histological cirrhosis, grade B or C (Child-Pugh score) liver cirrhosis in sonography study 
Liver crrhosis in sonography study
Liver function test 
MELD score
Cirrhosis mortality6 months2008.012009.02 (completed)Iran

NCT02297867Phase I (open)ADSC6Investigators without HBV, HCV, HIV, syphilis, and so onMELDNone1–6 months2015.072018.01 (active, not recruiting)Taiwan

NCT02705742Phase I/II (open)AD-MSC5Clinical, radiologic, and pathologically proven liver cirrhosis due to HCV hepatitisAll cause mortality-12 months2016.012017.12 (recruiting)Turkey

NCT01454336Phase I (open)BM-MSC3Approved cirrhosis by elastography, biopsy, sonographyALT, AST, serum albumin, liver fibrosisProgression of fibrosis12 months2010.062013.07 (completed)Iran

of enrollments; MELD, model for end-stage liver disease; UC-MSC, umbilical cord mesenchymal stem cell; AlloMSC, allogeneic MSC; FLC, fetal liver cell; BM-EPC, bone marrow-derived endothelial progenitor cells; PB-MNC, peripheral blood mononucleated cells; BMHSC, bone marrow CD133+ hematopoietic stem cell.