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Table 1 Clinical trials in liver diseases

From: Clinical trials using mesenchymal stem cells in liver diseases and inflammatory bowel diseases

No. Start year Cell source Autologous/allogeneic Administration route Number of cells infused Etiology Number of patients Follow-up period Phase Study design ClinicalTrials.gov identifier Status Result References
1 2013 Bone marrow Autologous Peripheral vein Unknown LC 20 48 weeks Phase 1–2 Non-randomized, single group assignment, open label NCT01877759 Unknown   
2 2009 Bone marrow Autologous Hepatic artery 5 × 106 cells/patient, 2 times LC (alcohol) 11 24 weeks Phase 2 Non-randomized, single group assignment, open label NCT01741090 Unknown Histological improvement. Improvement in Child- Pugh score. Decrease in TGFβ1, collagen type I, and α-SMA  
3 2009 Bone marrow Autologous Peripheral vein 1.0 × 106/kg LC 25 24 weeks Unknown Non-randomized, single group assignment, open label NCT01499459 Unknown Improvement in Alb and MELD scores. 13
4 2014 Umbilical cord Allogeneic Peripheral vein 4.0 × 107/patient, 4 times LC 320 144 weeks Phase 1–2 Non-randomized, parallel assignment, open label NCT01573923 Unknown   
5 2016 Adipose tissue Autologous Portal vein or hepatic artery 1.0 × 106/kg via peripheral vein, 3 times or 3.0 × 106/kg via hepatic artery, 3 times LC (HCV) 5 48 weeks Phase 1–2 Non-randomized, single group assignment, open label NCT02705742 Recruiting   
6 2007 Bone marrow Autologous Peripheral or portal vein 30–50 × 106/patient LC 8 24 weeks Phase 1–2 Randomized, single group assignment, single blind NCT00420134 Completed Improvement in liver function and MELD scores. 14
7 2016 Bone marrow Allogeneic Peripheral vein 2.0 × 106/kg, 4 times ACLF 30 96 weeks Phase 1 Randomized, parallel assignment, double blind (subject, caregiver, investigator) NCT02857010 Recruiting   
8 2009 Umbilical cord Allogeneic Peripheral vein 5.0 × 105/kg, 3 times ACLF (HBV) 43 96 weeks Phase 1–2 Randomized, parallel assignment, double blind (subject, caregiver) NCT01218464 Unknown Improvement in liver function and MELD scores. 15
9 2011 Bone marrow Allogeneic Peripheral vein 2.0 × 105/kg, 4 times or 1.0 × 106/kg, 4 times or 5.0 × 106/kg, 4 times Liver failure (HBV) 120 48 weeks Phase 2 Randomized, parallel assignment, open label NCT01322906 Unknown   
10 2010 Umbilical cord Allogeneic Unknown Unknown LC 20 48 weeks Phase 1–2 Randomized, parallel assignment, open label NCT01342250 Completed   
11 2012 Bone marrow Allogeneic Hepatic artery Unknown LC (Alcohol) 40 96 weeks Phase 2 Randomized, parallel assignment, open label NCT01591200 Completed   
12 2012 Umbilical cord Allogeneic Peripheral vein 1.0 × 105/kg, 4 times Liver failure (HBV) 120 48 weeks Phase 1–2 Randomized, parallel assignment, open label NCT01724398 Unknown   
13 2016 Bone marrow Autologous Portal vein 2.0 × 106/kg LC 40 24 weeks Phase 1–2 Non-randomized, parallel assignment, open label NCT02943889 Not yet recruiting   
14 2009 Umbilical cord Allogeneic Portal vein or hepatic artery Unknown LC 200 48 weeks Phase 1–2 Randomized, parallel assignment, single blind (subject) NCT01233102 Suspended   
15 2009 Bone marrow Autologous Portal vein Unknown LC (HBV) 60 48 weeks Phase 2 Non-randomized, parallel assignment, open label NCT00993941 Unknown   
16 2010 Umbilical cord Allogeneic Hepatic artery Unknown LC 50 4 weeks Phase 1–2 Randomized, parallel assignment, open label NCT01224327 Unknown   
17 2013 Bone marrow Autologous Hepatic artery 1.0 × 106/kg LC 30 12 weeks Phase 3 Non-randomized, single group assignment, open label NCT01854125 Enrolling by invitation   
18 2012 Umbilical cord Allogeneic Hepatic artery 1.0 × 106/kg LC (HBV) 240 48 weeks Phase 1–2 Randomized, parallel assignment, open label NCT01728727 Unknown   
19 2013 Umbilical cord or bone marrow Allogeneic Peripheral vein 1.0 × 105/kg, 1.0 × 106/kg or 1.0 × 107/kg, 8 times Liver failure (HBV) 210 72 weeks Phase 1–2 Randomized, parallel assignment, open label NCT01844063 Recruiting   
20 2016 Umbilical cord Allogeneic Peripheral vein 4 or 8 times ACLF (HBV) 261 52 weeks Phase 2 Randomized, parallel assignment, open label NCT02812121 Not yet recruiting   
21 2010 Menstrual blood Allogeneic Peripheral vein 1.0 × 106/kg, 4 times LC 50 48 weeks Phase 1–2 Randomized, single group assignment, open label NCT01483248 Enrolling by invitation   
22 2008 Bone marrow Autologous Hepatic artery Unknown LC 50 96 weeks Phase 2 Randomized, parallel assignment, single blind (subject) NCT00976287 Unknown   
23 2012 Bone marrow Autologous Hepatic artery 5 × 107/patient, 1 time or 2 times LC (alcohol) 72 24 weeks Phase 2 Randomized, parallel assignment, open label NCT01875081 Completed Histological improvement. Improvement in AST, ALT, ALP, γ-GTP, Child-Pugh score, and MELD score. 16
24 2014 Bone marrow Autologous Peripheral vein Unknown LC 10 24 weeks Phase 1 Non-randomized, single group assignment, open label NCT02327832 Recruiting   
25 2005 Bone marrow Autologous Hepatic artery 3.4 × 108/patient Liver failure (HBV) 158 192 weeks Phase 1–2 Case control, retrospective NCT00956891 Completed Improvement in Alb, T-Bil, PT, and MELD score.  
26 2009 Umbilical cord Allogeneic Peripheral vein 5.0 × 105/kg, 3 times LC 45 48 weeks Phase 1–2 Randomized, parallel assignment, open label NCT01220492 Unknown Improvement in Alb, T-Bil, and MELD score. Reduction of ascites. 17
27 2010 Bone marrow Autologous Portal vein 1.4–2.5 × 108/patient, 2 times LC 2 48 weeks Phase 1 Non-randomized, single group assignment, open label NCT01454336 Completed Transient improvement in MELD scores. 18
28 2007 Bone marrow Autologous Peripheral vein (1.2–2.95 × 108) 1.95 × 108/patient LC 27 48 weeks Unknown Randomized, parallel assignment, double blind (subject, outcomes assessor) NCT00476060 Unknown No beneficial effect. 19
29 2011 Bone marrow Allogeneic Hepatic artery and peripheral artery 1.0 × 106/kg (5.0 × 107 cells via the hepatic artery and the remaining cells via the peripheral vein) Wilson’s disease 10 24 weeks Unknown Non-randomized, single group assignment, open label NCT01378182 Completed   
30 2016 Umbilical cord or bone marrow Allogeneic Portal vein or hepatic artery 2.0 × 107/patient, 4 times LC 20 48 weeks Phase 1 Non-randomized, single group assignment, open label NCT02652351 Recruiting   
31 2016 Bone marrow Autologous Hepatic artery 5 × 107/patient, 1 time or 2 times LC (alcohol) 50 144 weeks Phase 2 Randomized, parallel assignment, open label NCT02806011 Enrolling by invitation   
32 2011 Umbilical cord Allogeneic Peripheral vein 1.0 × 106/kg, 3 times Liver failure (AIH) 100 96 weeks Phase 1–2 Randomized, parallel assignment, open label NCT01661842 Unknown   
33 2009 Adipose tissue Autologous Unknown Unknown LC 6 24 weeks Phase 1 Non-randomized, single group assignment, open label NCT00913289 Terminated   
34 2012 Adipose tissue Autologous Hepatic artery Unknown LC 4 4 weeks Unknown Non-randomized, single group assignment, open label NCT01062750 Completed   
35 2016 Umbilical cord Allogeneic Lobe 5.0 × 108/patient LC 40 96 weeks Phase 1–2 Randomized, parallel assignment, double blind (subject, outcomes assessor) NCT02786017 Recruiting   
36 2011 Bone marrow Unknown Peripheral vein 5.0–50 × 106/kg LC (PBC) 20 96 weeks Phase 1 Randomized, parallel assignment, open label NCT01440309 Unknown   
37 2011 Umbilical cord Allogeneic Peripheral vein 5.0 × 105/kg, 3 times LC (PBC) 7 48 weeks Phase 1–2 Randomized, parallel assignment, open label NCT01662973 Unknown Improvement in Alb, T-Bil, and MELD score. Reduction of ascites. 20
38 2010 Bone marrow Allogeneic Portal vein or hepatic artery Unknown Liver failure (HBV) 60 48 weeks Phase 2 Non-randomized, parallel assignment, open label NCT01221454 Unknown   
39 2010 Bone marrow Allogeneic Portal vein or hepatic artery Unknown LC 60 48 weeks Phase 2 Non-randomized, parallel assignment, open label NCT01223664 Unknown   
40 2010 Bone marrow Autologous Hepatic artery (0.25–1.25 × 106) 0.75 × 106/patient LC (HBV) 39 24 weeks Phase 2–3 Non-randomized, parallel assignment, open label NCT01560845 Unknown Decrease in Th-17 cells, RORγt, IL-17, TNF-α, and IL-6. Increase in Tregs and Foxp3. 21
  1. LC liver cirrhosis, ACLF acute-on-chronic liver failure, HBV hepatitis B virus, HCV hepatitis C virus, AIH autoimmune hepatitis, PBC primary biliary cholangitis, MELD Model for End-Stage Liver Disease, AST aspartate transaminase, ALT alanine transaminase, ALP alkaline phosphatase, γ-GTP gamma-glutamyl transpeptidase, Alb albumin, T-bill total bilirubin, PT prothrombin time, PC protein C, ROR RAR-related orphan receptor, Foxp3 forkhead box P3, IL interleukin, Th T helper, SMA smooth muscle actin, TGF transforming growth factor, TNF tumor necrosis factor