Table 2 Clinical trials using MSCs to treat liver disease
From: Mesenchymal stem cell therapy for liver disease: full of chances and challenges
Liver diseases | Type of clinical trials | No. of patient treated | No. of control patient | Source of MSCs | Route | Dose | Relevant indicators and patient response | Refs |
|---|---|---|---|---|---|---|---|---|
Decompensated liver cirrhosis | No control group | 4 | 0 | Autologous, bone marrow | Peripheral vein | 3 × 107 | Slightly improvement of liver function tests and MELD scores in two of four patients | Mohamadnejad et al. [113] |
Liver cirrhosis | No control group | 8 | 0 | Autologous, iliac crest | Peripheral or the portal vein | 3–5 × 107 | Improvement of liver function and MELD scores | Kharaziha et al. [9] |
Liver failure caused by hepatitis B | Randomized Controlled trial | 53 | 105 | Autologous, bone marrow | Hepatic artery | None | Short-term efficacy was favorable, but long-term outcomes were not markedly improved | Peng et al. [14] |
Liver failure caused by hepatitis C | Randomized controlled trial | 20 | 20 | Autologous, bone marrow-derived hepatocyte | Intrahepatic, intrasplenic | 2 × 107 hepatic lineage committed cells | Significant improvement in Child score, MELD, fatigue scale, and performance status | Amer et al. [17] |
Primary biliary cirrhosis | Non-control | 7 | 0 | Allogenic, umbilical cord | Peripheral vein | 0.5 × 106 cells/kg body | Decrease in serum alkaline phosphatase and g-glutamyltransferase levels | Wang et al. [12] |
Acute-on-chronic liver failure | Parallel-controlled trial | 24 | 19 | Allogenic, umbilical cord | Cubital vein of the arm | 0.5 × 106 cells/kg body | Improvement of the survival rates, MELD and liver function | Shi et al. [15] |
Decompensated liver cirrhosis | Paired, controlled study | 30 | 15 | Allogenic, umbilical cord | Intravenously | 0.5 × 106 cells/kg body | Improvement of liver function and reduction in the volume of ascites | Zhang et al. [4] |
Liver cirrhosis caused by hepatitis C | Randomized controlled trial | 15 | 10 | Autologous, bone marrow | Intravenously | 1 × 106 cells/kg body | Improvement of liver function, and decline of elevated bilirubin and MELD score | Ansary et al. [5] |
Decompensated liver cirrhosis | Randomized controlled trial | 15 | 12 | Autologous, bone marrow | Peripheral vein | 2 × 108 | No improvement of Child scores, MELD scores, and liver function | Mohamadnejad et al. [8] |
Liver cirrhosis caused by hepatitis C | No control group | 20 | 0 | Autologous, bone marrow | Intrasplenic | 1 × 107 | Improvement of liver function | Sabry et al. [46] |
Alcoholic cirrhosis | No control group | 11 | 0 | Autologous, bone marrow | Hepatic artery | 5 × 107 | Improvement of Child–Pugh score,and decrease of TGFb1,a-SMA | Jang et al. [114] |
End-stage liver disease related with HCV | Randomized controlled trial | 20 | 20 | Autologous, bone marrow | Peripheral vein | None | 54% showed near normalization of liver enzymes and improvement in liver synthetic function | Salama et al. [18] |
Liver cirrhosis caused by hepatitis B | Randomized controlled trial | 20 | 19 | Autologous, bone marrow | Hepatic artery | None | Improvement of liver function and an increased Treg/ Th17 ratio | Xu et al. [6] |
Liver cirrhosis | No control group | 12 | 0 | Autologous, bone marrow | Peripheral vein | 1 × 106/kg | Partly improvement of MELD, no change in liver regeneration and fibrosis after 6 months | Kantarcıoğlu et al. [115] |
Alcoholic cirrhosis | Randomized controlled trial | 37 | 18 | Autologous, bone marrow | Hepatic arterial | 5 × 107, one-time or two-time | Improvement of liver function and Child–Pugh scores | Suk et al. [10] |
Acute Liver Allograft Rejection | Randomized controlled trial | 14 | 13 | Allogenic, umbilical cord | Intravenously | 1 × 106/kg body | Improvement of liver function and allograft histology, increased Treg/ Th17 ratio, CD4 T-cell activation; elevated Levels of TGF-b1 and PGE2 | Shi et al. [19] |
Acute-on-chronic liver failure | Randomized controlled trial | 56 | 54 | Allogenic, bone marrow | Intravenously | 1.0 to 10 × 105 cells/kg | Improvement of survival rate, liver function, reduction of infection | Lin et al. [16] |
Liver cirrhosis caused by autoimmune disease | No control group | 26 | 0 | Allogenic, umbilical cord, umbilical cord blood, bone marrow | Intravenously | 1 × 106/kg | Improvement of liver function and MELD scores | Liang et al. [11] |
Liver transplantation | Non-randomized, controlled trial | 10 | 10 | Allogenic, bone marrow | Intravenously | 1.5–3 × 106 /kg | Not sufficient to allow withdrawal of immunosuppression | Detry et al. [20] |
Liver cirrhosis | No control group | 4 | 0 | Autologous, adipose | Hepatic artery | 6.6 × 105 cells/kg | Improvement of liver function, and HGF, IL-6 increased | Sakai et al. [116] |
Ischemic-type biliary lesions following liver transplantation | Randomized controlled trial | 12 | 70 | Allogenic, umbilical cord | Peripheral intravenous infusion | 1 × 106/kg, 6-time | Improvement of survival rate and liver function | Zhang et al. [117] |
Liver cirrhosis | Randomized controlled trial | 50 | 53 | Allogenic, umbilical cord | Intravenously | (4.0–4.5) × 108 | Improvement of Child scores, MELD scores, and liver function | Fang et al. [7] |