Table 1 Representative clinical trials using stem cells for the treatment of liver fibrosis or cirrhosis
From: Stem cells for treatment of liver fibrosis/cirrhosis: clinical progress and therapeutic potential
Disease | No. of patients | Cell type | Dose | Route | Results | NCT number |
|---|---|---|---|---|---|---|
Decompensated liver cirrhosis | 219 | Umbilical cord mesenchymal stem cells | 0.5 × 106 cells/kg | Infusion via intravenous (every 4 weeks, 3 cycles) | A significant decrease of ascites volume, increase of serum albumin level in patients and improvements in MELD score | NCT01220492 |
Alcoholic liver cirrhosis | 12 | Allogeneic bone marrow mesenchymal stem cells | 5 × 107 cells | Injection via hepatic artery at week 4, 8 | Improvement in histology and Child–Pugh score, a significant decrease of levels of transforming growth factor-β1, type I collagen and α-smooth muscle actin | NCT01741090 |
Liver cirrhosis | 6 | Autologous adipose-derived mesenchymal stem cells | 1 × 108 cells/ml | Intrahepatic injection | Improvement in liver function, METAVIR score, Child–Pugh score, MELD score | NCT02297867 |
Liver fibrosis/Cirrhosis/Liver disease | 50 | Menstrual blood derived mesenchymal stem cells | 1 × 106 cells/kg | Infusion via intravenous (twice per week, for 2 weeks) | Not available in liver function improvement, ascites, Child–Pugh score, MELD score, SF36-quality of life, and complications | NCT01483248 |
Liver cirrhosis | 9 | Liver mesenchymal stem cells | - | - | Not available in blood parameters in tubing loop model and fibrin formation in thrombodynamics | NCT03632148 |
Decompensated liver cirrhosis | 40 | Stem cells from human exfoliated deciduous teeth | 1 × 106 cells/kg | Infusion via peripheral vein at week 0, 4, 8, 12 | Not available in liver function, MELD score, Child–Pugh score, survival rate at half of one year, changes of life quality | NCT03957655 |
Liver cirrhosis/Liver failure | 30 | Hepatocyte-like stem cells | 3–5 × 107 cells | Injection via port vein | Decrease of volumes of ascites and prothrombin complex from international normalized ratio, increase of serum albumin, improvement in liver function, MELD score | NCT00420134 |
Liver cirrhosis | 25 | Fetal liver cells | 5–10 × 108 cells | Infusion via splenic artery | Improvements in follow-up Child–Pugh score and follow-up MELD score | NCT01013194 |
Liver cirrhosis | 100 | G-CSF | 5 μg/kg | Injection via subcutaneously (every 12 h for 5 consecutive days, 4 cycles at 3 monthly intervals) | Increase in survival rate at 12 months, quality of life, HSC mobilization, improvement in MELD score, Child–Pugh score | NCT03415698 |
Decompensated fibrosis | 27 | Bone marrow-derived mononuclear cells and CD133+ cells | 2–3 × 109 mononuclear cells and 5–15 × 106 CD133+ cells | Injection via port vein | A transient improvement in the MELD score was observed in CD133 + group and no difference in mononuclears group | NCT01120925 |
Alcoholic liver cirrhosis | 5 | Autologous CD34 + stem cells | 1 × 106–2 × 108 cells | Injection via the portal vein or hepatic artery | 3 of the 5 patients showed improvement in serum bilirubin and 4 of 5 in serum albumin | NCT00147043 |
Decompensated liver cirrhosis | 14 | Endothelial progenitor cells | 1 × 108 cells | Injection via hepatic artery | A significant improvement in MELD score and 5 of the 9 patients showed a decreased of hepatic venous pressure gradient | NCT01333228 |