Table 1.
Summary of clinical trials using mesenchymal stem cells for the treatment of liver fibrosis.
| ClinicalTrials.gov identifier | Country | Conditions | Phase | Estimated enrollment | Allocation/masking | Intervention model | Biological | Auto/Allo | Cell number | Cell injection times | Cell injection route |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02705742 | Turkey | HCV-related liver cirrhosis | I/II | 5 participants | N/A/open label | Single group assignment | AT-MSC | Auto | 1 × 106/kg | N/A | Hepatic artery and peripheral vein |
| NCT02652351 | China | Liver cirrhosis | I | 20 participants | N/A/open label | Single group assignment | UC-MSC | Allo | A single dose of 2 × 107 | 4 | Intravenous or hepatic artery |
| NCT02786017 | China | Decompensated cirrhosis | I/II | 40 participants | Randomized/double (participant, outcome assessor) | Parallel assignment | Injectable Collagen scaffold + HUC-MSCs | Allo | The total amount was 5 × 108 | N/A | peripheral vein |
| NCT03209986 | China | HBV/HCV-related liver cirrhosis | N/A | 200 participants | Randomized/single (outcomes assessor) | Parallel assignment | MSC | N/A | 1 × 106/kg | 3 | Peripheral vein |
| NCT03668145 | China | Primary biliary cirrhosis | N/A | 140 participants | Randomized/quadruple (participant, care provider, investigator, outcome assessor) | Parallel assignment | MSC | N/A | 0.1 − 1 × 106/kg | 3 | Peripheral vein |
| NCT03529136 | China | Decompensated cirrhosis | II | 252 participants | Nonrandomized/open label | Parallel assignment | UC-MSC | Allo | 1.5 × 106/kg | 2~4 | Peripheral vein |
| NCT03626090 | Singapore | Liver cirrhosis | I/II | 20 participants | N/A/open label | Single-group assignment | BM-MSC | Auto | 0.5 − 1 × 106/kg | N/A | Peripheral vein |
| NCT03826433 | China | Decompensated hepatitis b cirrhosis | I | 20 participants | Nonrandomized/open label | Parallel assignment | UC-MSC | Allo | 6 × 107/30 ml | N/A | Peripheral vein |
| NCT03945487 | China | Decompensated cirrhosis | II | 200 participants | Randomized/open label | Parallel assignment | UC-MSC | Allo | 1.0 × 106/kg | 3 | Intravenous |
| NCT03838250 | United States | Alcoholic liver cirrhosis | I | 10 participants | N/A/open label | Single-group assignment | Cellgram™ (BM-MSC) | Auto | 5 × 107/10 ml | N/A | Hepatic artery |
| NCT04243681 | India | Decompensated cirrhosis | IV | 5 participants | Nonrandomized/open label | Parallel assignment | CD 34 and MSC | Auto | N/A | N/A | Hepatic artery |
| NCT03460795 | China | Decompensated cirrhosis | I/II | 30 participants | N/A/open label | Single-group assignment | MSCs and Tregs | N/A | N/A | N/A | N/A |
| NCT01454336 | Iran | Liver fibrosis/decompensated cirrhosis | I | 3 participants | N/A/open label | Single-group assignment | MSC | Auto | N/A | N/A | N/A |
| NCT01220492 | China | Liver fibrosis | I/II | 266 participants | Randomized/open label | Parallel assignment | UC-MSC | N/A | N/A | N/A | N/A |
| NCT01342250 | China | Decompensated cirrhosis | I/II | 20 participants | Randomized/open label | Parallel assignment | UC-MSC | N/A | N/A | N/A | N/A |
| NCT01499459 | Turkey | Liver cirrhosis | N/A | 25 participants | N/A/open label | Single-group assignment | MSC | Auto | N/A | N/A | N/A |
| NCT01233102 | China | Liver cirrhosis | I/II | 200 participants | Randomized/single (single (participant)) | Parallel assignment | MSC | N/A | N/A | N/A | Hepatic artery or vein |
| NCT01741090 | Republic of Korea | Alcoholic liver cirrhosis | II | 12 participants | N/A/open label | Single-group assignment | MSC | N/A | N/A | N/A | N/A |
| NCT00976287 | China | Liver cirrhosis | II | 50 participants | Randomized/single (single (participant)) | Parallel assignment | BM-MSC | Auto | N/A | N/A | Hepatic artery |
| NCT00993941 | China | Liver cirrhosis | II | 60 participants | Nonrandomized/open label | Parallel assignment | BM-MSC | N/A | N/A | N/A | N/A |
| NCT01728727 | China | HBV-related liver cirrhosis | I/II | 240 participants | Randomized/open label | Parallel assignment | UC-MSC | N/A | N/A | N/A | N/A |
| NCT01483248 | China | Liver fibrosis/liver cirrhosis | I/II | 50 participants | Randomized/open label | Single-group assignment | hMB-MSC | N/A | N/A | N/A | N/A |
| NCT03254758 | Japan | Decompensated cirrhosis | I/II | 15 participants | N/A/open label | Single-group assignment | MSC | N/A | N/A | N/A | N/A |
| NCT04357600 | Indonesia | Liver cirrhosis | I/II | 12 participants | N/A/open label | Single-group assignment | UC-MSC | N/A | N/A | N/A | N/A |
| NCT01573923 | China | Liver cirrhosis | I/II | 320 participants | Nonrandomized/open label | Parallel assignment | UC-MSC | N/A | N/A | N/A | N/A |
| NCT01224327 | China | Liver cirrhosis | I/II | 50 participants | Randomized/open label | Parallel assignment | UC-MSC | N/A | N/A | N/A | Hepatic artery |
| NCT04522869 | Vietnam | Primary Biliary cirrhosis | I/II | 34 participants | Nonrandomized/open label | Parallel assignment | UC-MSC | N/A | N/A | N/A | N/A |
| NCT01662973 | China | Primary biliary cirrhosis | I/II | 100 participants | Randomized/open label | Parallel assignment | UC-MSC | N/A | N/A | N/A | N/A |
| NCT02943889 | Egypt | Liver cirrhosis | I/II | 40 participants | Nonrandomized/open label | Parallel assignment | MSC | N/A | N/A | N/A | N/A |
| NCT00476060 | Iran | Decompensated cirrhosis | II | 36 participants | Randomized/double (participant, outcome assessor) | Parallel assignment | MSC | Auto | N/A | N/A | N/A |
| NCT01440309 | China | Primary biliary cirrhosis | I | 20 participants | Randomized/open label | Parallel assignment | MSC | Allo | N/A | N/A | N/A |