Table 1.
Clinical Trials using MSCs and LPCs in Liver Diseases.
| Title | NCT Number | Year | Country | Status | Cell Source | Disease | Outcome | Bibliography |
|---|---|---|---|---|---|---|---|---|
| Efficacy of Invitro Expanded BM Derived Allogeneic MSC Transplantation via Portal Vein or Hepatic Artery or Peripheral Vein in Patients With Wilson Cirrhosis | NCT01378182 | 2014 | Turkey | completed | BM-MSCs | WD | (NS) | (NI) |
| Dose Finding Study to Assess Safety and Efficacy of Stem Cells in LC | NCT01591200 | 2016 | India | completed | BM-MSCs | LC | Reasonably safe dose of up to 2.5 million cells/kg body weight | [63] |
| REVIVE (Randomized Exploratory Clinical Trial to Evaluate the Safety and Effectiveness of Stem Cell Product in Alcoholic LC Patient) | NCT01875081 | 2016 | Korea | completed | BM-MSCs | LC | Reduction of collagen deposition | [64] |
| The Effectiveness and Safety for MSCs for Alcoholic LC | NCT01741090 | 2012 | Korea | unknown | BM-MSCs | LC | Improved histology, Child Pugh’s Score | [65] |
| Study to Evaluate Hepatic Artery Injection of Autologous hBM-MSCs in Patients With Alcoholic LC | NCT03838250 | 2020 | United States | recruiting | BM-MSCs | LC | (NS) | (NI) |
| Clinical Trial to Evaluate the Efficacy and Safety of Cellgram-LC Administration in Patients With Alcoholic Cirrhosis (Cellgram-LC) | NCT04689152 | 2021 | Korea | recruiting | BM-MSCs | LC | (NS) | (NI) |
| BM-MSC Transplantation in LC Via Portal Vein | NCT00993941 | 2010 | China | active, not recruiting | BM-MSCs | LC | (NS) | (NI) |
| Autologous MSC Transplantation in LC | NCT01499459 | 2012 | Turkey | active, not recruiting | BM-MSCs | LC | Improvement in Alb and MELD scores | [66] |
| MSC Transplantation in Decompensated Cirrhosis | NCT00476060 | 2011 | Iran | active, not recruiting | BM-MSCs | LC | No beneficial effect. | [67] |
| Transplantation of Autologous MSCs in Decompensate Cirrhotic Patients With Pioglitazone | NCT01454336 | 2014 | Iran | completed | BM-MSCs | LC | (NS) | (NI) |
| Therapeutic Effects of Liver Failure Patients Caused by Chronic Hepatitis B After Autologous MSC Transplantation | NCT00956891 | 2010 | China | completed | BM-MSCs | HBV-related LF | No markedly improved long-term outcomes | [68] |
| Safety and Efficacy of Human BM-MSCs for Treatment of HBV-related Liver Cirrhosis | NCT01724697 | 2012 | China | unknown | BM-MSCs | LC | (NS) | (NI) |
| Trial of MSC Transplantation in Decompensated LC | NCT03209986 | 2018 | China | unknown | MSCs | LC | (NS) | (NI) |
| Human UC-MSC Transplantation for Patients With Decompensated Liver Cirrhosis | NCT01342250 | 2011 | China | completed | UC-MSCs | LC | (NS) | (NI) |
| UC-MSCs for Patients With Liver Cirrhosis | NCT01220492 | 2018 | China | completed | UC-MSCs | LC | Improved liver function | [69] |
| UC-MSCs for Decompensated Cirrhosis (MSC-DLC-1) | NCT05227846 | 2022 | China | not yet recruiting | UC-MSCs | LC | (NS) | (NI) |
| MSC treatment for Decompensated LC | NCT03945487 | 2019 | China | recruiting | UC-MSCs | LC | (NS) | (NI) |
| Treatment with UC-MSCs for Decompensated Cirrhosis | NCT05121870 | 2021 | China | recruiting | UC-MSCs | LC | (NS) | (NI) |
| UC-MSCs for Decompensated Cirrhosis (MSC-DLC-2) | NCT05224960 | 2022 | China | not yet recruiting | UC-MSCs | LC | (NS) | (NI) |
| UC -MSC Transplantation for Children Suffering From Biliary Atresia (UCMSCBA) | NCT04522869 | 2020 | Vietnam | recruiting | UC-MSCs | LC | (NS) | (NI) |
| Study of Decompensated Alcoholic Cirrhosis Treatment by Stem Cells | NCT05155657 | 2022 | China | recruiting | UC-MSCs | LC | (NS) | (NI) |
| UC-MSC Transplantation Combined With Plasma Exchange for Patients With Liver Failure | NCT01724398 | 2013 | China | unknown | UC-MSCs combined with PE | HBV-related LF | Decreased levels of total bilirubin, alanine aminotransferase, aspartate transaminase and MELD score |
[70] |
| Safety and Efficacy of UC-MSCs for Treatment of HBV-related Liver Cirrhosis | NCT01728727 | 2013 | China | unknown | UC-MSCs | LC | (NS) | (NI) |
| Safety and Efficacy of hMSCs for Treatment of Liver Failure | NCT01218464 | 2013 | China | unknown | UC-MSCs | HBV-related LF | (NS) | (NI) |
| UC-MSCs for Patients With Primary Biliary Cirrhosis | NCT01662973 | 2013 | China | recruiting | UC-MSCs | PBC | 1. Improvement in Alb, T-BIL and MELD score. 2. Decrease in serum alkaline phosphate andg-glutamilitransferase levels. |
[71] |
| Safety of UC-MSC Transfusion for ACLF Patients | NCT04822922 | 2021 | China | not yet recruiting | hUC-MSCs | ACLF | (NS) | (NI) |
| UC-MSCs (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosishepatitis b Cirrhosis | NCT03826433 | 2022 | China | recruiting | UC-MSCs | LC | (NS) | (NI) |
| UC-MSC Transplantation for Decompensated Hepatitis B Cirrhosis | NCT05106972 | 2021 | China | recruiting | UC-MSCs | LC | (NS) | (NI) |
| Combination of Autologous MSC and HSC Infusion in Patients with Decompensated Cirrhosis | NCT04243681 | 2020 | India | completed | HPCs (CD34+) combined with MSCs | LC | Improvement in the MELD score and in serum albumin levels |
[72] |
| A Clinical Study to Evaluate the Safety and Efficacy of MSCs in Liver Cirrhosis | NCT01877759 | 2013 | India | unknown | BM-MSCs and UC-MSCs | LC | (NS) | (NI) |
| Safety and Efficacy of Diverse MSCs Transplantation for Liver Failure | NCT01844063 | 2013 | China | unknown | BM-MSCs and UC-MSCs | HBV-related LF | (NS) | (NI) |
| Liver Regeneration Therapy by Intrahepatic Arterial Administration of Autologous Adipose Tissue Derived Stromal Cells | NCT01062750 | 2015 | Japan | completed | AD-MSCs | LC | (NS) | (NI) |
| Clinical Trial Study About Human Adipose-Derived Stem Cells in the LC | NCT02297867 | 2018 | Taiwan | completed | AD-SCs | LC | Repaired liver fibrosis | [73] |
| A Study of ADR-001 in Patients With LC | NCT03254758 | 2021 | Japan | recruiting | AD-MSCs | LC | (NS) | (NI) |
| Improvement of Liver Function in LC Patients After Autologous MSC Injection: Phase I-II Clinical Trial | NCT00420134 | 2009 | Iran | completed | MSC-derived HLCs | LC | Improved liver function | [74] |
| Stem Cell Transplantation in Cirrhotic Patients | NCT02943889 | 2016 | Egypt | unknown | MSC-derived HLCs | LC | (NS) | (NI) |
| Human Fetal Liver Cell Transplantation for Treatment of Chronic Liver Failure | NCT01013194 | 2015 | Italy | completed | LPCs | LC | (NS) | [75] |
(NS) Non-Specified, (NI) Non-Identified. BM-MSCs: Bone Marrow MSCs; UC-MSCs: Umbilical cord MSCs; AD-MSCs: Adipose Tissue MSCs; HLCs: Hepatocyte-Like Cells; HPCs: Hematopoietic Progenitor Cells; LPCs: human Liver Progenitor Cells; T-BIL: PE, Total Bilirubin; PE: Plasma Exchange; WD: Wilson’s Disease; LC: Liver Cirrhosis; LF: Liver Failure; PBC: Primary Biliary Cirrhosis; ACLF: Acute-on-Chronic Liver Failure.