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Table 1 Clinical trials of MSCs therapy in liver diseases

From: Mesenchymal stromal/stem cells and their extracellular vesicles in liver diseases: insights on their immunomodulatory roles and clinical applications

Condition or disease

Design

Study phase

Source of MSCs

Injection route

Main outcome measures

Date (completed)

NCT number

Liver failure, cirrhosis

Randomized, single group assignment

Phase 1

Phase 2

Autologous MSC

Portal vein

Liver function, MELD score, cirrhosis mortality

2009

NCT00420134

Liver failure

Case–control

–

Autologous BM-MSC

Hepatic artery

ALT, ALB, TB, PT, MELD score, incidence of HCC

2010

NCT00956891

Liver cirrhosis

Randomized

Parallel assignment

Phase 1

Phase 2

Allogeneic UC-MSC

–

OS, liver function, incidence of HCC, Child–Pugh score, MELD score, SF36-QOL

2011

NCT01342250

Liver fibrosis

N/A, single group assignment

Phase 1

Autologous BM-MSC

Portal vein

ALT, AST, ALB, fibrosis progression

2013

NCT01454336

Wilson’s Disease

N/A, single group assignment

N/A

Allogeneic BM-MSC

Portal vein

Hepatic artery

Liver biopsies

2014

NCT01378182

Liver cirrhosis

N/A, single group assignment

N/A

Autologous AD-MSC

Inter-hepatic

Harmful events

2015

NCT01062750

Liver cirrhosis

Randomized

Parallel assignment

Phase 1

Phase 2

Autologous BM-MSC

Allogeneic UC-MSC

Peripheral vein

Survival time, incidence of HCC events, ALT, TB, PT, ALB, PA, complications

2016

NCT01220492

Alcoholic liver cirrhosis

Randomized

Parallel assignment

Phase 2

Allogeneic BM-MSC

Hepatic artery

Safety, liver function, MELD score, histopathology, SF36-QOL, Child–Pugh score

2016

NCT01591200

Alcoholic liver cirrhosis

Randomized

Parallel assignment

Phase 2

Autologous BM-MSC

Hepatic artery

Histopathological evaluation, MELD score, Child–Pugh score, liver function (ALT, AST, ALP, ALB, bilirubin, GGT), visual inspection (liver volume, fibroscan)

2016

NCT01875081

Liver failure

Non-randomized

Parallel assignment

Phase 1

Phase 2

Allogeneic BM-MSC

Peripheral vein

Safety, tolerability, bilirubin, INR, transaminases, GGT, Biopsy-proven rejection rates, immune function

2019

NCT01429038

Decompensated cirrhosis

Non-randomized

Parallel assignment

Phase 4

Autologous MSC

Hepatic artery

Safety, MELD score, Child Pugh score, percentage of CD34 cells

2020

NCT04243681

  1. ALT alanine aminotransferase, AST aspartate aminotransferase, TB total bilirubin, PT prothrombin time, ALB albumin, PA prealbumin, GGT γ-glutamyltransferase, ALP alkaline phosphatase, MELD Model for End-stage Liver Disease, INR International Normalized Ratio, MSC mesenchymal stromal/stem cell, BM bone marrow, UC umbilical cord, AD adipose tissue, OS overall survival, HCC hepatocellular carcinoma
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Cell & Bioscience

ISSN: 2045-3701

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