NCT03863002

Safety and Efficacy of Mesenchymal Stem Cell Transplantation for Acute-on-Chronic Liver Failure

Status unknown Phase 1, PHASE2 Last updated 20 March 2019

What this trial tests

Phase 1, PHASE2 trial testing Mesenchymal Stem Cell in Liver Failure, Acute on Chronic in 45 participants. Status unknown.

Timeline

1 October 2019

Primary endpoint
1 October 2021

1 October 2022

Quick facts

Lead sponsor	Tianjin Weikai Bioeng., Ltd.
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	45
Start date	1 October 2019
Primary completion	1 October 2021
Estimated completion	1 October 2022
Sites	1 location across China

Drugs / interventions tested

• Mesenchymal Stem Cell

Conditions studied

• Liver Failure, Acute on Chronic — all drugs for Liver Failure, Acute on Chronic →

Sponsor

Tianjin Weikai Bioeng., Ltd.

Who can join

Adults 16 to 60, any sex, with Liver Failure, Acute on Chronic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Safety and Efficacy of Mesenchymal Stem Cell Transplantation for Acute-on-Chronic Liver Failure

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mesenchymal Stromal/Stem Cells and Their Extracellular Vesicles Application in Acute and Chronic Inflammatory Liver Diseases: Emphasizing on the Anti-Fibrotic and Immunomodulatory Mechanisms.
   Hazrati A, Malekpour K, Soudi S, Hashemi SM. · · 2022 · cited 38× · PMID 35464407 · DOI 10.3389/fimmu.2022.865888
2. Application of mesenchymal stem cell exosomes and their drug-loading systems in acute liver failure.
   Zhang S, Hou Y, Yang J, Xie D, et al · · 2020 · cited 32× · PMID 32492261 · DOI 10.1111/jcmm.15290
3. Locoregional delivery of stem cell-based therapies.
   Ng NN, Thakor AS. · · 2020 · cited 24× · PMID 32522806 · DOI 10.1126/scitranslmed.aba4564
4. Mesenchymal stem cell therapy as a game-changer in liver diseases: review of current clinical trials.
   Huang WC, Li YC, Chen PX, Ma KS, et al · · 2025 · cited 14× · PMID 39762946 · DOI 10.1186/s13287-024-04127-y
5. The role of mesenchymal stem cells in liver injury.
   Sun H, Shi C, Ye Z, Yao B, et al · · 2022 · cited 14× · PMID 34882906 · DOI 10.1002/cbin.11725
6. Cell and Tissue Therapy for the Treatment of Chronic Liver Disease.
   Bram Y, Nguyen DT, Gupta V, Park J, et al · · 2021 · cited 12× · PMID 33974812 · DOI 10.1146/annurev-bioeng-112619-044026
7. Cell therapy for end-stage liver disease: Current state and clinical challenge.
   Zhang L, Deng Y, Bai X, Wei X, et al · · 2024 · cited 5× · PMID 39602326 · DOI 10.1097/cm9.0000000000003332
8. Stem cell-based therapeutic strategies for liver aging.
   Niu H, Wang YN, Ding Y, Lin YQ, et al · · 2025 · cited 1× · PMID 40620500 · DOI 10.1016/j.livres.2025.04.003