NCT05948982

Safety of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in Patients With Decompensated Hepatitis B Cirrhosis

Not yet recruiting Phase 1, PHASE2 Last updated 17 July 2023

What this trial tests

Phase 1, PHASE2 trial testing Human Umbilical Cord Mesenchymal Stem Cells in Decompensated Liver Cirrhosis in 18 participants. Not yet recruiting.

Timeline

30 July 2023

Primary endpoint
31 December 2026

31 December 2026

Quick facts

Lead sponsor	Asia Cell Therapeutics (Shanghai) Co., Ltd.
Phase	Phase 1, PHASE2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	30 July 2023
Primary completion	31 December 2026
Estimated completion	31 December 2026

Drugs / interventions tested

• Human Umbilical Cord Mesenchymal Stem Cells

Conditions studied

• Decompensated Liver Cirrhosis — all drugs for Decompensated Liver Cirrhosis →

Sponsor

Asia Cell Therapeutics (Shanghai) Co., Ltd.

Who can join

Adults 18 to 75, any sex, with Decompensated Liver Cirrhosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to evaluate the safety and tolerability of multiple doses of human umbilical cord mesenchymal stem cell injection in patients with decompensated hepatitis B cirrhosis, and to further explore the efficacy, pharmacodynamic profile and appropriate dose of administration to provide a basis for the use of safer and more effective treatments for patients with decompensated hepatitis B cirrhosis in the future.

Participants are required to sign an informed consent form and, after undergoing a series of tests and meeting the protocol's entry and exclusion criteria, are assigned to a dose group for intravenous infusion of human umbilical cord mesenchymal stem cells.

Publications & conference data

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

1. Stem cell-based therapy for fibrotic diseases: mechanisms and pathways.
   Taherian M, Bayati P, Mojtabavi N. · · 2024 · cited 18× · PMID 38886859 · DOI 10.1186/s13287-024-03782-5
2. 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
3. From signaling pathways to clinical trials: mesenchymal stem cells as multimodal regenerative architects in liver cirrhosis therapy.
   Bozorgi V, Babaahmadi M, Salehi M, Vafaeimanesh J, et al · · 2025 · cited 4× · PMID 40764597 · DOI 10.1186/s13287-025-04535-8
4. Stem Cell Therapies for Gastrointestinal and Liver Diseases: Translational Barriers, Clinical Heterogeneity, and Future Directions.
   Nikolaev G, Lozenov S, Konaktchieva M, Arabadzhiev B, et al · · 2026 · PMID 42193425 · DOI 10.3390/biomedicines14051102
5. Modular mastery of inflammation: umbilical cord mesenchymal stem cells as a therapeutic frontier.
   Yin L, Sun CY, Chen GL, Xiang Z, et al · · 2025 · PMID 41488628 · DOI 10.3389/fimmu.2025.1721947