drugset / Trial / NCT03460795

Safety and Efficacy Study of Co-transfering of Mesenchymal Stem Cell and Regulatory T Cells in Treating End-stage Liver Disease

NCT03460795

Phase 1/2 Unknown 30 enrolled Nanjing Medical University
NaSingle-groupOpen-labelTreatment

Summary

Cirrhosis of the liver is a common clinical chronic progressive liver disease, which is a diffuse liver lesion caused by one or more causes over a long period of time or repeatedly. Nodules, abnormal spherical areas of cells, form as dying liver cells are replaced by regenerating cells. This regeneration of cells causes the liver to become hard. The potential for stem cells to differentiate into hepatocytes cells was recently confirmed. In particular, mesenchymal stem cell (MSC) transplantation has been applicated in the clinic for treat several human diseases such as liver injury and liver fibrosis displayed good tolerance and efficiency. Besides, regulatory T cells(Tregs) had been proved as an immune regualtory T cell subsets, which could reduce immune cell activation and reduce liver injury severity. The purpose of this study is to learn whether and how MSCs and Tregs can improve the disease conditions in patients with decompensated cirrhosis.

Timeline

Start
2020-06-01
Primary completion
2025-03-01
Completion
2025-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Mesenchymal stem cell Cell therapy
Subject Tregs Cell therapy

Indications