drugset / Trial / NCT05948982

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

NCT05948982

Phase 1/2 Not yet recruiting 18 enrolled Asia Cell Therapeutics (Shanghai) Co., Ltd.
NaSequentialOpen-labelTreatment

Summary

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.

Timeline

Start
2023-07-30
Primary completion
2026-12-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject human umbilical cord mesenchymal stem cells Cell therapy 1e+06 cells/kg Intravenous
Subject human umbilical cord mesenchymal stem cells Cell therapy 2e+06 cells/kg Intravenous
Subject human umbilical cord mesenchymal stem cells Cell therapy 4e+06 cells/kg Intravenous

Indications