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hUC-MSCs in Decompensated Hepatitis B Cirrhosis
NCT07413549Phase 2
Key facts
- Status
- Recruiting
- Start
- Feb 2025
- Primary completion
- Dec 2026
- Countries
- 1
- Sponsor
- Tuohua Weiye
- Modality
- Stem Cell Therapies
- Conditions
- hepatitis B-related cirrhosis
01
Overview
Phase 2, randomised, double-blind trial of human umbilical cord mesenchymal stem cells in hepatitis B-related cirrhosis, sponsored by Tuohua Weiye. Primary endpoints: Incidence and characteristics of any adverse events and serious adverse events at 28 days and Recommended dose for phase II. Started Feb 2025; status: recruiting.
02
Design
- Study design
- RandomizedDouble-blind
03
Who it enrols
Adults aged 18-75 with decompensated hepatitis B cirrhosis who have failed at least 3 months of conservative treatment, have low HBV DNA levels, and are not suitable for liver transplantation.
04
Endpoints
Primary
Incidence and characteristics of any adverse events and serious adverse events
Recommended dose for phase II
Secondary
Change of Model for End-stage Liver Disease score from baseline
Child-Pugh score change from baseline
Hepatic hardness changes from baseline
Spleen hardness changes from baseline
Change in Liver Function Indicators from Baseline: ALT, AST, TBIL, GGT, ALP, ALB, CHE
Change in International Normalized Ratio from Baseline
Prothrombin Time from Baseline
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