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Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells Injection in Patients With Decompensated Hepatitis B Cirrhosis
Sponsor: Beijing Tuohua Weiye Biotechnology Co., Ltd.
Summary
Phase I (Single Administration, Randomized, Double-blind, Dose Escalation)Primary Objective: To evaluate the safety and tolerability of Human Umbilical Cord Mesenchymal Stem Cell Injection in patients with decompensated hepatitis B cirrhosis, and to determine the safe clinical dose.Secondary Objective: To evaluate the preliminary efficacy of Human Umbilical Cord Mesenchymal Stem Cell Injection in patients with decompensated hepatitis B cirrhosis, providing a basis for the design of subsequent clinical trial protocols.Exploratory Objective: To evaluate the pharmacokinetic characteristics and immunogenicity of Human Umbilical Cord Mesenchymal Stem Cell Injection in patients with decompensated hepatitis B cirrhosis.Phase II (Multiple Administrations, Randomized, Double-blind, Dose Expansion)Primary Objective: To evaluate the preliminary efficacy of Human Umbilical Cord Mesenchymal Stem Cell Injection in patients with decompensated hepatitis B cirrhosis.Secondary Objective: To evaluate the safety of Human Umbilical Cord Mesenchymal Stem Cell Injection in patients with decompensated hepatitis B cirrhosis.Exploratory Objective: To evaluate the pharmacokinetic characteristics and immunogenicity of Human Umbilical Cord Mesenchymal Stem Cell Injection in patients with decompensated hepatitis B cirrhosis.
Official title: A Phase I-II Clinical Study on the Safety, Tolerability, and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell Injection in Patients With Decompensated Hepatitis B Cirrhosis
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
76
Start Date
2025-02-25
Completion Date
2027-12-31
Last Updated
2026-02-17
Healthy Volunteers
No
Conditions
Interventions
Human Umbilical Cord Mesenchymal Stem Cells Injection
venous reinfusion
Locations (1)
Zhongnan Hospital of Wuhan University
Wuhan, China