Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells Injection in Patients With Decompensated Hepatitis B Cirrhosis

Recruiting Phase 1 Phase 2 Interventional Study
Decompensated Hepatitis B Cirrhosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
76 (estimated)
Sponsor
Beijing Tuohua Weiye Biotechnology Co., Ltd. · Industry
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Aged between 18 and 75 years (inclusive) at screening, regardless of gender. * Diagnosed with decompensated hepatitis B cirrhosis with a history of portal hypertension-related complications according to the Guidelines for the Diagnosis and Treatment of Cirrhosis (2019 Edition)…
Contacts

Shi Cheng

+8618504341228

thswcs@163.com

CONTACT