RecruitingPhase 1/2

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

China76 participantsStarted 2025-02-25

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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). * After at least 3 months of strict conservative medical treatment (including antiviral therapy with nucleos(t)ide analogues, hepatoprotective, symptomatic, and nutritional support therapy), there has been no significant alleviation of cirrhosis symptoms or improvement in quality of life scores, and the investigator deems the subject suitable for stem cell therapy. * HBV DNA level \< 2 × 10³ IU/mL at screening. * Not suitable for liver transplantation, or lacking a liver donor source. * Both the subject and their partner have no plans for pregnancy from screening until 6 months after the end of the trial and agree to use effective non-pharmacological contraception during the trial period. * Fully understand the informed consent form, voluntarily participate in the trial, and sign the informed consent form. Exclusion Criteria: * Cirrhosis due to other causes, such as alcoholic hepatitis, hepatitis C virus infection, autoimmune hepatitis, and metabolic dysfunction-associated steatotic liver disease (MASLD). * Child-Pugh score \> 12 points. * History of malignancy in the liver or other organs, or a family history of liver malignancy in first-degree relatives. * The investigator ju…

What they're measuring

Incidence and characteristics of any adverse events and serious adverse events associated with human umbilical cord mesenchymal stem cell injection therapy

Timeframe: within 28 days after administration

Determine the recommended dose for phase II（RP2D）

Timeframe: Periprocedural

Trial details

NCT IDNCT07413549

SponsorBeijing Tuohua Weiye Biotechnology Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Shi Cheng

+8618504341228 thswcs@163.com