Umbilical Cord Stem Cell Injection for Advanced Hepatitis B Liver Cirrhosis
Tests umbilical cord stem cell injections in adults with decompensated hepatitis B cirrhosis.
Plain-language title generated from the registry record
Registry title: Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells Injection in Patients With Decompensated Hepatitis B Cirrhosis
Key facts
- Where
- Wuhan, ChinaSee the site
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with decompensated cirrhosis caused by hepatitis B, whose symptoms did not improve after at least 3 months of standard medical treatment.
- Age
- 18 to 75 years
- Sex
- All sexes can join
- Disease stage
- Decompensated hepatitis B cirrhosis with a history of complications from high pressure in the liver blood vessels (portal hypertension). Child-Pugh score must not be above 12 points.
- Earlier treatment
- At least 3 months of strict medical treatment (antiviral drugs, liver-protecting drugs, symptom relief and nutritional support) without clear improvement. No earlier stem cell therapy. No other interventional trial in the last 3 months.
- Biomarker or test result
- HBV DNA below 2 × 10³ IU/mL at screening.
Main reasons for not taking part
- Cirrhosis from another cause, such as alcohol, hepatitis C, autoimmune hepatitis or fatty liver disease
- History of cancer of the liver or other organs, or liver cancer in a parent, brother, sister or child
- Positive test for HIV, hepatitis C or syphilis, or active tuberculosis
- Pregnant or breastfeeding women
- Recent serious bleeding, hepatic encephalopathy, hepatorenal syndrome or severe infection
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07413549, who can take part
Where in China
- Zhongnan Hospital of Wuhan UniversityWuhan, ChinaContact: Yufeng YuanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Beijing Tuohua Weiye Biotechnology Co., Ltd.
- Trial code
- NCT07413549
- Record updated
- 17 February 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Recent uncontrolled gastrointestinal bleeding (e.g., severe bleeding tendency or active bleeding within 3 months prior to screening, or clinically significant major upper gastrointestinal bleeding event within 4 weeks prior to screening), deemed unsuitable for the trial by the investigator; Occurrence of hepatic encephalopathy or hepatorenal syndrome within 3 months prior to screening; Presence of spontaneous bacterial peritonitis or severe active infection within 2 weeks prior to screening; Drug addiction or alcohol abuse; History of severe psychiatric disorders within 24 months prior to screening, including uncontrolled severe depression or controlled/uncontrolled psychosis; Participation in other interventional clinical trials within 3 months prior to screening or currently, or previous receipt of stem cell therapy; Planned liver transplantation within 3 months after screening; Cirrhosis due to other causes, such as alcoholic hepatitis, hepatitis C virus infection, autoimmune hepatitis, and metabolic dysfunction-associated steatotic liver disease (MASLD); History of malignancy in the liver or other organs, or a family history of liver malignancy in first-degree relatives; History of venous thrombosis or pulmonary embolism, deemed unsuitable for the trial by the investigator; Allergy to any component of the umbilical cord mesenchymal stem cells or excipients, or history of severe drug allergy or allergic constitution; Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this clinical trial; The investigator judges that the subject currently has severe internal medical diseases that would affect the safety and efficacy evaluation of the treatment, such as: cardiovascular diseases including cardiac function abnormality of Class III or above (according to NYHA criteria), ischemic heart disease (e.g., myocardial infarction or unstable angina), poorly controlled diabetes (fasting blood glucose ≥ 10 mmol/L or glycosylated hemoglobin (HbA1c) ≥ 8%), serum creatinine > 2 times the upper limit of normal (ULN), etc; Positive results in infectious disease serology (positive for serum anti-HIV antibody, anti-HCV antibody, or syphilis antibody) or patients with active tuberculosis; Use of human albumin within 3 weeks prior to the first infusion of the investigational product; Child-Pugh score > 12 points; Pregnant or lactating women.