Decompensated Hepatitis B CirrhosisPhase 1/2HBV-DCNCT07413549
Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells Injection in Patients With Decompensated Hepatitis B Cirrhosis
A Phase 1/2 study testing Human Umbilical Cord Mesenchymal Stem Cells Injection in people with Decompensated Hepatitis B Cirrhosis, run by Beijing Tuohua Weiye Biotechnology Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Decompensated Hepatitis B Cirrhosis
- What is being tested?
- Human Umbilical Cord Mesenchymal Stem Cells Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2025to 31 Dec 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 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.
- 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.
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- Presence of spontaneous bacterial peritonitis or severe active infection within 2 weeks prior to screening.
- 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.
- History of venous thrombosis or pulmonary embolism, deemed unsuitable for the trial by the investigator.
- Drug addiction or alcohol abuse.
- Pregnant or lactating women.
- Allergy to any component of the umbilical cord mesenchymal stem cells or excipients, or history of severe drug allergy or allergic constitution.
- 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.
- Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan
Yufeng Yuan, +8613995564795, yuanyf1971@whu.edu.cn
About this study
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
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.
- Conditions
- Decompensated Hepatitis B Cirrhosis
- Being tested
- Human Umbilical Cord Mesenchymal Stem Cells Injection
- Keywords
- UC-MSCs, decompensated hepatitis B cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Umbilical Cord Mesenchymal Stem Cells InjectionBiological
venous reinfusion
| Study group | Role | What they receive |
|---|---|---|
| Human Umbilical Cord Mesenchymal Stem Cells Injection 5 × 10^7 cells per person per administration | Experimental | Duration of administration: single dose Receives: Biological: Human Umbilical Cord Mesenchymal Stem Cells Injection |
| Human Umbilical Cord Mesenchymal Stem Cells Injection 1×10^8cells per person per administration | Experimental | Duration of administration: single dose Receives: Biological: Human Umbilical Cord Mesenchymal Stem Cells Injection |
| Human Umbilical Cord Mesenchymal Stem Cells 2×10^8cells per person per administration | Experimental | Duration of administration: single dose Receives: Biological: Human Umbilical Cord Mesenchymal Stem Cells Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and characteristics of any adverse events and serious adverse events associated with human umbilical cord mesenchymal stem cell injection therapy
Safety Indicator
Measured: within 28 days after administration
Determine the recommended dose for phase II（RP2D）
Safety Indicator
Measured: Periprocedural
Secondary outcomes (12)
Change of Model for End-stage Liver Disease score from baseline
The calculated baseline score is 6 points. The 40-point mark is an upper limit set in clinical application, used to indicate an extremely high risk of mortality and to guide the most urgent allocation of liver transplants.
Efficacy Endpoint
Measured: Week 1, week 2, week 4, week 8, week 12, week 24, week 36, week 52 after administration
Child-Pugh score change from baseline
The theoretical minimum score of the Child-Pugh classification is 5 points, and the maximum is 15 points. A higher score indicates poorer liver reserve function and a less optimistic prognosis for the patient Efficacy Endpoint
Measured: Week 1, week 2, week 4, week 8, week 12, week 24, week 36, week 52 after administration
Hepatic hardness changes from baseline
Efficacy Endpoint
Measured: Week 24, week 52 after administration
Spleen hardness changes from baseline
Efficacy Endpoint
Measured: Week 24, week 52 after administration
Change in Liver Function Indicators from Baseline: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Total Bilirubin (TBIL), Gamma-Glutamyl Transferase (γ-GGT), Alkaline Phosphatase (ALP), Albumin (ALB), Cholinesterase (CHE)
Efficacy Endpoint
Measured: Week 1, week 2, week 4, week 8, week 12, week 24, week 36, week 52 after administration
Change in International Normalized Ratio from Baseline
Efficacy Endpoint
Measured: Week 1, week 2, week 4, week 8, week 12, week 24, week 36, week 52 after administration
Prothrombin Time from Baseline
Efficacy Endpoint
Measured: Week 1, week 2, week 4, week 8, week 12, week 24, week 36, week 52 after administration
Prothrombin Activity from Baseline
Efficacy Endpoint
Measured: Week 1, week 2, week 4, week 8, week 12, week 24, week 36, week 52 after administration
Change in HBV DNA from Baseline
Efficacy Endpoint
Measured: Week 1, week 2, week 8, week 24, week 36, week 52 after administration
Liver transplant-free survival
Efficacy Endpoint
Measured: Periprocedural
The incidence of complications related to decompensated cirrhosis (the following complications were calculated separately: esophageal and gastric varices bleeding, sepsis, hepatic encephalopathy, hepatorenal syndrome)
Efficacy Endpoint and Safety Indicator
Measured: Periprocedural
Incidence and Characteristics of Any Treatment-Related Adverse Events and Serious Adverse Events Associated with Human Umbilical Cord Mesenchymal Stem Cell Injection Therapy
Safety Indicator
Measured: Week 5 to week 52 after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start25 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompensated Hepatitis B CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tuohua Weiye Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413549
- Sponsor's protocol ID
- TH-hUC-MSCs-101
- Other IDs
- CTR20250073
- Acronym
- HBV-DC
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No