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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
Are there results?
Not yet: the study is under way

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.

Shi Cheng contact

+8618504341228

thswcs@163.com

China1 site, 1 recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan

    Yufeng Yuan, +8613995564795, yuanyf1971@whu.edu.cn

    Recruiting

Other trials in China

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.

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 groups in NCT07413549
Study groupRoleWhat they receive
Human Umbilical Cord Mesenchymal Stem Cells Injection 5 × 10^7 cells per person per administrationExperimentalDuration 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 administrationExperimentalDuration 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 administrationExperimentalDuration 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.

  1. 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

  2. Determine the recommended dose for phase II（RP2D）

    Safety Indicator

    Measured: Periprocedural

Secondary outcomes (12)

  1. 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

  2. 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

  3. Hepatic hardness changes from baseline

    Efficacy Endpoint

    Measured: Week 24, week 52 after administration

  4. Spleen hardness changes from baseline

    Efficacy Endpoint

    Measured: Week 24, week 52 after administration

  5. 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

  6. 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

  7. 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

  8. 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

  9. Change in HBV DNA from Baseline

    Efficacy Endpoint

    Measured: Week 1, week 2, week 8, week 24, week 36, week 52 after administration

  10. Liver transplant-free survival

    Efficacy Endpoint

    Measured: Periprocedural

  11. 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

  12. 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.

  1. First posted17 Feb 2026
  2. Study start25 Feb 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shi Cheng (+8618504341228, thswcs@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and characteristics of any adverse events and serious adverse events associated with human umbilical cord mesenchymal stem cell injection therapy (time frame: within 28 days after administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07413549.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.

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