Umbilical cord mesenchymal stem cell injections for decompensated hepatitis B cirrhosis

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

This trial will test whether injections of umbilical-cord-derived mesenchymal stem cells can help people with decompensated hepatitis B cirrhosis.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing Tuohua Weiye Biotechnology Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Wuhan)
• Trial ID: NCT07413549 on ClinicalTrials.gov

What this trial studies

The trial uses a two-part design: Phase I is a randomized, double-blind, single-administration dose-escalation to determine safety and a tolerated dose, and Phase II is a randomized, double-blind dose-expansion with multiple administrations to gather preliminary efficacy data. Secondary and exploratory outcomes include measures of liver function, pharmacokinetics of the cell product, and immunogenicity. Participants must have decompensated hepatitis B cirrhosis despite at least three months of conservative therapy, low HBV DNA, and be unsuitable for transplantation. The intervention is intravenous injection of human umbilical cord mesenchymal stem cells with follow-up at the Zhongnan Hospital of Wuhan University.

Who should consider this trial

Good fit: Adults aged 18–75 with decompensated hepatitis B cirrhosis, portal hypertension-related complications, HBV DNA <2×10^3 IU/mL after standard antiviral/conservative therapy, and who are not candidates for liver transplantation are the intended participants.

Not a fit: Patients with uncontrolled active HBV replication, other primary causes of liver failure, major contraindications to cell therapy, or who are eligible and awaiting transplant are less likely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the treatment could improve liver function and reduce complications, potentially delaying or avoiding the need for liver transplantation.

How similar studies have performed: Small clinical studies of mesenchymal stem cells in liver cirrhosis have generally shown acceptable safety and some functional improvements, but results are mixed and not yet definitive.

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).
* 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 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.
* 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.

Where this trial is running

Wuhan

• Zhongnan Hospital of Wuhan University — Wuhan, China (Recruiting)

Study contacts

• Study coordinator: Shi Cheng

Conditions Decompensated Hepatitis B Cirrhosis; UC-MSCs; decompensated hepatitis B cirrhosis