Could umbilical cord stem cells repair damaged livers?
NCT ID NCT07413549
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether stem cells from umbilical cords can safely help people with severe liver scarring caused by hepatitis B. The trial involves 76 adults who will receive the stem cells through a vein. Researchers will check for side effects and measure if liver function improves.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- human umbilical cord mesenchymal stem cells
- What this could lead to
- If it works, this could offer a new way to improve liver function and reduce complications in people with advanced hepatitis B cirrhosis.
- What could go wrong
- This is an early phase 1-2 trial with only 76 participants, so results may not apply broadly. Stem cell treatments carry risks like infection or immune reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 76 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Zhongnan Hospital of Wuhan University
RECRUITINGWuhan, China
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