Phase 2 Hepatitis B Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged between 18 and 75 years old at the time of screening, of any gender.
• People who have been diagnosed with decompensated hepatitis B cirrhosis with a history of complications related to high blood pressure in the liver's portal vein, based on specific 2019 Chinese medical guidelines.
• People who have had at least 3 months of thorough standard medical treatment — including antiviral medications, liver-supportive care, and nutritional support — without significant improvement in cirrhosis symptoms or quality of life, and where the trial doctor considers stem cell therapy appropriate.
• People whose hepatitis B virus (HBV) levels in the blood are below a specific low threshold at the time of screening.
• People who are not suitable for a liver transplant, or for whom a donor liver is not available.
• People (and their partners) who have no plans to become pregnant from the time of screening until at least 6 months after the trial ends, and who agree to use effective non-hormonal contraception throughout the trial.
• People who have read and understood the informed consent form and have agreed in writing to take part voluntarily.

Who may not be able to join:

• People whose liver cirrhosis is caused by something other than hepatitis B — for example, alcohol-related liver disease, hepatitis C, autoimmune hepatitis, or a condition related to fat buildup in the liver (MASLD).
• People with a liver disease severity score (Child-Pugh score) greater than 12 points.
• People who have a personal history of cancer in the liver or any other organ, or whose close biological relatives have a history of liver cancer.
• People who, in the trial doctor's judgement, have serious other medical conditions that could affect the safety or results of the treatment — such as significant heart problems (Class III or above by NYHA standards), heart attack or unstable chest pain, poorly controlled diabetes, or significantly reduced kidney function.
• People who have had recent uncontrolled bleeding in the digestive tract — for example, active or severe bleeding within the past 3 months, or a major upper digestive tract bleeding event within the past 4 weeks — where the trial doctor considers participation unsuitable.
• People who have experienced a serious confusion episode related to liver failure (hepatic encephalopathy) or a combined liver-kidney failure condition (hepatorenal syndrome) within the 3 months before screening.
• People who have had a serious abdominal infection (spontaneous bacterial peritonitis) or any severe active infection within the 2 weeks before screening.
• People who test positive for HIV, hepatitis C, syphilis, or who have active tuberculosis.
• People who have received human albumin (a protein infusion) within 3 weeks before the first treatment dose.
• People with a history of blood clots in the veins or lungs, where the trial doctor considers participation unsuitable.
• People with a history of drug addiction or significant alcohol misuse.
• People who are pregnant or currently breastfeeding.
• People who have a known allergy to any ingredient in umbilical cord mesenchymal stem cells or their preparation, or who have a history of severe drug allergies or a generally highly allergic constitution.
• People who have had a serious psychiatric condition within the past 24 months, including severe uncontrolled depression or psychosis (whether currently controlled or not).
• People who are currently participating in, or have participated in, another interventional clinical trial within the past 3 months, or who have previously received any form of stem cell therapy.
• People who are planning to have a liver transplant within 3 months after screening.
• People who, for any other reason, the trial doctor considers unsuitable for participation.

Important: Always verify eligibility with the trial site directly before applying.