Using stem cells to treat hepatitis B cirrhosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of human umbilical mesenchymal stem cells in treating patients with decompensated hepatitis B cirrhosis. Participants aged 18-60 with a specific BMI range will receive peripheral intravenous injections of the stem cells. The study aims to observe the therapeutic effects and explore the underlying mechanisms of treatment. It is designed as a controlled trial comparing treatment and control groups.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18-60 years old, gender not limited, body mass index (BMI) between 19-25 kg/m2, including boundary value;
* The diagnosis of hepatitis B cirrhosis was in line with the 2015 American society of hepatology (AASLD) guidelines for the treatment of chronic hepatitis B, and the liver function grade was child-pugh B or child-pugh C, with a score range of 7-12 points, and Model for End-Stage Liver Disease score≤21 points.
* Have not received stem cell therapy in the recent 6 months;
* Subjects will be able to sign the informed consent in accordance with the study procedures and instructions.

Exclusion Criteria:

* Insufficiency of vital organs, such as heart, kidney and lung;
* End-stage cirrhosis with severe complications, including but not limited to: hepatic encephalopathy, gastrointestinal bleeding,Severe bleeding tendency, massive ascites, etc.
* Concomitant peritonitis, pneumonia, or other types of infection not under control;
* Have a history of severe allergic reaction or allergy to two or more kinds of food or medicine;
* Positive serum HIV antibody and syphilis antibody;
* Alpha fetoprotein\>400ng/mL with primary liver cancer or without imaging evidence;
* Chronic liver disease and cirrhosis are caused by non-chronic hepatitis B virus infection, or other factors except chronic hepatitis B virus infection ;
* Patients with severe mental illness and cognitive impairment;

Where it's running

• Xiangya Hospital Central South University
  Changsha, Hunan, China Recruiting

Study contacts

• Study coordinator: Lei Guo, doctor
• Email: georgeguo@sclnow.com
• Phone: 861064368977

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.