NCT03826433RecruitingPhase 1
hUC Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosishepatitis b Cirrhosis
Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosis
Source: ClinicalTrials.gov · Last updated 23 Apr 2026
Brief summary (registry, in English)
1. Evaluation the safety of using human umbilical mesenchymal stem cells to treat patients with hepatitis B cirrhosis. 2. Observe the curative effect of patients with hepatitis B cirrhosis who use human umbilical mesenchymal stem cells to treat. 3. Explore the possible mechanism of human umbilical mesenchymal stem cells to treat patients with hepatitis B cirrhosis.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 14 Jan 2019
- Start date
- 1 Oct 2018
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Sclnow Biotechnology Co., Ltd.
- Diseases
- Hepatitis B
- NCT number
- NCT03826433
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 20
- From 1 Oct 2018 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant peritonitis, pneumonia, or other types of infection not under control;
Other illness
- 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.
- Have a history of severe allergic reaction or allergy to two or more kinds of food or medicine;
- 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;
Lab values
- Positive serum HIV antibody and syphilis antibody;
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xiangya Hospital Central South University Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.