hUC Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosishepatitis b Cirrhosis
Recruiting · NCT03826433 · Interventional (participants receive a specific treatment) · Lead sponsor: Sclnow Biotechnology Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
Peripheral iv
What this trial is about
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.
Who can take part
Age range
18 Years to 60 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Xiangya Hospital Central South University - Changsha, Hunan, China