Clinical trial NCT03826433: hUC Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosishepatitis b Cirrhosis
Official title: Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hepatitis B
Keywords: Hepatitis B Cirrhosis, mesenchymal stem cell
Lead sponsor: Sclnow Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-02-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This experimental use umbilical cord mesenchymal stem cells in treatment of decompensated hepatitis B cirrhosis to evaluate its safety and efficacy,

This experimental is mainly aimed at people aged 18-60 years old, regardless of gender and with body mass index (BMI) between 19-25kg/m2 (including boundary value). It was decided into treatment group and control group to evaluate the effectiveness and safety of mesenchymal stem cells by peripheral intravenous injection.

Eligibility criteria: 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;

Primary outcomes:
measure: Validity evaluation by detection of the Model for end-stage Liver Disease score of participants
timeFrame: 12 month
Secondary outcomes:
measure: Safety evaluation by detecting Blood routine
timeFrame: 12 month
measure: Validity evaluation by detection of the child-pugh of participants
timeFrame: 12 month
Other outcomes:
measure: Validity evaluation by detection of the coagulation function of participants
timeFrame: 12 month
measure: Imaging examination
timeFrame: 12 month
measure: Imaging examination
timeFrame: 12 month
measure: Safety evaluation by detecting adverse events and serious adverse events
timeFrame: 12 month
Locations:
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University
name: Xuegong Fan, doctor
role: STUDY_DIRECTOR
References: