hUC Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosishepatitis b Cirrhosis

Sclnow Biotechnology

Status and phase: Enrolling; Phase 1

Conditions: Hepatitis B

Treatments: Biological: Peripheral iv

Study type: Interventional

Funder types: Industry

Identifiers

NCT03826433

SCLnow-XY-04

Details and patient eligibility

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Treatment Group

Experimental group

Description:

Mesenchymal Stem Cells : through peripheral intravenous slowly, every time 6\*10\^7 (30ml) Other medication of Treatment Group: before the30min of first time to inject stem cells, Intravenous methylprednisone 20mg. All patients require oral nucleoside drugs resistant hepatitis B virus treatment.Use stem cell therapy, by Peripheral iv, 6 \* 10 \^ 7 (30 ml)

Treatment:

Biological: Peripheral iv

Control Group

No Intervention group

Description:

Control Group: Using basic contrast .