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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Study of hUC-MSCs Treating Decompensated Liver Cirrhosis With HBV

NCT05442437

HBV

COMPLETED EARLY_PHASE1

Umbilical Cord Mesenchymal Stem Cell Transplantation for Decompensated Hepatitis B Cirrhosis

NCT05106972

Liver Cirrhosis

RECRUITING NA

Human Umbilical Cord-derived Mesenchymal Stem Cells for Decompensated Cirrhosis (MSC-DLC-1b)

NCT05984303

Decompensated Cirrhosis

UNKNOWN PHASE1

Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic Cirrhosis

NCT02652351

Hepatic Cirrhosis

UNKNOWN PHASE1

Safety of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in Patients With Decompensated Hepatitis B Cirrhosis

NCT05948982

Decompensated Liver Cirrhosis

NOT_YET_RECRUITING PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatitis B

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment Group

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)

Group Type EXPERIMENTAL

Peripheral iv

Intervention Type BIOLOGICAL

6\*10\^7 cells

Control Group

Control Group: Using basic contrast .

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Peripheral iv

6\*10\^7 cells

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No