Study of Human Umbilical Cord Mesenchymal Stem Cell in Patients With Cirrhosis Due to Hepatitis B (Compensation Stage)

August 18, 2022 updated by: Jiang Yingan, Renmin Hospital of Wuhan University

A Randomized, Double-blind, Controlled Clinical Study of Human Umbilical Cord Mesenchymal Stem Cell in Patients With Cirrhosis Due to Hepatitis B (Compensation Stage)

There are about 240 million chronic hepatitis B virus (HBV) infected people in the world, and about 2%-5% of compensated cirrhosis patients progress to decompensated cirrhosis patients every year. Studies have shown that the 5-year survival rate of decompensated cirrhosis is only 14-35%, and the quality of life and prognosis of patients are poor. Reversing or delaying the process of cirrhosis and reducing the development of compensated cirrhosis to decompensated cirrhosis is one of the effective methods for liver disease treatment. MSCs are mainly derived from bone marrow, but bone marrow mesenchymal stem cells have some shortcomings, such as cumbersome sampling, and the proliferation and differentiation ability of bone marrow mesenchymal stem cells decrease obviously with the age of donors, which is not conducive to cell therapy. Umbilical cord has many advantages, such as wide source, convenient collection, small immune rejection, and small ethical controversy, which makes it a hot spot in stem cell research and has a wider prospect in cell therapy. This clinical study will explore the efficacy and safety of human umbilical cord-derived mesenchymal stem cells in the treatment of hepatitis B virus-infected patients with compensated cirrhosis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

There are about 1.7 billion people with different types of chronic liver diseases in the world, of which about 240 million are infected with chronic hepatitis B virus (HBV), and about 15%-40% of chronic hepatitis B can develop into liver cirrhosis and die of liver hardness every year There are hundreds of thousands of patients. There are about 90 million hepatitis B carriers in China, including about 20 million chronic hepatitis B carriers. Every year, about 2%-5% of compensated cirrhosis patients progress to decompensated cirrhosis patients. Studies have shown that the 5-year survival rate of decompensated liver cirrhosis is only 14-35%, and the quality of life and prognosis of patients are poor. From the progression of liver fibrosis to the decompensation of liver cirrhosis, liver failure often occurs. Statistics show that slow increase The 28-day mortality rate of patients with acute liver failure of grade 1, 2 and 3 is as high as 22%, 32% and 77%. The 90-day mortality rate was 41%, 73%, 95%. Orthotopic liver transplantation is the most effective means to treat decompensated liver failure due to liver cirrhosis, However, the shortage of donor liver, immune rejection and high cost have become treatment obstacles. Application of artificial liver support system for blood flow Plasma replacement can remove toxic substances from blood, but it can't supplement albumin and coagulation factors, and it is important to whether reducing the mortality rate is still controversial. Therefore, it reverses or delays the process of liver cirrhosis and reduces the compensatory stage of liver cirrhosis It is an important link in the treatment of liver diseases that the patients develop into decompensated stage The curative effect of medical treatment on hepatitis B cirrhosis (compensatory period) is very limited; Liver transplantation is difficult to popularize in clinical application due to the lack of donors and high cost. Mesenchymal Stem Cells (MSCs) are derived from mesoderm in early development, is a high degree of self-renewal ability, Pluripotent stem cells with high proliferation ability and multidirectional differentiation potential widely exist in bone marrow, fat, umbilical cord blood, umbilical cord, and other tissues. They can be cultured and expanded in vitro, and can differentiate into adipocytes, osteoblasts, cartilage tissues, nerve cells, hepatocytes and so on under the control of specific conditions, which has great application value in cell therapy and tissue engineering. The purpose of this study was to investigate the efficacy and safety of umbilical cord mesenchymal stem cells in the treatment of hepatitis B cirrhosis (compensatory stage). The subjects were randomly divided into two groups: umbilical cord mesenchymal stem cells injected through peripheral vein group and control group, with 10 cases in each group, a total of 20 cases. The subjects were randomly divided into two groups, namely, umbilical cord mesenchymal stem cells injected through peripheral vein group and control group. Patients in the treatment group were treated with stem cells based on conventional medical treatment. The efficacy and adverse reactions of patients were observed in detail within 24 weeks after treatment, and the long-term effect of stem cell therapy was observed after 96 weeks of treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Renmin Hospital of Wuhan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The age is between 18 and 65 years old (including 18 and 65 years old), regardless of gender;
  • The hardness of liver was detected by transient elastography, and liver cells were detected by imaging and laboratory examination There were no severe complications such as esophageal varices bleeding, ascites, or hepatic encephalopathy;
  • Plasma albumin ≥ 35g / L, total bilirubin < 35μThe activity of prothrombin was more than 60%, The child Pugh score was Grade A;
  • Willing to participate in this clinical study, will cooperate with doctors to carry out research, and sign informed consent.

Exclusion Criteria:

  • Spontaneous peritonitis or other severe infections were found;
  • Patients with hepatorenal syndrome;
  • Severe hepatic encephalopathy, massive hemorrhage of digestive tract or variceal hemorrhage occurred;
  • Combined with serious heart, lung, kidney, blood, endocrine system diseases; There were portal vein thrombosis;
  • Patients with positive serum HIV antibody;
  • The etiology of liver cirrhosis is not chronic HBV infection (HCV, EBV, CMC, autoimmune liver disease, primary biliary cirrhosis, parasitic, alcoholic, drug-related, genetic metabolic, genetic metabolic diseases), or other factors besides chronic HBV infection;
  • Malignant tumor of liver or other organs;
  • Pregnant women, lactating women, or those with recent birth planning;
  • Those who have a history of alcoholism and drug abuse and fail to give up effectively;
  • Participated in other clinical trials within 3 months before enrollment;
  • Participated in stem cell clinical research before;
  • Not willing to sign informed consent form;
  • Those who have neurological or mental disorders and are unable to cooperate or are unwilling to cooperate;
  • Other situations in which the researcher considered that the patient should not participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental
MSCs Participants will receive antiviral drug, anti-fibrotic drugs and UC-MSCs
Biological: UC-MSCs

Usage: The stem cell preparation in this study is used intravenously in the elbow.

Dose: The dose of stem cell injection in this clinical study is set at 1×10^6/Kg/time per injection Duration: 5 injections per trial group for the entire duration of the course, at 1st treatment, 2-week, 4-week, 16-week, and 24-week respectively
Placebo Comparator: Comparator
Comparator participants will receive antiviral drug, anti-fibrotic drugs and saline solution
Biological: Saline solution
Usage: The saline solution in this study is used intravenously in the elbow. Dose: The dose of saline solution in this clinical study is set at 250ml/time per injection Duration: 5 injections per person for the entire duration of the course, at 1st treatment, 2-week, 4-week, 16-week, and 24-week respectively

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
FibroScan
Time Frame: Change from Baseline Liver stiffness at week 24
Parameters of liver stiffness
Change from Baseline Liver stiffness at week 24
IV-C
Time Frame: Change from Baseline at week 24
Change of Serum hepatic fibrosis indexes
Change from Baseline at week 24
HA
Time Frame: Change from Baseline at week 24
Change of Serum hepatic fibrosis indexes
Change from Baseline at week 24
LN
Time Frame: Change from Baseline at week 24
Change of Serum hepatic fibrosis indexes
Change from Baseline at week 24
PC-III
Time Frame: Change from Baseline at week 24
Change of Serum hepatic fibrosis indexes
Change from Baseline at week 24
Hepatic histopathologic examination
Time Frame: Change from Baseline at week 24
Status of the liver
Change from Baseline at week 24
IgG
Time Frame: Change from Baseline at week 24
Change of humoral immunity
Change from Baseline at week 24
IgA
Time Frame: Change from Baseline at week 24
Change of humoral immunity
Change from Baseline at week 24
IgM
Time Frame: Change from Baseline at week 24
Change of humoral immunity
Change from Baseline at week 24
IgE
Time Frame: Change from Baseline at week 24
Change of humoral immunity
Change from Baseline at week 24
C3
Time Frame: Change from Baseline at week 24
Change of humoral immunity
Change from Baseline at week 24
C4
Time Frame: Change from Baseline at week 24
Change of humoral immunity
Change from Baseline at week 24
CD3
Time Frame: Change from Baseline at week 24
Change of cellular immunity
Change from Baseline at week 24
CD4
Time Frame: Change from Baseline at week 24
Change of cellular immunity
Change from Baseline at week 24
CD8
Time Frame: Change from Baseline at week 24
Change of cellular immunity
Change from Baseline at week 24
CD19
Time Frame: Change from Baseline at week 24
Change of cellular immunity
Change from Baseline at week 24
CD16+56
Time Frame: Change from Baseline at week 24
Change of cellular immunity
Change from Baseline at week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ALB
Time Frame: Change from Baseline at week 24
Change of Liver function
Change from Baseline at week 24
ALT
Time Frame: Change from Baseline at week 24
Change of Liver function
Change from Baseline at week 24
AST
Time Frame: Change from Baseline at week 24
Change of Liver function
Change from Baseline at week 24
TBIL
Time Frame: Change from Baseline at week 24
Change of Liver function
Change from Baseline at week 24
DBIL
Time Frame: Change from Baseline at week 24
Change of Liver function
Change from Baseline at week 24
HBV-DNA
Time Frame: Change from Baseline at week 24
Status of HBV infection
Change from Baseline at week 24
Change of ultrasound examination of liver
Time Frame: Change from Baseline at week 24
Status of the liver
Change from Baseline at week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Renmin Hospital of Wuhan University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
VCANBIO Cell & Gene Engineering Corporation, Ltd
Wuhan Optics Valley Zhongyuan Pharmaceutical Co., Ltd., Hubei, China

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: YINGAN JIANG, Renmin Hospital of Wuhan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 20, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RenminHJiangYingan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

After approval from the steering committee and the Human Genetic Resources Administration of China, this trial data can be shared with qualifying researchers who submit a proposal with a valuable research question. A contract should besigned.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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