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

NCT05507762 | Unknown Phase 1

• 1 other identifier: RenminHJiangYingan
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cirrhosis Due to Hepatitis B

Keywords

cirrhosis; compensatory stage; human umbilical cord derived mesenchymal stem cells; Cirrhosis Due to Hepatitis B

Outcome Measures

Primary Outcomes (17)

• FibroScan

  Parameters of liver stiffness

  Change from Baseline Liver stiffness at week 24

• IV-C

  Change of Serum hepatic fibrosis indexes

  Change from Baseline at week 24

• HA

  Change of Serum hepatic fibrosis indexes

  Change from Baseline at week 24

• LN

  Change of Serum hepatic fibrosis indexes

  Change from Baseline at week 24

• PC-III

  Change of Serum hepatic fibrosis indexes

  Change from Baseline at week 24

• Hepatic histopathologic examination

  Status of the liver

  Change from Baseline at week 24

• IgG

  Change of humoral immunity

  Change from Baseline at week 24

• IgA

  Change of humoral immunity

  Change from Baseline at week 24

• IgM

  Change of humoral immunity

  Change from Baseline at week 24

• IgE

  Change of humoral immunity

  Change from Baseline at week 24

• C3

  Change of humoral immunity

  Change from Baseline at week 24

• C4

  Change of humoral immunity

  Change from Baseline at week 24

• CD3

  Change of cellular immunity

  Change from Baseline at week 24

• CD4

  Change of cellular immunity

  Change from Baseline at week 24

• CD8

  Change of cellular immunity

  Change from Baseline at week 24

• CD19

  Change of cellular immunity

  Change from Baseline at week 24

• CD16+56

  Change of cellular immunity

  Change from Baseline at week 24

Secondary Outcomes (7)

• ALB

  Change from Baseline at week 24

• ALT

  Change from Baseline at week 24

• AST

  Change from Baseline at week 24

• TBIL

  Change from Baseline at week 24

• DBIL

  Change from Baseline at week 24

Study Arms (2)

Experimental

EXPERIMENTAL

MSCs Participants will receive antiviral drug, anti-fibrotic drugs and UC-MSCs

Biological: UC-MSCs

Comparator

PLACEBO COMPARATOR

Comparator participants will receive antiviral drug, anti-fibrotic drugs and saline solution

Biological: Saline solution

Interventions

UC-MSCs BIOLOGICAL

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

Experimental

Saline solution BIOLOGICAL

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

Comparator

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Renmin Hospital of Wuhan University: lead
• Vcanbio Cell and Gene Engineering Corp., Ltd.: collaborator
• Wuhan Optics Valley Zhongyuan Pharmaceutical Co., Ltd., Hubei, China: collaborator

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Fibrosis

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• YINGAN JIANG

  Renmin Hospital of Wuhan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LICHAO YAO

CONTACT

+86 13638685006; ylc9409@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator, Clinical Professor

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 19, 2022
• Study Start: July 20, 2021
• Primary Completion: July 20, 2023
• Study Completion: August 20, 2023
• Last Updated: August 19, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)