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

November 29, 2023 updated by: Zhongnan Hospital

Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells for Treating Decompensated Liver Cirrhosis Associated With HBV

The purpose of this study was to observe the safety ,tolerability ,Efficacy dose of human umbilical cord mesenchymal stem cells in patients of decompensated liver cirrhosis with HBV.

Study Overview

Status

Status

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

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

Investigators plan to recruit 24 voluntary patients of decompensate liver cirrhosis with HBV, dividing them into 3 group：1) low-dose group: 100mL with 2.5×10^7 cells；2) medium-dose group: 100mL with 5.0×10^7 cells；3) high-dose group: 100mL with 1.0×10^8 cells. Each group contains 8 patients. Investigators treat the participants with human umbilical cord mesenchymal stem cells via venous transfusion. First investigators arrange a whole test for participants, such as vital sign examination, laboratory test, ECG, CT, MRI, ultrasound etc. Investigators screen these patients with a complete eligibility criteria. Then investigators proceed the therapy in the 1st, 8th and 15th day. There are 8 times of follow-up visit for these patients, 4 times of those are proceeded during the hospitalization, while other 4 times happens after the discharge. The follow-up visit includes vital sign examination, laboratory test, ECG, CT, MRI, ultrasound, Child-Pugh grade, MELD grade, SF-36 test. These follow-up visit last 24 weeks since the first treatment. After that, investigators also arrange a survival visit through phone or clinic each 6 months, lasting another 1.5 years. The main object of this research is investigating the survival rate, promotion of the liver function, improvement of health, safety of hUC-MSCs, tolerability of patients, for exploring a new way for the therapy of decompensated liver cirrhosis with HBV.

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 (Actual)

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.
24

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.
  • Early 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, 430000
        • Zhongnan Hospital of Wuhan University

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged between 18 and 65 (including 18 and 65), regardless of gender;
  • Decompensated stage of viral hepatitis B cirrhosis;
  • The effect of conventional medical treatment is not good, and the condition is repeated;
  • ALB < 35g/L, TBIL < 170μmol/L, INR > 30%, Child-pugh score ≥7; MELD score ≤15;
  • Hgb > 70g/L, PLT > 3×109/L;
  • Unconditional acceptance for liver transplantation; 7）Participate in the clinical study voluntarily, cooperate with doctors to carry out the study, and sign informed consent.

Exclusion Criteria:

  • With spontaneous peritonitis or other serious infection;
  • Patients with hepatorenal syndrome;
  • Severe hepatic encephalopathy, massive hemorrhage of digestive tract or varicose 4. vein in recent 1 month;
  • Portal vein thrombosis; Complicated with serious diseases of heart, lung, kidney,
  • blood and endocrine system;
  • HIV positive;
  • Positive autoantibodies related to autoimmune liver disease;
  • Presence of liver or any type of malignant tumor;
  • Pregnant women, breast-feeding women or those with recent birth plans;
  • Those who have a history of alcohol and drug abuse and failed to get rid of it effectively;
  • Participated in other clinical trials within 3 months prior to enrollment;
  • Participated in clinical research on stem cells;
  • Unwillingness to sign informed consent;
  • Other conditions that the investigator considers inappropriate for patients to participate in this 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: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

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: Low-dose group
100mL human umbilical cord mesenchymal stem cell preparation, containing 2.5×10^7 cells.
Biological: hUCMSCs
Human umbilical cord mesenchymal stem cell preparation, 100ml/ bag, containing 2.5×107 cells, 5.0×107 cells, 1.0 x 108 cells
Experimental: medium-dose group
100mL human umbilical cord mesenchymal stem cell preparation, containing 5.0×10^7 cells.
Biological: hUCMSCs
Human umbilical cord mesenchymal stem cell preparation, 100ml/ bag, containing 2.5×107 cells, 5.0×107 cells, 1.0 x 108 cells
Experimental: High-dose group
100mL human umbilical cord mesenchymal stem cell preparation, containing 1.0×10^8 cells.
Biological: hUCMSCs
Human umbilical cord mesenchymal stem cell preparation, 100ml/ bag, containing 2.5×107 cells, 5.0×107 cells, 1.0 x 108 cells

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
Serum albumin in g/L
Time Frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
24 weeks
alanine aminotransferase in U/L
Time Frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
24 weeks
aspartate aminotransferase in U/L
Time Frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
24 weeks
cholinesterase in U/L
Time Frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
24 weeks
Total bilirubin in μmol/L
Time Frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
24 weeks
Direct bilirubin in μmol/L
Time Frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
24 weeks
Serum cholesterol in mmol/L
Time Frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
24 weeks
Prothrombin activity in percentage
Time Frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
24 weeks
Antithrombin in mg/L
Time Frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
24 weeks

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
survival rate
Time Frame: 2 years
survival rate after 2 years since the first therapy
2 years
Child-Pugh grade
Time Frame: 24 weeks

Child-Pugh grade is defined according to hepatic encephalopathy, ascites，serum albumin, total bilirubin, prothrombin time. Score 5-6 is grade A. Score 7-9 is grade B. Score 10-15 is grade C.

We compare the Child-Pugh grade in first day, 4th, 8th, 12th and 24th week, to describe its tendency.
24 weeks
Rate of weight change
Time Frame: 24 weeks
We compare the weight in first day, 4th, 8th, 12th and 24th week, to describe its tendency.
24 weeks
Ascites
Time Frame: 24 weeks

We test the ascites via ultrasound, CT and MRI. We classify the ascite level into none, low and high.

We compare the Child-Pugh grade in first day, 4th, 8th, 12th and 24th week, to describe its tendency.
24 weeks
clinical symptoms
Time Frame: 24 weeks
Including lower limb edema, hematemesis, jaundice, fatigue, poor appetite. We compare these symptoms in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
24 weeks
Th1 cells in percentage
Time Frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
24 weeks
Th2 cells in percentage
Time Frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
24 weeks
Natural killer T cells in percentage
Time Frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
24 weeks
Interleukin-1β cells in pg/mL
Time Frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
24 weeks
Interleukin-4 cells in pg/mL
Time Frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
24 weeks
Interleukin-6 cells in pg/mL
Time Frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
24 weeks
Interleukin-8 cells in pg/mL
Time Frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
24 weeks
Interleukin-12 cells in pg/mL
Time Frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
24 weeks
Interleukin-15 cells in pg/mL
Time Frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
24 weeks
Interleukin-17A cells in pg/mL
Time Frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
24 weeks
Medical images
Time Frame: 24 weeks
Ultrasound in first day, 4th, 8th, 12th and 24th; enhanced CT scanning and/or MRI-Primovist scanning in first day, 12th week and 24th week.
24 weeks
The Medical outcomes study 36-item Short Form Health Survay scale (SF-36 scale)
Time Frame: 24 weeks
SF-36 scale is a measurement for patients' living quality. The scores contain 8 parts, including physical functioning, role-physica, bodily pain, general health, vitality, social functioning, role-emotional and mental health. Conversion score=(actual score-minimum score in this part)/(maximum score in this part-minimum score in this part)*100. Score of each part range from 0 to 100. The higher score means more healthy. We proceed SF-36 test in 12th week and 24th week
24 weeks
MELD score
Time Frame: 24 weeks
MELD=3.78*Ln(total bilirubin mg/dL)+11.2*Ln(INR)+9.57*Ln(serum creatine mg/dL)+6.43 (for HBV patient) We compare MELD score in first day, 4th, 8th, 12th and 24th week, to describe its tendency.
24 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 24 weeks
Including infusion reaction, anaphylaxis, hemolysis, acute liver failure, acute kidney failure. We observe whether participants shows these adverse event during the first whole 2 weeks and 4th, 8th, 12th and 24th weeks
24 weeks
Vital signs
Time Frame: 24 weeks
body temperature, pulse, respiration, blood pressure. We measure the vital signs in first day, 1st , 2nd, 3rd, 4th, 8th, 12th and 24th week.
24 weeks
Physical examination
Time Frame: 24 weeks
Including jaundice in skin or sclera, liver palms, spider angioma, abdominal tenderness, borborygms, shifting dullness. We proceed the physical examination in first day, 1st , 2nd, 3rd, 4th, 8th, 12th and 24th week.
24 weeks
Leukocyte in 10^9/L
Time Frame: 24 weeks
We test it in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
24 weeks
Hemoglobin in g/L
Time Frame: 24 weeks
We test it in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
24 weeks
Thrombocyte in 10^9/L
Time Frame: 24 weeks
We test it in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
24 weeks
Serum creatine in
Time Frame: 24 weeks
We test it in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
24 weeks
Serum creatine in μmol/L
Time Frame: 24 weeks
We test it in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
24 weeks
Serum urea nitrogen in mmol/L
Time Frame: 24 weeks
We test it in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
24 weeks
Alpha-fetoprotein in ng/mL
Time Frame: 24 weeks
We test it in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
24 weeks
Electrocardiogram of 12 leads
Time Frame: 24 weeks
Including lead I, II, III, AVL, AVF, AVR, V1 to V6. We record the diagnosis of the ECG, not a specific parameter. We test it in first day, 4th, 8th, 12th and 24th week.
24 weeks

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.
Zhongnan Hospital

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.
September 8, 2019

Primary Completion (Actual)

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 1, 2022

Study Completion (Actual)

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.
December 31, 2022

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).
April 13, 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.
June 27, 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.
July 5, 2022

Study Record Updates

Last Update Posted (Estimated)

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.
December 1, 2023

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.
November 29, 2023

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.
December 1, 2021

More Information

Terms related to this study

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.
  • 03

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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