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Enrolling by invitation NCT04357600

Umbilical Cord Mesenchymal Stem Cell for Liver Cirrhosis Patient Caused by Hepatitis B

Phase I / Phase II Interventional Liver Cirrhoses

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Allogeneic Umbilical Cord Mesenchymal Stem Cell.
Who it may be relevant to
Registry conditions: Liver Cirrhoses. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Indonesia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Umbilical Cord Mesenchymal Stem Cell for Liver Cirrhosis Patient Caused by Hepatitis B: Phase I/ II Study

Overview

The study aims to evaluate the effect of allogeneic mesenchymal stem cell therapy on patients who suffered from liver cirrhosis caused by Hepatitis B.

Detailed description

The study is investigating the effect and safety of stem cells therapy in patients with liver cirrhosis that is specifically caused by Hepatitis B infection, the participants will be chosen based on inclusive and exclusive criteria to ensure the eligibility of the patients for this study. The patients will be given therapy in the form of allogeneic mesenchymal stem cells transplantation, the stem cells in this study were provided from Prodia Stem Cell Indonesia (ProSTEM). The stem cells being will also be subjected to certain criteria to ensure the utmost safety. The data of this study will be derived from the observation results of the patients' liver damage status in weeks 4, 6 and 12. Aside from that, hemodynamic will be conducted as a part of the observation

Interventions

  • Biological Allogeneic Umbilical Cord Mesenchymal Stem Cell
    All research samples will be treated by Intravenous injection of allogeneic mesenchymal stem cells and hemodynamic observation will be done for 24 hours after treated. Periodic post-treatment observation will be done on 1st month, 3rd month, and 6th month after therapy. The Independent variable in this research is Child-Pugh B Cirrhosis caused by Hepatitis B, while the dependent variable is the degree of liver function damage consisting of an examination of liver function, Child-Pugh score, and

Primary outcome measures

  • Child Pugh Score [Time frame: 1 month after injection]
  • Child Pugh Score [Time frame: 3 months after injection]
  • Child Pugh Score [Time frame: 6 months after injection]
  • Examination of liver function [Time frame: 1 month after injection]
  • Examination of liver function [Time frame: 3 months after injection]
  • Examination of liver function [Time frame: 6 months after injection]
  • MELD Score [Time frame: 1 month after injection]
  • MELD Score [Time frame: 3 months after injection]
  • MELD Score [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • Patients with decompensated cirrhosis (Child-Pugh B) caused by hepatitis B infection (Cirrhosis is evidenced by the results of ultrasonography examination and chronic hepatitis B infection is found in patients who are taking hepatitis B drugs)

Exclusion criteria

  • Patients who refuse to participate in research
  • Having malignancies disease, both liver malignancies or other malignancies
  • Having another co-infections such as hepatitis C and Human Immunodeficiency Virus (HIV).
  • Pregnant or lactation patients as evidenced by positive pregnancy test results
  • Having complications disease such as diabetes mellitus, severe heart disease, kidney disease, and respiratory disease
  • Having the case of alcohol dependence and NASH
  • Patients who have undergone transplantation and other stem cell therapy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Indonesia · 1 center
  • Cipto Mangunkusumo hospital — Jakarta

Identifiers

NCT: NCT04357600 · CT/LC/01/2018

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗