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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Liver Cirrhoses

Intervention / Treatment
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* Biological: Allogeneic Umbilical Cord Mesenchymal Stem Cell


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The study model is considered as a single group assignment since all the participants are being administered with the same treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intravenous injection of UC-MSC<br>The dosage of the intravenous route is 100 million MSCs for each subject. | Biological: Allogeneic Umbilical Cord Mesenchymal Stem Cell<br>* 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 MELD score.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Pugh Score | a system for assessing the prognosis (including the required strength of treatment and necessity of liver transplant) of chronic liver disease, primarily cirrhosis. The score employs five clinical measures of liver disease. | 1 month after injection | 
| Child Pugh Score | a system for assessing the prognosis (including the required strength of treatment and necessity of liver transplant) of chronic liver disease, primarily cirrhosis. The score employs five clinical measures of liver disease. | 3 months after injection | 
| Child Pugh Score | a system for assessing the prognosis (including the required strength of treatment and necessity of liver transplant) of chronic liver disease, primarily cirrhosis. The score employs five clinical measures of liver disease. | 6 months after injection | 
| Examination of liver function | assessed from SGOT and SGPT values in laboratory tests result | 1 month after injection | 
| Examination of liver function | assessed from SGOT and SGPT values in laboratory tests result | 3 months after injection | 
| Examination of liver function | assessed from SGOT and SGPT values in laboratory tests result | 6 months after injection | 
| MELD Score | a scoring system for assessing the severity of chronic liver disease. MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival. | 1 month after injection | 
| MELD Score | a scoring system for assessing the severity of chronic liver disease. MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival. | 3 months after injection | 
| MELD Score | a scoring system for assessing the severity of chronic liver disease. MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allogeneic Mesenchymal Stem Cell, Umbilical Cord Mesenchymal Stem Cell, liver cirrhosis due to type B hepatitis