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

Sponsor

PT. Prodia Stem Cell Indonesia (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04357600

Collaborator

(none)

Enrollment

Location

Arm

67.1

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Liver Cirrhoses	Biological: Allogeneic Umbilical Cord Mesenchymal Stem Cell	Phase 1/Phase 2

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

The study model is considered as a single group assignment since all the participants are being administered with the same treatment.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)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 17, 2018

Anticipated Primary Completion Date :

Jun 20, 2023

Anticipated Study Completion Date :

Dec 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: intravenous injection of UC-MSC The dosage of the intravenous route is 100 million MSCs for each subject.	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 MELD score.

Arm

Intervention/Treatment

Experimental: intravenous injection of UC-MSC

The dosage of the intravenous route is 100 million MSCs for each subject.

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 MELD score.

Outcome Measures

Primary Outcome Measures

Child Pugh Score [1 month after injection]
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.
Child Pugh Score [3 months after injection]
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.
Child Pugh Score [6 months after injection]
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.
Examination of liver function [1 month after injection]
assessed from SGOT and SGPT values in laboratory tests result
Examination of liver function [3 months after injection]
assessed from SGOT and SGPT values in laboratory tests result
Examination of liver function [6 months after injection]
assessed from SGOT and SGPT values in laboratory tests result
MELD Score [1 month after injection]
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.
MELD Score [3 months after injection]
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.
MELD Score [6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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