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

Phase 1

• Conditions: Liver Cirrhoses
• Interventions: Biological: Allogeneic Umbilical Cord Mesenchymal Stem Cell

• Registration Number: NCT04357600
• Lead Sponsor: PT. Prodia Stem Cell Indonesia

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.

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 Timeline

• Study Start: 2018-05-17
• Study First Submitted: 2020-03-08
• Study First Submitted QC: 2020-04-21
• Study First Posted: 2020-04-22
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-12
• Last Update Posted: 2022-06-15
• Primary Completion: 2023-06-20
• Study Completion: 2023-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intravenous injection of UC-MSC	Allogeneic Umbilical Cord Mesenchymal Stem Cell	The dosage of the intravenous route is 100 million MSCs for each subject.

Primary Outcome Measures

Name	Time	Method
Examination of liver function	6 months after injection	assessed from SGOT and SGPT values in laboratory tests result
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.
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.

Trial Locations

Locations (1)

Cipto Mangunkusumo hospital; 🇮🇩 Jakarta, DKI Jakarta, Indonesia