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

PT. Prodia Stem Cell Indonesia

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Liver Cirrhoses

Treatments: Biological: Allogeneic Umbilical Cord Mesenchymal Stem Cell

Study type: Interventional

Funder types: Industry

Identifiers

NCT04357600

CT/LC/01/2018

Details and patient eligibility

About

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

Full 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

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

intravenous injection of UC-MSC

Experimental group

Description:

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

Treatment:

Biological: Allogeneic Umbilical Cord Mesenchymal Stem Cell