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ENROLLING BY INVITATION
NCT04357600
PHASE1/PHASE2

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

Sponsor: PT. Prodia Stem Cell Indonesia

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2018-05-17

Completion Date

2028-12-20

Last Updated

2026-02-25

Healthy Volunteers

No

Conditions

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 MELD score.

Locations (1)

Cipto Mangunkusumo hospital

Jakarta, DKI Jakarta, Indonesia