Phase I/II Trial of Allogeneic Umbilical Cord Mesenchymal Stem Cell Transplantation in Patients with Cirrhosis Due to Hepatitis B

Tahapan Penelitian : Recruit
Sponsor:
Mitra Pelaksana:
RSUPN Dr Cipto Mangunkusumo
No Registry
INA-2SF65XP7
Tanggal Input Registry : 30-05-2025

08-05-2018
Improvement is assessed based on the degree of liver function recovery, including liver function tests, Child-Pugh scores, and MELD scores.
 
Phase I/II Trial of Allogeneic Umbilical Cord Mesenchymal Stem Cell Transplantation in Patients with Cirrhosis Due to Hepatitis B
Phase I/II Trial of Allogeneic Umbilical Cord Mesenchymal Stem Cell Transplantation in Patients with Cirrhosis Due to Hepatitis B
Interventional
This study is a Phase I–II uncontrolled experimental trial investigating the effectiveness of allogeneic umbilical cord–derived mesenchymal stem cell transplantation in patients with cirrhosis due to chronic hepatitis B.
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Inclusion Criteria:

a) Patients aged 18–65 years b) Patients with decompensated cirrhosis (Child-Pugh B) due to hepatitis B infection: -Cirrhosis confirmed by ultrasonographic examination -Chronic hepatitis B infection indicated by ongoing antiviral treatment for hepatitis B

Exclusion Criteria:

a) Refusal to participate in the study b) Presence of malignancy, including liver or other types of cancer c) Co-infection with other diseases such as hepatitis C or Human Immunodeficiency Virus (HIV) d) Pregnant or lactating patients, confirmed by a positive pregnancy test e) Presence of complications such as diabetes mellitus, severe heart disease, kidney disease, or respiratory illness f) Cases of alcohol dependence or non-alcoholic steatohepatitis (NASH) g) Patients who have previously undergone transplantation or other stem cell therapies.
 
KET-0097/UN2.F1/ETIK/2018
Not applicable
Not applicable
Rima Haifa, S.Si, M. Farm-Klin