Phase I/II Trial of Allogeneic Umbilical Cord Mesenchymal Stem Cell Transplantation in Patients with Cirrhosis Due to Hepatitis B
Tahapan Penelitian : Recruit
Sponsor:
PT Prodia StemCell Indonesia
Mitra Pelaksana:
RSUPN Dr Cipto Mangunkusumo
No Registry
INA-2SF65XP7
Tanggal Input Registry : 30-05-2025
Tracking Information | |
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Tanggal Antisipasi Studi | 08-05-2018 |
Outcome Primer | Improvement is assessed based on the degree of liver function recovery, including liver function tests, Child-Pugh scores, and MELD scores. |
Outcome Skunder | |
Descriptive Information | |
Judul Penelitian Popular | Phase I/II Trial of Allogeneic Umbilical Cord Mesenchymal Stem Cell Transplantation in Patients with Cirrhosis Due to Hepatitis B |
Judul Penelitian Ilmiah | Phase I/II Trial of Allogeneic Umbilical Cord Mesenchymal Stem Cell Transplantation in Patients with Cirrhosis Due to Hepatitis B |
Jenis Penelitian | Interventional |
Intervensi | 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. |
Jumlah Subyek Penelitian | 10 |
Recruitment Information | |
Eligibility Criteria | 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 BExclusion 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. |
Administrative Information | |
Nomor Persetujuan Etik | KET-0097/UN2.F1/ETIK/2018 |
Nomor Persetujuan Material Transfer Agreement | Not applicable |
Nomor Persetujuan Pelaksanaan Uji Klinik | Not applicable |
Other Study ID Numbers | |
Contact Person | Rima Haifa, S.Si, M. Farm-Klin |