A randomized, therapeutic exploratory clinical study to evaluate the safety and effectiveness of cell transplantation treatment using bone marrow-derived mesenchymal stem cells in patients with liver cirrhosis with ascites

Soon Chun Hyang University Hospital Seoul0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年3月4日

适应症

试验速览

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•1) Patients with liver cirrhosis above Child-Pugh score 7, with ascites
•2) Age of 19-70
•3) Patients who could be accessed to hepatic artery by catheterization
•4) In case of women, negative results for pregnancy test and planning to conduct contraception
•5) Patients who could follow the study guidelines
•6) Patients who agree to the informed consent

•1) Patients who were diagnosed for solid cancer in 5 years
•2) Patients who had transjugular intrahepatic portosystemic shunt
•3) Patients who had significant alcohol consumption (Men 210g/week, Women 140g/week) in 3 months or hepatotoxic agents in 6 months
•4) Patients with detection of hepatitis B virus or hepatitis C virus in the blood
•5) In the screening timepoint, patient who had high dose steroid (prednisolone above 10mg/day for longer than 7 days), antibiotics for severe infection, or immunosuppressants
•6) Paients who had significant traumatic history in 3 months
•7) In the screening timepoint, patients who had been diagnosed for the disease below
•- Severe aplastic anemia
•- History of liver transplantation
•- Active autoimmune hepatitis
•- Active viral hepatitis
•- Acute alcohol associated hepatitis
•- Extrehepatic biliary stricture
•- Heart failure or respiratory failure
•- Severe renal insufficiency
•- Acute or chronic infection which require systemic therapy
•8) Patients who had active portal vein thrombosis or hepatic vein thrombosis
•9) Patients who are not able to had bone marrow aspiration due to bone marrow diesease
•10) Pregnants or patient who are breastfeeding
•11) Patients who are not able to follow the study guidelines
•12) Patients who were subjects for the other clinical trials in 30 days
•13) Patients who had cell therapy before
•14) Patients who had complications which is judge by instructor

发起方

Soon Chun Hyang University Hospital Seoul