Decompensated liver cirrhosis (Hepatitis C virus-related)
Conditions
Interventions
G-CSF administration(5 days), Apheresis, Transhepatic arterial administration of CD34 positive cells
Standard medical therapy
Sponsors
Kurume University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with hepatitis C virus-related liver cirrhosis 2) Patients eligible for this study include those with hepatitis C virus-related decompensated liver cirrhosis with a Child-Pugh Score greater than or equal to 7 points in whom further improvement with current standard medical treatment is not expected at two points more than 90 days apart 3) Patients who aged 20 to 80 years 4) Patient who can give written informed consent themselves
Exclusion criteria
Exclusion criteria: 1) Patients with HCV-related liver cirrhosis or cryptogenic liver cirrhosis 2) Patients who are positive for HBs-Ag, HIV-Ab, HTLV1-Ab, serological test for syphilis and HBc-Ab (CLIA method >10.00 S/CO) 3) Patients with alcoholic drinkers, Patients with a Child-Pugh Score less than or equal to 6 points in whom further improvement with abstinence for more than 6 months. 4) Patients complicated of malignant tumor or patients with a history of malignant tumor within 5 years (However, for patients with a history of intraepithelial carcinoma [e.g., colon mucosal cancer] and hepatocellular carcinoma, which are negative for AFP and PIVKA-II, is not excluded) 5) Total bilirubin> 5.0 mg/dL 6) Prothrombin time less than 30% 7) Serum creatinine> 2.0 mg/dL 8) Hemoglobin less than 8 g/dL 9) Platelet less than 20,000 / uL 10) Patients who have splenomegaly with longitudinal spleen diameter more than 15 cm by abdominal CT 11) Patients who have gastrointestinal bleeding or patients who may cause bleeding in the gastrointestinal tract 12) Patients with portal vein thrombosis 13) Patients currently suffering from or having a history of interstitial pneumonia 14) Patients with hematological disease (leukemia, myeloproliferative disease, myelodysplastic syndrome or sickle cell anemia) 15) Patients with autoimmune disease 16) Patients with less than 3 months since last episode of unstable angina, myocardial/cerebral infarction, Patients with less than 3 months since coronary artery/carotid artery/intracranial artery stenting 17) Patients with proliferative diabetic retinopathy 18) Patients with a history of severe allergic reactions or side effects to G-CSF, apheresis, or a contrast agents 19) Pregnant women, lactating women, patients who may be pregnant, female patients planning pregnancy during the study period 20) Any other reason that the Clinical Supervision or Clinical Researchers may have for considering a case unsuitable for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-exacerbation rate of Child-Pugh score at 24 weeks after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Child-Pugh Score 2) MELD Score 3) Ascites by abdominal ultrasonography and abdominal CT 4) Serum albumin, total protein, total bilirubin value and PT-INR 5) Serum hyaluronic acid and type-IV collagen 6) QOL evaluation by SF-36v2 7) Portal blood flow and velocity by abdominal ultrasonography 8) Death due to liver cirrhosis and all deaths 9) Onset of hepatocellular carcinoma 10) Performance and bugs of magnetic cell separation device | — |
Countries
Japan
Contacts
Public ContactToru Nakamura
Kurume University School of Medicine Division of Gastroenterology, Department of Medicine
Outcome results
None listed