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临床试验/JPRN-UMIN000028965
JPRN-UMIN000028965已完成1 期

Transhepatic arterial administration of G-CSF mobilized autologous peripheral blood CD34 positive cells in patients with hepatitis C virus-related liver cirrhosis - Transhepatic arterial administration of G-CSF mobilized autologous peripheral blood CD34 positive cells in patients with hepatitis C virus-related decompensated liver cirrhosis

Kurume University School of Medicine0 个研究点目标入组 24 人开始时间: 2017年9月20日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
24

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
20years-old 至 80years-old(—)
性别
All

入选标准

  • 未提供

排除标准

  • 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

研究者

发起方
Kurume University School of Medicine

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