JPRN-jRCTb070190052已完成1 期
Transhepatic arterial administration of G-CSF mobilized autologous peripheral blood CD34 positive cells for patients with hepatitis C virus-related liver cirrhosis
akamura Toru0 个研究点目标入组 14 人开始时间: 2020年3月17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
- 14
研究概览
简要总结
The results of the current trial provide important insight into the safety, feasibility, and potential efficacy of G-CSF-mobilized autologous CD34+ cell therapy for patients with decompensated cirrhosis type C. Autologous PB-CD34+ cell infusion therapy may be a beneficial treatment for decompensated cirrhosis and may have the potential to reverse decompensated cirrhosis into compensated cirrhosis, thereby avoiding liver transplantation.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •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 (For patients who have received DAA treatment, take 2 points after 12 weeks have passed since the end of DAA treatment [or final medication if DAA treatment was stopped])
- •3) Patients who aged 20 to 80 years
- •4) Patient who can give written informed consent themselves
排除标准
- •1) Patients with HCV-related liver cirrhosis or cryptogenic liver cirrhosis
- •2) Patients complicated of malignant tumor or patients with a history of malignant tumor within 5 years (However, patients with a history of intraepithelial carcinoma [e.g. colon mucosal cancer] are not excluded if there is no recurrence; patients with a history of hepatocellular carcinoma, which are negative for AFP and PIVKA-II, are not excluded if there is no recurrence; patients with a history of hepatocellular carcinoma, which are positive for AFP or PIVKA-II, are not excluded if there is no recurrence at two points more than 3 months apart.)
- •3) Patients who have gastrointestinal bleeding or patients who may cause bleeding in the gastrointestinal tract
- •4) Patients with portal vein thrombosis (However, patients who do not affect the condition, such as wall thrombosis localized in a part of the portal vein, are not excluded.)
- •5) Patients with a history of severe allergic reactions or side effects to G-CSF, apheresis, or a contrast agents
- •6) History of hypersensitivity or drug reaction to mouse-derived proteins.
- •7) History of hypersensitivity or drug reaction to iron or iron dextran.
- •8) Patients who have splenomegaly with longitudinal spleen diameter more than 15 cm by abdominal CT
研究者
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