JPRN-UMIN000041461招募中1 期
An open-label, uncontrolled study to evaluate the efficacy and safety of autologous bone marrow mesenchymal stem cells (LS-ABMSC1) in patients with decompensated liver cirrhosis (Phase I / II study) - Study on the efficacy and safety of autologous bone marrow mesenchymal stem cells (LS-ABMSC1) in patients with decompensated liver cirrhosis
Yamaguchi University Graduate School of Medicine0 个研究点目标入组 10 人开始时间: 2020年8月31日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
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 75years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(1) Patients with a current history of malignant neoplasm (active neoplasm or recurrence within 1 year). However, carcinoma in situ or intramucosal cancer cured by local treatment are not included in active malignant neoplasms. (2) Patients with gastroesophageal varices at risk of rupture. (3) In patients with liver cirrhosis due to alcohol, alcohol consumption within 6 months before obtaining consent. (4) Hemoglobin <8 g/dL, platelet count <50,000/uL at screening. (5) Patients with hemorrhagic symptoms. (6) Patients with renal dysfunction (serum creatinine greater than or equal to 2 mg/dL) at screening. (7) Patients unable to obtain consent to allogeneic blood transfusion. (8) Infection with syphilis, HIV (human immunodeficiency virus), adult T-cell leukemia virus, and parvovirus B19 cannot be denied. (9) Women who have hope of pregnancy, or pregnant/lactating woman. (10) Inability to collect bone marrow fluid. (11) Inability to conduct abdominal angiography. (12) Inability to conduct local and venous anesthesia. (13) Patients with current or previous severe allergic reaction to any of the following. Contrast agents, DMSO, HES, heparin, gentamicin, human serum albumin, bovine and porcine derived components. (14) Administration of any of the following agents within 30 days before obtaining consent. - Albumin, warfarin, vitamin K, fresh frozen plasma (15) Change in the usage/dose of any of the following agents within 30 days before obtaining consent. - Branched-chain amino acid, diuretics, zinc preparation, carnitine, synthetic disaccharides, antibiotics for the treatment of hepatic encephalopathy (16) Conducted any of the following therapies within 30 days before obtaining consent. - Ascites puncture, CART, peritoneal-venous shunt (Denver shunt) (17) Patients who participate in other clinical trials, and patients who previously participated in this trial. (18) Any other patients judged to be inappropriate for study inclusion by investigators.
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