JPRN-jRCT2063200014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
Takami Taro0 个研究点目标入组 10 人开始时间: 2020年9月23日最近更新:
适应症
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
- >= 20age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •(1) Patients have the will and ability to provide consent form to participate in this clinical trial.
- •(2) Age: 20 to 75 years.
- •(3) Patients with liver cirrhosis confirmed by any of the following examinations
- •a. Liver biopsy
- •b. Imaging examination (abdominal ultrasound or CT examination or MRI examination), or FibroScan with result more than 12.5 kPa
- •(4) Child-Pugh score must be 7-12 points at 2 measurement points with 90 days or more interval.
- •(5) For female patients of childbearing potential, urine pregnancy test must be negative prior to study entry.
- •(6) Female patients of childbearing potential and male patients who have sex with fertile women must agree to use contraceptive method specified in the protocol.
- •(7) Patients must have the will and ability to visit hospital for examination at the time specified in the protocol
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 principle investigators or sub-investigators.
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