ISRCTN10368050已完成1 期
Macrophage therapy for liver cirrhosis
ACCORD (UK)0 个研究点目标入组 63 人开始时间: 2016年7月4日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
研究概览
简要总结
2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31591593 safety results (added 10/10/2019) 2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34750149/ (added 10/11/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age 17-65
- •2. Liver cirrhosis
- •3. Model for End-Stage Liver Disease (MELD) score 10-16
- •4. Aetiology liver disease: ALRD, NAFLD, PBC, hemochromatosis, alpha 1 anti trypsin deficiency, previous Hep C with SVR
排除标准
- •1. Refusal or inability to give informed consent to participate in the study
- •2. Other cause of chronic liver disease/cirrhosis not included in listed aetiologies – this is left to the clinical judgement of the investigator based on previous investigations and trial screening
- •3. Portal hypertensive bleeding; active episode of bleeding requiring hospitalisation in the last 3 months where varices have not been eradicated by banding
- •4. Ascites unless, in the opinion of the investigator, the ascites is minimal and well controlled with no increase to diuretic therapy in last 3 months
- •5. Encephalopathy; current or requiring hospitalisation for treatment in last 3 months
- •6. Hepatocellular carcinoma – uncertain cases to be discussed at local hepatobiliary multidisciplinary meeting, dysplastic or indeterminate nodules to be excluded, regenerative or other nodules to be included at discretion of MDM
- •7. Previous diagnosis of hepatocellular carcinoma
- •8. Previous organ transplant or previous recipient of tissue
- •9. Listed for liver transplantation
- •10. Any situation that in the Investigators' opinion may interfere with optimal study participation such as alcohol or drug abuse, domicile too distant from study site, potential non-compliance or inability to co-operate
- •11. Presence of clinically relevant acute illness that in the opinion of the investigator might compromise the participant’s safe participation in the study
- •12. Presence or history of cancer within past 5 years with exception of adequately treated localised skin carcinoma, in situ cervical cancer or solid malignancy surgically excised in total without recurrence for 5 years
- •13. Pregnancy or breastfeeding
研究者
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