Application of the Stem Cell Therapy in the End Stage Liver Disease and Assessment Its Consequences in the Quality of Live Style as Well as Development of HCC.
试验速览
- 阶段
- 不适用
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Incidence of hepatocellular carcinoma post stem cell therapy in hepatitis C virus infected patients
研究概览
简要总结
Prospective study to calculated the incidence of hepatocellular carcinoma in hepatitis C virus infected patients after stem cell therapy.
详细描述
Our prospective research is carried out in one of the stem cell therapy centers in Egypt where 140 hepatitis C virus infected patients attending for stem cell therapy are enrolled in our study and the patients will be followed up after stem cell therapy where the incidence of hepatocellular carcinoma after stem cell therapy will be calculated , another group of hepatitis C virus infected patients attending to Kasr El Aini university hospital to receive the standered line of care as indicated will be enrolled in our study and will be followed up , where the incidence of hepatocellular carcinoma will be calculated and compared to the previous group , to determine if there is a significant difference between both groups regarding the incidence of hepatocellular and determine whether stem cell therapy affecets the incidence of hepatocellular carcinoma in hepatitis C virus infected patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged from 20 to 65 years of age.
- •Evidence of chronic liver insufficiency.
- •The presence of decreased serum albumin and/or increased bilirubin and/or increased international normalized ratio (INR).
- •Patient is unlikely to receive a liver transplant.
- •Ability to give written consent
- •Women of childbearing potential may be included, but must use a reliable and appropriate contraceptive method
排除标准
- •Patients below the age of 20 or above the age of 65 years
- •Pregnant or lactating women
- •Patients with recent recurrent GI bleeding or spontaneous bacterial peritonitis
- •Patients with evidence of HIV or other life threatening infection
- •Patients unable to give informed consent
- •Patients with a history of hypersensitivity to G-CSF
- •Patients who have been included in any other clinical trial within the previous month
- •Patient with recurrent attacks of hepatic encephalopathy.
- •Evedince of portal vein thrombosis by ultrasound.
结局指标
主要结局
Incidence of hepatocellular carcinoma post stem cell therapy in hepatitis C virus infected patients
时间窗: within the first year after stem cell therapy
次要结局
- Compare the incidence of hepatocellular carcinoma in patients who had received stem cell therapy to those who had received the standared line of care(within one year of follow up of hepatitis C virus infected patients)