Umbilical Cord Mesenchymal Stem Cell for Liver Cirrhosis Patient Caused by Hepatitis B: Phase I/ II Study
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Examination of liver function
研究概览
简要总结
The study aims to evaluate the effect of allogeneic mesenchymal stem cell therapy on patients who suffered from liver cirrhosis caused by Hepatitis B.
详细描述
The study is investigating the effect and safety of stem cells therapy in patients with liver cirrhosis that is specifically caused by Hepatitis B infection, the participants will be chosen based on inclusive and exclusive criteria to ensure the eligibility of the patients for this study. The patients will be given therapy in the form of allogeneic mesenchymal stem cells transplantation, the stem cells in this study were provided from Prodia Stem Cell Indonesia (ProSTEM). The stem cells being will also be subjected to certain criteria to ensure the utmost safety. The data of this study will be derived from the observation results of the patients' liver damage status in weeks 4, 6 and 12. Aside from that, hemodynamic will be conducted as a part of the observation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with decompensated cirrhosis (Child-Pugh B) caused by hepatitis B infection (Cirrhosis is evidenced by the results of ultrasonography examination and chronic hepatitis B infection is found in patients who are taking hepatitis B drugs)
排除标准
- •Patients who refuse to participate in research
- •Having malignancies disease, both liver malignancies or other malignancies
- •Having another co-infections such as hepatitis C and Human Immunodeficiency Virus (HIV).
- •Pregnant or lactation patients as evidenced by positive pregnancy test results
- •Having complications disease such as diabetes mellitus, severe heart disease, kidney disease, and respiratory disease
- •Having the case of alcohol dependence and NASH
- •Patients who have undergone transplantation and other stem cell therapy
研究组 & 干预措施
intravenous injection of UC-MSC
The dosage of the intravenous route is 100 million MSCs for each subject.
干预措施: Allogeneic Umbilical Cord Mesenchymal Stem Cell (Biological)
结局指标
主要结局
Examination of liver function
时间窗: 6 months after injection
assessed from SGOT and SGPT values in laboratory tests result
Child Pugh Score
时间窗: 6 months after injection
a system for assessing the prognosis (including the required strength of treatment and necessity of liver transplant) of chronic liver disease, primarily cirrhosis. The score employs five clinical measures of liver disease.
MELD Score
时间窗: 6 months
a scoring system for assessing the severity of chronic liver disease. MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival.
Child Pugh Score
时间窗: 1 month after injection
a system for assessing the prognosis (including the required strength of treatment and necessity of liver transplant) of chronic liver disease, primarily cirrhosis. The score employs five clinical measures of liver disease.
Child Pugh Score
时间窗: 3 months after injection
a system for assessing the prognosis (including the required strength of treatment and necessity of liver transplant) of chronic liver disease, primarily cirrhosis. The score employs five clinical measures of liver disease.
Examination of liver function
时间窗: 1 month after injection
assessed from SGOT and SGPT values in laboratory tests result
Examination of liver function
时间窗: 3 months after injection
assessed from SGOT and SGPT values in laboratory tests result
MELD Score
时间窗: 1 month after injection
a scoring system for assessing the severity of chronic liver disease. MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival.
MELD Score
时间窗: 3 months after injection
a scoring system for assessing the severity of chronic liver disease. MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival.
次要结局
未报告次要终点