Adipose-Derived Stem Cells (ADSCs) Injections for Liver Cirrhosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- MELD
研究概览
简要总结
The aim of the investigators study was to investigate the safety and efficacy of autologous ADSCs for the clinical treatment of liver cirrhosis.
详细描述
One milliliter of cell suspension will be injected intrahepatically under sonographic guidance using a gauge-18 needle.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver cirrhosis investigators with age 20 to 80 years (both inclusive).
- •Investigators without Mandatory Communicable Disease (HBV, HCV, HIV, syphilis)
- •Investigators without rare disorder
- •Coagulation normalities
- •Investigators without autoimmune disorder
- •Investigators without Acquired Immune Deficiency Syndrome
- •Investigators without cancer
- •Investigators BMI > 15
排除标准
- •Pregnant women
- •Investigators with acute stroke in one month and unconsciousness
- •Investigators with acute myocardial infarction or acute heart failure
- •Investigators with serious liver dysfunction and coagulation dysfunction and ascites mild higher
- •Investigators with acute respiratory failure or pneumonia
- •Kidney Failure: BUN > 50
- •Anemia: Hematocrit < 25
- •Investigators diagnosed with liver cancer or liver metastatic carcinoma
- •Investigators with liver abscess
- •Investigators with acute Hepatitis
- •Investigators with acute infective
- •Liver cirrhosis patients with HBV or HCV
- •Investigators diagnosed with carcinoma and receiving treatment
- •Investigators with Schizophrenia or melancholia
- •Investigators received serious surgical operations in 3 months
- •Investigators unable to control hypertension (SBP > 180 mmHg, DBP > 110 mmHg) or diabetes (AC sugar > 200 mg/dl)
- •Others can't fit into the trial evaluate by investigator
研究组 & 干预措施
ADSCs
One milliliter of cell suspension will be injected intrahepatically under sonographic guidance using a gauge-18 needle.
干预措施: ADSCs (Drug)
结局指标
主要结局
MELD
时间窗: 1-6 month
MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival. It is calculated according to the following formula:MELD = 3.78\[Ln serum bilirubin (mg/dL)\] + 11.2\[Ln INR\] + 9.57\[Ln serum creatinine (mg/dL)\] + 6.43.
次要结局
未报告次要终点
研究者
Sabrina Huang
China Medical University Beigang Hospital
Gwo Xi Stem Cell Applied Technology Co., Ltd.