A Parallel Group Randomized Open Blinded End Point Evaluation, Multicentric, Dose Escalation, Phase -II Study Assessing the Safety and Efficacy of Intraarterial (Hepatic) Ex-vivo Cultured Adult Allogenic Mesenchymal Stem Cells in Patients With Alcoholic Liver Cirrhosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 10
- 主要终点
- Safety
研究概览
简要总结
This study will evaluate the safety and efficacy of mesenchymal stem cells in patients with cirrhosis of liver. Stem cells will be injected into the hepatic artery. Improvement in various parameters will be observed over 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Alcoholic cirrhotics between 18-65 years of age (diagnosed by clinical, biochemical, sonographic, radiological [CT scan] or histological evidence of cirrhosis and portal hypertension).
- •Evidence of decompensated liver disease at screening (e.g. Child class B or C, Child-Pugh scores of ≥7 and <14).
- •MELD scores of at least 10 (UNOS Meld calculator).
- •Normal AFP Level
- •Hb>10gm/dl.
- •Female patients of childbearing age must be willing to use accepted methods of contraception during the course of the study
- •Signed informed consent.
排除标准
- •Patients likely to undergo liver transplantation during the duration of the study.
- •Presence of advanced hepatic encephalopathy Grades 3 & 4 (West Haven criteria for grading of hepatic encephalopathy) at the time of screening
- •Active variceal bleed.
- •Refractory ascites.
- •Evidences of autoimmune liver disease- ANA or Anti-LKM positivity.
- •Platelet count < 30,000/mm
- •Serum Sodium <129mEq/L.
- •Serum Creatinine > 2 mg/dl.
- •Hepatocellular carcinoma or other malignancies
- •Active infectious disease.
- •Presence of severe underlying cardiac, pulmonary or renal disease.
- •Excessive alcohol (>30 gm of alcohol/day) use in the last 3 months before screening.
- •Positive HbSAg or antibodies to HIV or HCV.
- •Pregnancy or lactation.
- •Participation in other clinical trials.
- •Unwilling/unable to sign the informed consent.
研究组 & 干预措施
Control
This arm will receive standard protocol of care alone
Stem cells low dose
This arm will receive low dose of Allogeneic Mesenchymal Stem Cells
干预措施: Allogeneic Mesenchymal Stem Cells (Biological)
Stem cells intermediate dose
This arm will receive intermediate dose of Allogeneic Mesenchymal Stem Cells
干预措施: Allogeneic Mesenchymal Stem Cells (Biological)
Stem cells high dose
This arm will receive high dose of Allogeneic Mesenchymal Stem Cells
干预措施: Allogeneic Mesenchymal Stem Cells (Biological)
结局指标
主要结局
Safety
时间窗: 2 years
The type of adverse events, number of adverse events and proportion of patients with adverse events
次要结局
- Histological evaluation of liver biopsy by immunohistochemical staining for AFP, PCNA, SMA(6 Months)
- Liver function tests.(2 years)
- CT scan of abdomen.(2 years)
- Change in MELD score(2 years)
- Improvement in quality of life as assessed by SF 36 questionnaire(2 years)
- Change in Child-Pugh score(2 years)