Role of Bone Marrow Derived Autologous Stem Cells + Human Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Liver Cirrhosis
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Improvement in Liver function tests
研究概览
简要总结
Cirrhosis is caused by sustained liver damage over several years either by alcohol, viral infection (Hepatitis B, C), a toxic substance (for eg. drugs, excess copper or iron in the liver), or by blockage of biliary system such that the liver undergoes progressive scarring that slowly replaces all of normal liver cells.(LC) represents a late stage of progressive hepatic fibrosis characterized by distortion of the hepatic architecture and formation of regenerative nodules. For this condition of disease the liver transplantation is one of the only effective therapies available ,but due to lack of donors, surgical complications, rejection, and high cost are it's serious problems.
Presently stem cells are used to be a one of the treatment for the same. So our approach is to evaluate the safety and efficacy of mesenchymal stem cell in condition of liver cirrhosis .
详细描述
In this study, the patients with liver cirrhosis will undergo administration of human Mesenchymal stem cell MSCs intravenously for these patients.To observe the results Liver function will be monitored by serum analysis.The levels of serum alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT), prealbumin(PA) and albumin (ALB) will be examined at pre-transfusion, and 6th days to 1 years post-transfusion.Also the to see Improvement evaluation by MELD score ,Quality of life ,Child-Pugh score will be done .
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
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •25 -65 Ages Eligible for Study
- •Clinical diagnosis of liver cirrhosis
- •Ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the required Informed Consent Form (ICF) for the study.
- •Expecting lifetime is over three years
- •Ready to come all visits
排除标准
- •History of life threatening allergic or immune-mediated reaction
- •Positive test results for HIV and AIDS complex ,HCV , HbsAg and Syphilis
- •Malignancies
- •Vital organs failure
- •Pregnant or lactating women
- •Subject who has been transplanted recently
- •If the investigator or treating physician feels that the Subject with any disease or condition would interfere with the trial or the safety of patient
结局指标
主要结局
Improvement in Liver function tests
时间窗: 6 month
1) Improvement of Liver Function tests liver functions( Albumin (ALB), Alanine aminotransferase (ALT), Aspartate Aminotransferase (AST), Prealbumin(PA), total bilirubin (TB), and direct bilirubin (DB) kidney function Blood urea nitrogen (BUN), Urea (UA), and Crea (Cr)),international normalized ratio (INR) in Liver Cirrhosis Patients
次要结局
- Changes in liver function according to Child-Pugh(6 MONTH)
- Changes in liver function according to MELD Score(6 MONTH)
- Improvement in QUALITY OF LIFE SCALE (QOL)(6 month)
研究者
Dr. Sachin Jamadar
Co -investigator
Chaitanya Hospital, Pune