A Clinical Study to Evaluate the Safety and Efficacy of Mesenchymal Stem Cells in Liver Cirrhosis

Study Overview
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Brief Summary
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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 .

Detailed Description
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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 .

Official Title
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Role of Bone Marrow Derived Autologous Stem Cells + Human Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Liver Cirrhosis

Conditions
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Liver Cirrhosis

Intervention / Treatment
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* Biological: Mesenchymal stem cell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 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 Exclusion Criteria: History of life threatening allergic or immune-mediated reaction Positive test results for HIV and AIDS complex ,HCV , HbsAg and Syphilis Malignancies Sepsis 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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Mesenchymal stem cell<br>hUMAN MESENCHYMAL STEM CELLS | Biological: Mesenchymal stem cell<br>* Intravenous dose of Mesenchymal stem cell derived from human Bone Marrow & umbilical cord , IN 6 divided doses , at interval of 1 week .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Liver function tests | 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 | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stem cell ,liver cirrhosis