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

Phase 1

• Conditions: Liver Cirrhosis
• Interventions: Biological: Mesenchymal stem cell

• Registration Number: NCT01877759
• Lead Sponsor: Chaitanya Hospital, Pune

Brief Summary

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

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 .

Study Timeline

• Study First Submitted: 2013-06-12
• Study First Submitted QC: 2013-06-13
• Study First Posted: 2013-06-14
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-08
• Last Update Posted: 2013-10-09
• Study Start: 2013-12
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mesenchymal stem cell	Mesenchymal stem cell	hUMAN MESENCHYMAL STEM CELLS

Primary Outcome Measures

Name	Time	Method
Improvement in Liver function tests	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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chaitanya Hospital; 🇮🇳 Pune,, Maharashtra, India