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

Chaitanya Hospital, Pune

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Liver Cirrhosis

Treatments

Biological: Mesenchymal stem cell

Study type

Interventional

Funder types

Other

Identifiers

NCT01877759

CSCC/BM/2013/LS/01

Details and patient eligibility

About

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 .

Full 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 .

Enrollment

20 estimated patients

Sex

All

Ages

25 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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