A Clinical Study to Evaluate the Safety and Efficacy of Mesenchymal Stem Cells in Liver Cirrhosis
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 .
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Role of Bone Marrow Derived Autologous Stem Cells + Human Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Liver Cirrhosis|
- Improvement in Liver function tests [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]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
- Changes in liver function according to Child-Pugh [ Time Frame: 6 MONTH ] [ Designated as safety issue: Yes ]
- Changes in liver function according to MELD Score [ Time Frame: 6 MONTH ] [ Designated as safety issue: Yes ]
- Improvement in QUALITY OF LIFE SCALE (QOL) [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
- Changes of any clinical symptoms like abdominal distension, appetite, debilitation [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Mesenchymal stem cell
hUMAN MESENCHYMAL STEM CELLS
Biological: Mesenchymal stem cell
Intravenous dose of Mesenchymal stem cell derived from human Bone Marrow & umbilical cord , IN 6 divided doses , at interval of 1 week .
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 .
Please refer to this study by its ClinicalTrials.gov identifier: NCT01877759
|Contact: Sachin P Jamadar, D.Orthoemail@example.com|
|Contact: Smita S Bhoyar, B.A.M.S.PGCRfirstname.lastname@example.org|
|Chaitanya Hospital||Not yet recruiting|
|Pune,, Maharashtra, India, 411009|
|Contact: Sachin P Jamadar, D ORTHO +918888788880 email@example.com|
|Contact: Smita S Bhoyar, BAMS.PGCR 9372620569 firstname.lastname@example.org|
|Principal Investigator: Anant E Bagul, MS,Ortho|
|Principal Investigator:||ANANT E BAGUL, MS ORTHO||Chaitanya Hospital|