A Clinical Study to Evaluate the Safety and Efficacy of Mesenchymal Stem Cells in Liver Cirrhosis
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|ClinicalTrials.gov Identifier: NCT01877759|
Recruitment Status : Unknown
Verified October 2013 by Dr. Sachin Jamadar, Chaitanya Hospital, Pune.
Recruitment status was: Not yet recruiting
First Posted : June 14, 2013
Last Update Posted : October 9, 2013
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 .
|Condition or disease||Intervention/treatment||Phase|
|Liver Cirrhosis||Biological: Mesenchymal stem cell||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Role of Bone Marrow Derived Autologous Stem Cells + Human Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Liver Cirrhosis|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2014|
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 .
- Improvement in Liver function tests [ Time Frame: 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
- Changes in liver function according to Child-Pugh [ Time Frame: 6 MONTH ]
- Changes in liver function according to MELD Score [ Time Frame: 6 MONTH ]
- Improvement in QUALITY OF LIFE SCALE (QOL) [ Time Frame: 6 month ]
- Changes of any clinical symptoms like abdominal distension, appetite, debilitation [ Time Frame: 6 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|