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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Dr. Sachin Jamadar, Chaitanya Hospital, Pune

Study Description
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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 .


Condition or disease Intervention/treatment Phase
Liver Cirrhosis Biological: Mesenchymal stem cell Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2013
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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 .


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Changes in liver function according to Child-Pugh [ Time Frame: 6 MONTH ]
  2. Changes in liver function according to MELD Score [ Time Frame: 6 MONTH ]
  3. Improvement in QUALITY OF LIFE SCALE (QOL) [ Time Frame: 6 month ]

Other Outcome Measures:
  1. Changes of any clinical symptoms like abdominal distension, appetite, debilitation [ Time Frame: 6 month ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Sachin P Jamadar, D.Ortho 918888788880 sac2751982@gmail.com
Contact: Smita S Bhoyar, B.A.M.S.PGCR 9372620569 drsmitabhoyar@rediff.com

Locations
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India
Chaitanya Hospital
Pune,, Maharashtra, India, 411009
Contact: Sachin P Jamadar, D ORTHO    +918888788880    sac2751982@gmail.com   
Contact: Smita S Bhoyar, BAMS.PGCR    9372620569    drsmitabhoyar@rediffmail.com   
Principal Investigator: Anant E Bagul, MS,Ortho         
Sponsors and Collaborators
Chaitanya Hospital, Pune
Investigators
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Principal Investigator: ANANT E BAGUL, MS ORTHO Chaitanya Hospital
More Information
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Responsible Party: Dr. Sachin Jamadar, Co -investigator, Chaitanya Hospital, Pune
ClinicalTrials.gov Identifier: NCT01877759    
Other Study ID Numbers: CSCC/BM/2013/LS/01
First Posted: June 14, 2013    Key Record Dates
Last Update Posted: October 9, 2013
Last Verified: October 2013
Keywords provided by Dr. Sachin Jamadar, Chaitanya Hospital, Pune:
Stem cell ,liver cirrhosis
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases