Trial record 20 of 704 for:    "North American Indian childhood cirrhosis" OR "Liver Cirrhosis"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by Chaitanya Hospital, Pune
Sponsor:
Information provided by (Responsible Party):
Dr. Sachin Jamadar, Chaitanya Hospital, Pune
ClinicalTrials.gov Identifier:
NCT01877759
First received: June 12, 2013
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Liver Cirrhosis
Biological: Mesenchymal stem cell
Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Chaitanya Hospital, Pune:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • Changes of any clinical symptoms like abdominal distension, appetite, debilitation [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
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)
Arms Assigned Interventions
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 .

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 .

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01877759

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

Locations
India
Chaitanya Hospital Not yet recruiting
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
Principal Investigator: ANANT E BAGUL, MS ORTHO Chaitanya Hospital
  More Information

No publications provided

Responsible Party: Dr. Sachin Jamadar, Co -investigator, Chaitanya Hospital, Pune
ClinicalTrials.gov Identifier: NCT01877759     History of Changes
Other Study ID Numbers: CSCC/BM/2013/LS/01
Study First Received: June 12, 2013
Last Updated: October 8, 2013
Health Authority: India: Institutional Review Board

Keywords provided by Chaitanya Hospital, Pune:
Stem cell ,liver cirrhosis

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014