NCT01877759

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 14, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

October 9, 2013

Status Verified

October 1, 2013

Enrollment Period

1 year

First QC Date

June 12, 2013

Last Update Submit

October 8, 2013

Conditions

Liver Cirrhosis

Keywords

Stem cell ,liver cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Improvement in Liver function tests

    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

    6 month

Secondary Outcomes (3)

  • Changes in liver function according to Child-Pugh

    6 MONTH

  • Changes in liver function according to MELD Score

    6 MONTH

  • Improvement in QUALITY OF LIFE SCALE (QOL)

    6 month

Other Outcomes (1)

  • Changes of any clinical symptoms like abdominal distension, appetite, debilitation

    6 month

Study Arms (1)

Mesenchymal stem cell

OTHER

hUMAN MESENCHYMAL STEM CELLS

Biological: Mesenchymal stem cell

Interventions

Mesenchymal stem cellBIOLOGICAL

Intravenous dose of Mesenchymal stem cell derived from human Bone Marrow \& umbilical cord , IN 6 divided doses , at interval of 1 week .

Mesenchymal stem cell

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chaitanya Hospital

Pune, Maharashtra, 411009, India

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • ANANT E BAGUL, MS ORTHO

    Chaitanya Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sachin P Jamadar, D.Ortho

CONTACT

918888788880sac2751982@gmail.com

Smita S Bhoyar, B.A.M.S.PGCR

CONTACT

9372620569drsmitabhoyar@rediff.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co -investigator

Study Record Dates

First Submitted

June 12, 2013

First Posted

June 14, 2013

Study Start

December 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

October 9, 2013

Record last verified: 2013-10

Locations

IN(1)