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

NCT ID: NCT01877759

Last Updated: 2013-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-12-31

Brief Summary

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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 .

Detailed Description

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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 .

Conditions

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Liver Cirrhosis

Keywords

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Stem cell ,liver cirrhosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mesenchymal stem cell

hUMAN MESENCHYMAL STEM CELLS

Group Type OTHER

Mesenchymal stem cell

Intervention Type BIOLOGICAL

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

Interventions

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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 .

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chaitanya Hospital, Pune

OTHER

Sponsor Role lead

Responsible Party

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Dr. Sachin Jamadar

Co -investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ANANT E BAGUL, MS ORTHO

Role: PRINCIPAL_INVESTIGATOR

Chaitanya Hospital

Locations

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Chaitanya Hospital

Pune, Maharashtra, India

Site Status

Countries

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India

Central Contacts

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Sachin P Jamadar, D.Ortho

Role: CONTACT

Phone: 918888788880

Email: [email protected]

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

Role: CONTACT

Phone: 9372620569

Email: [email protected]

Facility Contacts

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Sachin P Jamadar, D ORTHO

Role: primary

Smita S Bhoyar, BAMS.PGCR

Role: backup

Other Identifiers

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CSCC/BM/2013/LS/01

Identifier Type: -

Identifier Source: org_study_id