Clinical trial NCT01877759: A Clinical Study to Evaluate the Safety and Efficacy of Mesenchymal Stem Cells in Liver Cirrhosis
Official title: Role of Bone Marrow Derived Autologous Stem Cells + Human Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Liver Cirrhosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Liver Cirrhosis
Keywords: Stem cell ,liver cirrhosis
Lead sponsor: Chaitanya Hospital, Pune
Sponsor class: OTHER
First posted: 2013-06-14
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 .

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 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

Primary outcomes:
measure: Improvement in Liver function tests
timeFrame: 6 month
Secondary outcomes:
measure: Changes in liver function according to Child-Pugh
timeFrame: 6 MONTH
measure: Changes in liver function according to MELD Score
timeFrame: 6 MONTH
measure: Improvement in QUALITY OF LIFE SCALE (QOL)
timeFrame: 6 month
Other outcomes:
measure: Changes of any clinical symptoms like abdominal distension, appetite, debilitation
timeFrame: 6 month
Locations:
city: Pune,
country: India
facility: Chaitanya Hospital
state: Maharashtra
Study officials:
affiliation: Chaitanya Hospital
name: ANANT E BAGUL, MS ORTHO
role: PRINCIPAL_INVESTIGATOR
References: