This study will evaluate the safety and efficacy of mesenchymal stem cells in patients with cirrhosis of liver. Stem cells will be injected into the hepatic artery. Improvement in various parameters will be observed over 2 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
High dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery
Intermediate dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery
Low dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery
Centre for Liver Research & Diagnostics
Hyderabad, Andhra Pradesh, India
Mediciti Hospital
Hyderabad, Andhra Pradesh, India
Manipal Hospital
Bangalore, Karnataka, India
KMC Hospital
Safety
The type of adverse events, number of adverse events and proportion of patients with adverse events
Time frame: 2 years
Liver function tests.
To assess the improvement in liver function
Time frame: 2 years
CT scan of abdomen.
To assess the improvement in liver structure
Time frame: 2 years
Change in MELD score
To assess the clinical improvement
Time frame: 2 years
Improvement in quality of life as assessed by SF 36 questionnaire
To assess the improvement in quality of life
Time frame: 2 years
Histological evaluation of liver biopsy by immunohistochemical staining for AFP, PCNA, SMA
To assess the improvement in histopathology
Time frame: 6 Months
Change in Child-Pugh score
To assess clinical improvement
Time frame: 2 years
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