This is a phase I clinical study to evaluate feasibility, safety and kinetics of cellular therapy with autologous bone marrow-derived mononuclear cells (BMMC) in patients with liver cirrhosis due to virus C hepatitis. Another aim is to study liver tissue changes induced by the BMMC presence. All the patients have moderate liver disfunction and will be submitted to a liver biopsy before BMMC injection. The cells will be labeled with 99mTc and infused through a peripheral vein. Scintigraphy will be performed 24 hours after infusion. Patients will be submitted to frequent clinical, laboratorial and image evaluation during a one-year follow-up. A second liver biopsy will be done in the 3rd month after infusion to check histological, cellular and molecular evolutive changes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
At least 100.000.000 autologous BMMC will be infused in a peripheral vein once suspended in albumine during 10 minutes
Hospital Universitário Clementino Fraga Filho
Rio de Janeiro, Rio de Janeiro, Brazil
RECRUITINGLiver function worsening
Time frame: One year
Liver related mortality
Time frame: One year
Hepatocellular carcinoma development accessed by ultrasound and CT scan
Time frame: One year
BMMC kinetics accessed by total body scintigraphy
Time frame: 24 hours
Liver tissue changes evaluated by histopathology analysis and molecular biology
Time frame: 10 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.