Liver Cirrhosis Due to Virus C Chronic Hepatitis Clinical Trial
Official title:
Phase 1 Study of Autologous Bone Marrow Mononuclear Cells Infusion in Peripheral Vein in Liver Cirrhosis Due to Hepatitis C Virus
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.
n/a
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment