NCT00832247

Autologous Bone Marrow Mononuclear Cells in Liver Cirrhosis

Phase 1 Study of Autologous Bone Marrow Mononuclear Cells Infusion in Peripheral Vein in Liver Cirrhosis Due to Hepatitis C Virus

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Universidade Federal do Rio de Janeiro · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Liver Cirrhosis Due to Virus C Chronic Hepatitis

Interventions

Type	Name	Description
GENETIC	Autologous bone marrow mononuclear cells infusion	At least 100.000.000 autologous BMMC will be infused in a peripheral vein once suspended in albumine during 10 minutes

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2009-01-30
• Last updated: 2009-01-30

Locations

1 site across 1 country: Brazil