Phase 1 Study of Autologous Bone Marrow Mononuclear Cells Infusion in Peripheral Vein in Liver Cirrhosis Due to Hepatitis C Virus
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Liver Cirrhosis Due to Virus C Chronic Hepatitis
- Sponsor
- Universidade Federal do Rio de Janeiro
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Liver function worsening
- Last Updated
- 17 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Chronic virus C hepatitis
- •Liver cirrhosis
- •Moderate liver disfunction
Exclusion Criteria
- •Malignant disease
- •Pregnancy
- •Significant comorbidity
- •Portal vein thrombosis
Outcomes
Primary Outcomes
Liver function worsening
Time Frame: One year
Secondary Outcomes
- Liver related mortality(One year)
- Hepatocellular carcinoma development accessed by ultrasound and CT scan(One year)
- BMMC kinetics accessed by total body scintigraphy(24 hours)
- Liver tissue changes evaluated by histopathology analysis and molecular biology(10 weeks)