Autologous Bone Marrow Mononuclear Cells in Liver Cirrhosis
- Conditions
- Liver Cirrhosis Due to Virus C Chronic Hepatitis
- Registration Number
- NCT00832247
- Lead Sponsor
- Universidade Federal do Rio de Janeiro
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 15
- Chronic virus C hepatitis
- Liver cirrhosis
- Moderate liver disfunction
- Malignant disease
- Pregnancy
- Significant comorbidity
- Portal vein thrombosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Liver function worsening One year
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Hospital Universitário Clementino Fraga Filho
🇧🇷Rio de Janeiro, RJ, Brazil
Hospital Universitário Clementino Fraga Filho🇧🇷Rio de Janeiro, RJ, Brazil