Liver Cirrhosis Due to Virus C Chronic Hepatitis
Conditions
Keywords
Hepatitis C, Cirrhosis, Stem cell
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.
Interventions
At least 100.000.000 autologous BMMC will be infused in a peripheral vein once suspended in albumine during 10 minutes
Sponsors
Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ)
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Financiadora de Estudos e Projetos
Oswaldo Cruz Foundation
University of Edinburgh
Universidade Federal do Rio de Janeiro
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Chronic virus C hepatitis * Liver cirrhosis * Moderate liver disfunction
Exclusion criteria
* Malignant disease * Pregnancy * Significant comorbidity * Portal vein thrombosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver function worsening | One year |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Brazil
Contacts
Primary ContactGuilherme FM Rezende, MD PhD
Backup ContactAndré Torres, MD
Outcome results
None listed