Phase 1 Study of Autologous Bone Marrow Mononuclear Cells Infusion in Peripheral Vein in Liver Cirrhosis Due to Hepatitis C Virus
Trial Snapshot
- Phase
- Phase 1
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Liver function worsening
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)