Autologous Bone Marrow Mononuclear Cells in Liver Cirrhosis (CELTHEP-02)

Universidade Federal do Rio de Janeiro

Status and phase: Unknown; Phase 1

Conditions: Liver Cirrhosis Due to Virus C Chronic Hepatitis

Treatments: Genetic: Autologous bone marrow mononuclear cells infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT00832247

CELTHEP-02

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic virus C hepatitis
• Liver cirrhosis
• Moderate liver disfunction

Exclusion criteria

• Malignant disease
• Pregnancy
• Significant comorbidity
• Portal vein thrombosis

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)