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Autologous Bone Marrow Mononuclear Cells in Liver Cirrhosis

NCT00832247 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2009-01-30

No results posted yet for this study

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.

Conditions

  • Liver Cirrhosis Due to Virus C Chronic Hepatitis

Interventions

GENETIC

Autologous bone marrow mononuclear cells infusion

At least 100.000.000 autologous BMMC will be infused in a peripheral vein once suspended in albumine during 10 minutes

Sponsors & Collaborators

  • Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ)

    collaborator UNKNOWN

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

    collaborator OTHER_GOV

  • Financiadora de Estudos e Projetos

    collaborator OTHER

  • Oswaldo Cruz Foundation

    collaborator OTHER

  • University of Edinburgh

    collaborator OTHER

  • Universidade Federal do Rio de Janeiro

    lead OTHER

Principal Investigators

  • Guilherme FM Rezende, MD PhD · Universidade Federal do Rio de Janeiro

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00832247 on ClinicalTrials.gov