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

January 29, 2009 updated by: Universidade Federal do Rio de Janeiro

Phase 1 Study of Autologous Bone Marrow Mononuclear Cells Infusion in Peripheral Vein in Liver Cirrhosis Due to Hepatitis C Virus

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RJ
      • Rio de Janeiro, RJ, Brazil, 21914-913
        • Recruiting
        • Hospital Universitario Clementino Fraga Filho

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Liver function worsening
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Liver related mortality
Time Frame: One year
One year
Hepatocellular carcinoma development accessed by ultrasound and CT scan
Time Frame: One year
One year
BMMC kinetics accessed by total body scintigraphy
Time Frame: 24 hours
24 hours
Liver tissue changes evaluated by histopathology analysis and molecular biology
Time Frame: 10 weeks
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Rio de Janeiro

Collaborators

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Oswaldo Cruz Foundation
Financiadora de Estudos e Projetos
University of Edinburgh
Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ)

Investigators

  • Principal Investigator: Guilherme FM Rezende, MD PhD, Universidade Federal do Rio de Janeiro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ANTICIPATED)

April 1, 2010

Study Completion (ANTICIPATED)

April 1, 2010

Study Registration Dates

First Submitted

January 29, 2009

First Submitted That Met QC Criteria

January 29, 2009

First Posted (ESTIMATE)

January 30, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 30, 2009

Last Update Submitted That Met QC Criteria

January 29, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CELTHEP-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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