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

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ClinicalTrials.gov Identifier: NCT00832247
Recruitment Status : Unknown
Verified January 2009 by Universidade Federal do Rio de Janeiro.
Recruitment status was:  Recruiting
First Posted : January 30, 2009
Last Update Posted : January 30, 2009
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Due to Virus C Chronic Hepatitis Genetic: Autologous bone marrow mononuclear cells infusion Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Autologous Bone Marrow Mononuclear Cells Infusion in Peripheral Vein in Liver Cirrhosis Due to Hepatitis C Virus
Study Start Date : January 2009
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    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

Outcome Measures

Primary Outcome Measures :
  1. Liver function worsening [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Liver related mortality [ Time Frame: One year ]
  2. Hepatocellular carcinoma development accessed by ultrasound and CT scan [ Time Frame: One year ]
  3. BMMC kinetics accessed by total body scintigraphy [ Time Frame: 24 hours ]
  4. Liver tissue changes evaluated by histopathology analysis and molecular biology [ Time Frame: 10 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00832247

Contact: Guilherme FM Rezende, MD PhD 55-21-99976292 g.rezende@superig.com.br
Contact: André Torres, MD 55-21-78568495 torres.alm@gmail.com

Hospital Universitário Clementino Fraga Filho Recruiting
Rio de Janeiro, RJ, Brazil, 21914-913
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
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
Principal Investigator: Guilherme FM Rezende, MD PhD Universidade Federal do Rio de Janeiro
More Information

Responsible Party: Guilherme Ferreira da Motta Rezende, Federal UNiversity of Rio de Janeiro
ClinicalTrials.gov Identifier: NCT00832247     History of Changes
Other Study ID Numbers: CELTHEP-02
First Posted: January 30, 2009    Key Record Dates
Last Update Posted: January 30, 2009
Last Verified: January 2009

Keywords provided by Universidade Federal do Rio de Janeiro:
Hepatitis C
Stem cell

Additional relevant MeSH terms:
Hepatitis A
Hepatitis, Chronic
Liver Cirrhosis
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Pathologic Processes
Hepatitis C
Flaviviridae Infections