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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Federal University of Rio de Janeiro.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
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 (FINEP)
Oswaldo Cruz Foundation
University of Edinburgh
Information provided by:
Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT00832247
First received: January 29, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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 Intervention Phase
Liver Cirrhosis Due to Virus C Chronic Hepatitis
 Genetic: Autologous bone marrow mononuclear cells infusion
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of Rio de Janeiro:

Primary Outcome Measures:
  • Liver function worsening [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Liver related mortality [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Hepatocellular carcinoma development accessed by ultrasound and CT scan [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • BMMC kinetics accessed by total body scintigraphy [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Liver tissue changes evaluated by histopathology analysis and molecular biology [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: January 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Malignant disease
  • Pregnancy
  • Significant comorbidity
  • Portal vein thrombosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832247

Contacts
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

Locations
Brazil
Hospital Universitário Clementino Fraga Filho Recruiting
Rio de Janeiro, RJ, Brazil, 21914-913
Sponsors and Collaborators
Federal University of 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 (FINEP)
Oswaldo Cruz Foundation
University of Edinburgh
Investigators
Principal Investigator: Guilherme FM Rezende, MD PhD Federal University of Rio de Janeiro
  More Information

No publications provided

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
Study First Received: January 29, 2009
Last Updated: January 29, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Rio de Janeiro:
Hepatitis C
Cirrhosis
Stem cell

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Liver Cirrhosis
Fibrosis
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

ClinicalTrials.gov processed this record on May 23, 2013