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 Universidade Federal do 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
Oswaldo Cruz Foundation
University of Edinburgh
Information provided by:
Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT00832247
First received: January 29, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted

January 29, 2009
January 29, 2009
January 2009
April 2010   (final data collection date for primary outcome measure)
Liver function worsening [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Autologous Bone Marrow Mononuclear Cells in Liver Cirrhosis
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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Liver Cirrhosis Due to Virus C Chronic Hepatitis
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
April 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Malignant disease
  • Pregnancy
  • Significant comorbidity
  • Portal vein thrombosis
Both
18 Years to 75 Years
No
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
Brazil
 
NCT00832247
CELTHEP-02
Yes
Guilherme Ferreira da Motta Rezende, Federal UNiversity of Rio de Janeiro
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
Universidade Federal do Rio de Janeiro
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP