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CELTHEP-02: Autologous Bone Marrow Mononuclear Cells in Liver Cirrhosis

Sponsor
Universidade Federal do Rio de Janeiro (Other)
Overall Status
Unknown status
CT.gov ID
NCT00832247
Collaborator
Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ) (Other), Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. (Other), Financiadora de Estudos e Projetos (Other), Oswaldo Cruz Foundation (Other), University of Edinburgh (Other)
15
Enrollment
1
Location
14.9
Duration (Months)
1
Patients Per Site Per Month

Study Details

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
  • Genetic: Autologous bone marrow mononuclear cells infusion
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
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 :
Jan 1, 2009
Anticipated Primary Completion Date :
Apr 1, 2010
Anticipated Study Completion Date :
Apr 1, 2010

Outcome Measures

Primary Outcome Measures

  1. Liver function worsening [One year]

Secondary Outcome Measures

  1. Liver related mortality [One year]

  2. Hepatocellular carcinoma development accessed by ultrasound and CT scan [One year]

  3. BMMC kinetics accessed by total body scintigraphy [24 hours]

  4. Liver tissue changes evaluated by histopathology analysis and molecular biology [10 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
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

Locations

Site City State Country Postal Code
1 Hospital Universitário Clementino Fraga Filho 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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00832247
Other Study ID Numbers:
  • CELTHEP-02
First Posted:
Jan 30, 2009
Last Update Posted:
Jan 30, 2009
Last Verified:
Jan 1, 2009
Keywords provided by , ,
Hepatitis C
Cirrhosis
Stem cell
Additional relevant MeSH terms:
Hepatitis A
Hepatitis C, Chronic
Hepatitis
Liver Cirrhosis
Fibrosis

Study Results

No Results Posted as of Jan 30, 2009