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

Primary Purpose

Liver Cirrhosis Due to Virus C Chronic Hepatitis

Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Autologous bone marrow mononuclear cells infusion
Sponsored by
Universidade Federal do Rio de Janeiro
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis Due to Virus C Chronic Hepatitis focused on measuring Hepatitis C, Cirrhosis, Stem cell

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Hospital Universitário Clementino Fraga FilhoRecruiting

Outcomes

Primary Outcome Measures

Liver function worsening

Secondary Outcome Measures

Liver related mortality
Hepatocellular carcinoma development accessed by ultrasound and CT scan
BMMC kinetics accessed by total body scintigraphy
Liver tissue changes evaluated by histopathology analysis and molecular biology

Full Information

First Posted
January 29, 2009
Last Updated
January 29, 2009
Sponsor
Universidade Federal do Rio de Janeiro
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
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1. Study Identification

Unique Protocol Identification Number
NCT00832247
Brief Title
Autologous Bone Marrow Mononuclear Cells in Liver Cirrhosis
Acronym
CELTHEP-02
Official Title
Phase 1 Study of Autologous Bone Marrow Mononuclear Cells Infusion in Peripheral Vein in Liver Cirrhosis Due to Hepatitis C Virus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
April 2010 (Anticipated)
Study Completion Date
April 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Universidade Federal do Rio de Janeiro
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

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis Due to Virus C Chronic Hepatitis
Keywords
Hepatitis C, Cirrhosis, Stem cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Genetic
Intervention Name(s)
Autologous bone marrow mononuclear cells infusion
Intervention Description
At least 100.000.000 autologous BMMC will be infused in a peripheral vein once suspended in albumine during 10 minutes
Primary Outcome Measure Information:
Title
Liver function worsening
Time Frame
One year
Secondary Outcome Measure Information:
Title
Liver related mortality
Time Frame
One year
Title
Hepatocellular carcinoma development accessed by ultrasound and CT scan
Time Frame
One year
Title
BMMC kinetics accessed by total body scintigraphy
Time Frame
24 hours
Title
Liver tissue changes evaluated by histopathology analysis and molecular biology
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic virus C hepatitis Liver cirrhosis Moderate liver disfunction Exclusion Criteria: Malignant disease Pregnancy Significant comorbidity Portal vein thrombosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guilherme FM Rezende, MD PhD
Phone
55-21-99976292
Email
g.rezende@superig.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
André Torres, MD
Phone
55-21-78568495
Email
torres.alm@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guilherme FM Rezende, MD PhD
Organizational Affiliation
Universidade Federal do Rio de Janeiro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitário Clementino Fraga Filho
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21914-913
Country
Brazil
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Autologous Bone Marrow Mononuclear Cells in Liver Cirrhosis

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