Autologous Bone Marrow Mononuclear Cells in Liver Cirrhosis

NCT ID: NCT00832247

Last Updated: 2009-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Cirrhosis Due to Virus C Chronic Hepatitis

Keywords

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Hepatitis C Cirrhosis Stem cell

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Malignant disease
* Pregnancy
* Significant comorbidity
* Portal vein thrombosis
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ)

UNKNOWN

Sponsor Role collaborator

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role collaborator

Financiadora de Estudos e Projetos

OTHER

Sponsor Role collaborator

Oswaldo Cruz Foundation

OTHER

Sponsor Role collaborator

University of Edinburgh

OTHER

Sponsor Role collaborator

Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role lead

Responsible Party

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Federal UNiversity of Rio de Janeiro

Principal Investigators

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Guilherme FM Rezende, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio de Janeiro

Locations

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Hospital Universitário Clementino Fraga Filho

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Guilherme FM Rezende, MD PhD

Role: CONTACT

Phone: 55-21-99976292

Email: [email protected]

André Torres, MD

Role: CONTACT

Phone: 55-21-78568495

Email: [email protected]

Other Identifiers

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CELTHEP-02

Identifier Type: -

Identifier Source: org_study_id