Autologous Bone Marrow Mononuclear Cells in Liver Cirrhosis
CELTHEP-02
Phase 1 Study of Autologous Bone Marrow Mononuclear Cells Infusion in Peripheral Vein in Liver Cirrhosis Due to Hepatitis C Virus
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 29, 2009
CompletedFirst Posted
Study publicly available on registry
January 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedJanuary 30, 2009
January 1, 2009
1.2 years
January 29, 2009
January 29, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Liver function worsening
One year
Secondary Outcomes (4)
Liver related mortality
One year
Hepatocellular carcinoma development accessed by ultrasound and CT scan
One year
BMMC kinetics accessed by total body scintigraphy
24 hours
Liver tissue changes evaluated by histopathology analysis and molecular biology
10 weeks
Interventions
At least 100.000.000 autologous BMMC will be infused in a peripheral vein once suspended in albumine during 10 minutes
Eligibility Criteria
You may qualify if:
- Chronic virus C hepatitis
- Liver cirrhosis
- Moderate liver disfunction
You may not qualify if:
- Malignant disease
- Pregnancy
- Significant comorbidity
- Portal vein thrombosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidade Federal do Rio de Janeirolead
- Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ)collaborator
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.collaborator
- Financiadora de Estudos e Projetoscollaborator
- Oswaldo Cruz Foundationcollaborator
- University of Edinburghcollaborator
Study Sites (1)
Hospital Universitário Clementino Fraga Filho
Rio de Janeiro, Rio de Janeiro, 21914-913, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guilherme FM Rezende, MD PhD
Universidade Federal do Rio de Janeiro
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 29, 2009
First Posted
January 30, 2009
Study Start
January 1, 2009
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
January 30, 2009
Record last verified: 2009-01