Autologous Bone Marrow Mononuclear Cells in Liver Cirrhosis (CELTHEP-02)
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|ClinicalTrials.gov Identifier: NCT00832247|
Recruitment Status : Unknown
Verified January 2009 by Universidade Federal do Rio de Janeiro.
Recruitment status was: Recruiting
First Posted : January 30, 2009
Last Update Posted : January 30, 2009
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|
|Liver Cirrhosis Due to Virus C Chronic Hepatitis||Genetic: Autologous bone marrow mononuclear cells infusion||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||January 2009|
|Estimated Primary Completion Date :||April 2010|
|Estimated Study Completion Date :||April 2010|
Genetic: Autologous bone marrow mononuclear cells infusion
- Liver function worsening [ Time Frame: One year ]
- Liver related mortality [ Time Frame: One year ]
- Hepatocellular carcinoma development accessed by ultrasound and CT scan [ Time Frame: One year ]
- BMMC kinetics accessed by total body scintigraphy [ Time Frame: 24 hours ]
- Liver tissue changes evaluated by histopathology analysis and molecular biology [ Time Frame: 10 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00832247
|Contact: Guilherme FM Rezende, MD PhDfirstname.lastname@example.org|
|Contact: André Torres, MDemail@example.com|
|Hospital Universitário Clementino Fraga Filho||Recruiting|
|Rio de Janeiro, RJ, Brazil, 21914-913|
|Principal Investigator:||Guilherme FM Rezende, MD PhD||Universidade Federal do Rio de Janeiro|