Status:
TERMINATED
Safety Study of Autologous Stem Cell in Liver Cirrhosis
Lead Sponsor:
Universidade Federal do Rio de Janeiro
Collaborating Sponsors:
Financiadora de Estudos e Projetos
Conditions:
Liver Cirrhosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
It is a fase I/II clinical study to evaluate feasibility, safety and kinetics of cellular therapy with bone marrow-derived mononuclear cells (ABMMC) in patients with liver cirrhosis. All the patients ...
Detailed Description
A one year clinical trial was conducted. Patients had moderate liver dysfunction and a liver transplant was not expected to occur earlier than 12 months, due to low MELD scores. Hepatocellular carcino...
Eligibility Criteria
Inclusion
- Liver cirrhosis of any origin
- Moderate liver disfunction (Child-Pugh Score=7-10)
Exclusion
- Waiting time expectancy of liver transplant shorter than 12 months
- Ongoing hepatic encephalopathy
- Clinically detectable ascitis
- Severe coagulation disorder (INR\>2,0 or platelets count \< 40.000)
- Diagnosis or strong suspicion of cancer (except basocellular)
- Pregnancy or intention to become pregnant during the next 12 months
- Moderate or severe co-morbidity
- Current participation in another clinical trial
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00382278
Start Date
November 1 2005
End Date
February 1 2008
Last Update
April 3 2008
Active Locations (1)
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1
Hospital Universitário Clementino Fraga Filho
Rio de Janeiro, Rio de Janeiro, Brazil, 21941-590