NCT01013194

Human Fetal Liver Cell Transplantation in Chronic Liver Failure

Human Fetal Liver Cell Transplantation for Treatment of Chronic Liver Failure

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The herein study consists in the transplantation of liver progenitor cells isolated from human fetal liver tissue with the aim of improving conventional liver therapy and broadening therapeutical options other than liver transplantation.

Detailed description

One of the major clinical problems in transplantation medicine is the discrepancy between the growing number of liver chronic disease patients and the lack of organs. Research and development of new liver failure treatments thus have a high clinical significance. Regenerative medicine and results recently achieved in the field of stem cell biology may provide a remedy to this emerging problem. Our project aims at developing new generation cell transplantation methodologies through an interdisciplinary research project created from a collaboration between ISMETT, Palermo and the University of Pittsburgh (UPMC-USA). Adult hepatocyte transplantation has been in use for several years already and has proved to be safe for patients and able, especially in pediatric patients, to improve liver function indices and delay the need for liver transplantation. Studies have been limited until now by the use of already differentiated hepatocytes and therefore unable to proliferate and develop a suitable liver mass to support a decompensated liver. The hypothesis of our project, supported by in vitro studies and studies on experimental animal models, is based on the possibility to generate an ectopic liver system in the spleen through the experimental use of hepatic cell progenitors obtained from human fetal liver tissues. Human fetal liver cell transplantation will be performed in the spleen through arterial injection. The final endpoint of the project is to develop an innovative and safe treatment for patients with end-stage chronic liver failure

Conditions

• Liver Cirrhosis

Interventions

Type	Name	Description
OTHER	Human Fetal Liver Cell Transplantation	Human Fetal Liver Cell Transplantation. Cell source: Non-purified and non-selected fetal liver cells from fetuses aborted between the 16th and 26th week of gestation. Infusion technique: Isolation and incannulation of the femoral artery.Splenic artery infusion under radiological guidance. Cell infusion: between 5 and 10x10\^8 cells. Number of sessions: up to 2.

Timeline

• Start date: 2007-02-01
• Primary completion: 2011-04-01
• Completion: 2011-07-01
• First posted: 2009-11-13
• Last updated: 2015-11-03
• Results posted: 2015-11-03

Locations

1 site across 1 country: Italy