Human Fetal Liver Cell Transplantation in Chronic Liver Failure (hFLCTx)
|Liver Cirrhosis||Other: Human Fetal Liver Cell Transplantation||Phase 1 Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Human Fetal Liver Cell Transplantation for Treatment of Chronic Liver Failure|
- Patient Survival [ Time Frame: 1 year ]Assessment of treated and control patients survival at 1 year follow-up
- Analysis of Child-Pugh Score From Baseline to 1 Year Follow-up [ Time Frame: Baseline and 1 year Follow-up ]
Assessment of the efficacy of human fetal liver progenitor cell transplantation on Child-Pugh score.
The Child-Pugh (CP) classification is a scoring system used for the classification of the severity of cirrhosis. It includes three continuous variables (bilirubin, albumin and INR) and two discrete variables (ascites and encephalopathy). Each variable is scored 1-3 with 3 indicating most severe derangement. The determination of CP score may range from 5 to 15 and the final score allows to categorize patients in Child-Pugh A (5-6 points), B (7-9 points) and C (10-15 points). The highest is the score the sickest is the patient.
- Analysis of Meld Score From Baseline to 1 Year Follow-up [ Time Frame: Baseline and 1 year Follow-up ]
Assessment of the efficacy of human fetal liver progenitor cell transplantation on Meld score.
The Model for End-stage Liver Disease (MELD) scoring system aims at stratifying recipients by their disease severity according to a score estimating the 3-month probability of death on the waiting list. The calculation of an individual's MELD score is based on three objective lab parameters (bilirubin, serum creatinine and prothrombin time expressed as international normalized ratio, INR) and it includes logarithmic transformations and multiplication by several factors. It ranges between 6 and 40. The highest is the score the lower is the patient's survival.
|Study Start Date:||February 2007|
|Study Completion Date:||July 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Experimental: Treated patients
Cirrhotic patients treated with Human Fetal Liver Cell Transplantation.
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.
No Intervention: Control patients
Cirrhotic patients on Standard therapy.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01013194
|Palermo, Italy, 90127|
|Principal Investigator:||Bruno Gridelli, MD||ISMETT-UPMC|