Lately the Canadian health authority has given the Cytonet approval to extend the trial of SELICA III that began first in United States of America in 2010 and now it will be extended to Canada, the main aim of this trial is to make an evaluation concerning the safety and efficiency of liver cell therapy in the category of infant to children up to age 5 how have any type of disorder in the urea cycle(UCD).
The UCDs are disorders in the ammonia metabolism in the liver, which are usually a congenital disease and a life threatening disease more often. when Neurotoxic ammonia can accumulates in the body, it has the possibility of causing serious damage to the nerves and also to the brain and can be a main cause of death according to severe the disease is.
The two centers in Canada : (the Alberta Children’s Hospital in Calgary and the Hospital for Sick Kids in Toronto) joining the other 12 medical centers in the united states which are involved in the trial.
A doctor from CEO and CSO of Cytonet Germany, said that achieving their goal in this trail program, which is to include 20 child in their trail program, also to try to present the serious conditions new effective treating option in the time that there is only one cure which is liver transplantation, they need to add more centers in Canada to maintain this goal.
A general overview about SELICA (Safety and Efficacy of Liver Cell Application) Study
To make studies about liver cell treatment, Cytonet has a cooperative work for several years with international metabolism and neonatal centers, the Cytonet therapy uses healthy and metabolically functional human hepatocytes for infusion to treat the metabolism disorder. When obtaining healthy cells (which are maintained from U.S. organ procurement organizations) from donated livers and not suitable for transplant, these donated livers will be isolated and have complex processing, then they are infused into the hepatic portal vein over six days.
In July last year, the clinical testing was given the permission to complete with the trial testing in the SELICA III, also an analysis of a temporary results of currently going trial (SELICA V) in Germany which targets newborns with UCDs.
Finally the Cytonet has the honor to appreciate the assistance of the National Urea Cycle Disorders Foundation during the procession of this program.
