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Clinical Trials

SELICA III USA
SELICA = Safety and Efficacy of Liver Cell Application

Liver cell therapy has also been being studied in the USA since the onset of the SELICA III trial in 2010: The open, historically controlled, multicenter trial aims to demonstrate the safety and efficacy of liver cell therapy in children with a urea cycle defect.
Children aged 0 to 5 years that are suffering from ornithine transcarbamylase (OTC) deficiency, carbamoyl phosphate synthetase I (CPS I) deficiency or citrullinemia are being admitted to the trial. Five treatment centers and 10 centers that are actively recruiting patients and offering them continuing treatment are taking part in the SELICA III trial. The SELICA III clinical trial program was approved by the American regulatory body FDA (Food and Drug Administration) based on an analysis of interim results from the ongoing European SELICA V trial in neonates with urea cycle disorders.

SELICA V (formerly II) Europe
SELICA = Safety and Efficacy of Liver Cell Application

The European SELICA clinical trial program was initiated in 2008. The open, historically controlled, multicenter trial also aims to demonstrate the safety and efficacy of liver cell therapy in children with a urea cycle defect. Newborns, infants, and children up to the age of five that are suffering from a severe form of the following urea cycle defects can take part in the trial: ornithine transcarbamylase (OTC) deficiency, carbamoyl phosphate synthetase I (CPS I) deficiency or citrullinemia.