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Clinical Trials

CCD05 USA
CCD = Cytonet Clinical Development

Liver cell therapy has also been being studied in the USA since the onset of the CCD05 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 CCD05  trial. The CCD05 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 CCD02 trial in neonates with urea cycle disorders.

CCD02 Europe
CCD = Cytonet Clinical Development

The European CCD 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.