Cytonet Trials Aim to Better Assess Severity of Urea Cycle Disorders Using New Assay for Urea Production
HEIDELBERG, Germany, Feb. 14, 2012 /PRNewswire/ – International biotechnology firm Cytonet has launched a new clinical trial in Germany to compare the urea cycle activity of pediatric patients suffering from urea cycle disorders (UCD) to normal healthy children using an innovative assay to measure urea production. Researchers hope to provide a diagnostic tool to predict the severity of the urea cycle defect.
An ongoing clinical trial in the United States and Canada will also help determine if the assay can successfully measure patient outcomes after therapy. Cytonet’s ongoing SELICA III clinical trial, which is designed to evaluate the safety and efficacy of liver cell therapy in infants to children up to age 5 with UCD, includes the assay test of urea cycle activity as an endpoint. “In this trial, we have incorporated an assay to measure urea production and it will be used to monitor a patient’s ability to produce urea after liver cell infusion,” said Dr. Wolfgang Rudinger, CEO and CSO of Cytonet Germany. “Based upon the patient’s deficiency, it is anticipated that urea production before liver cell infusion would be negligible. An increase in urea production will be reflected as a correction of the deficiency and can be correlated to the presence of donor liver cells in the liver.”
“We hope that in future, this new test will allow us to improve our predictions on the severity of symptoms of patients with UCDs and thus optimize patients’ treatment,” said the lead investigator of the German trial, Georg Friedrich Hoffmann, M.D., Heidelberg University Hospital.
UCDs are congenital and often life-threatening disorders of ammonia metabolism in the liver. Neurotoxic ammonia accumulates in the body and may lead – depending on the severity of the disease – to massive damage of the nerves and the brain and can be fatal. Children who remain untreated rarely experience normal physical and mental development. The only cure is liver transplantation, which can be an extremely difficult procedure for very young children and neonatal patients. Additionally, there is a shortage of suitable organs available for transplantation.
SELICA III is currently enrolling patients at 14 sites in the United States and Canada. For more information, please visit Cytonetllc.com.
Cytonet is an internationally active biotechnology company which is located in Weinheim and Heidelberg in Germany and in Durham, NC in the U.S. The company develops and produces cell therapeutic products. Cytonet’s goal is to provide alternatives to existing therapies for many diseases with a particular emphasis on liver diseases. Cytonet is a pioneer and leader in the field of regenerative medicine. For the past several years, Cytonet has worked with internationally-leading metabolism and neonatal centers to study its liver cell therapy, which uses healthy and metabolically functional human liver cells collected from donated livers not suitable for transplant for infusion to treat urea cycle disorders in children. For more information, please visit Cytonet’s website at http://www.cytonetllc.com/
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