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Milestones


2014

The European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) seeking  approval for Heparesc, vital human liver cells for the treatment of newborns and young children with inherited urea cycle defect (UCD). Validation of the MAA confirms that the submission is complete and begins the EMA’s Committee for Human Medicinal Products’ review process.


2013

Clinical trials extended – 13C-study CCD09, an open, multi-centric trial to evaluate a new biomarker of the urea cycle activity in-vivo, commenced at the beginning of 2012. With the help of this trial, we will now have the opportunity to develop the 13C-in-vitro-test as an indicator for the severity of urea cycle defects for patients


2012

After being granted approval by the German Federal Institute of Drugs and Medical Devices (BfArM), a clinical trial on the  diagnostics of urea cycle defects is being launched at Heidelberg University Hospital, led by Prof. Dr. med. Prof. h.c. (RCH) Georg Friedrich Hoffmann.

On July Cytonet received approval for the import, testing and batch release of somatic cell therapeutics for use in clinical trials according to § 72 Section 1 and § 13 Section 1 of the drug law


2011

The Canadian health authority, Health Canada, recently granted Cytonet approval to extend the CCD05 trial into Canada


2010

Start of collaboration between Cytonet, the Heidelberg University Pediatric Hospital and the Hamad-Medical-Center in Doha, Qatar

CCD trial extended to include the USA


2008

First successful treatment of a newborn with congenital urea cycle defect with liver cells.

The CCD02 study begins. Within the framework of the study, a new therapeutic option was offered to neonates with severe metabolic disorders of the liver, increasing their chances of survival.

Cytonet assumed ownership of the lease agreement of the production facilities of VESTA Therapeutics Inc., giving the company a US headquarters and production facility of its own in North America.


2007

Cytonet received the German Business Innovation Prize.


2006

Cytonet was the first company in the world to receive a production permit for a medicinal product based on human liver cells.

The European medicinal product authority EMEA recognized the Cytonet liver cell therapy as a medicinal product for use in the treatment of rare diseases (orphan drug).

Cytonet entered the US market by way of a cooperation with the company Vesta Therapeutics Inc. Liver cells for the Cytonet preparation were processed at the location of this US partner in Durham NC. t.


2004

Physicians succeed in saving the life of a female patient with a life-threatening acute liver failure using the Cytonet liver cell therapy.


2001

Cytonet was established as Germany’s leading company in the field of cell therapy, with production sites in Hanover and Heidelberg.

Dietmar Hopp, co-founder of SAP, invests in Cytonet. Dietmar Hopp and his family are now the majority shareholders.


2000

The Cytonet Group was founded as a spinoff from the cell therapy division of Roche Diagnostics GmbH.