Heparesc is Promethera’s most advanced pre-commercial product. The cell technology, which was one of the assets Promethera gained access to when it acquired Cytonet in 2015, is comprised of liver-derived primary, mature hepatocytes. Two clinical studies have successfully been completed and Promethera is preparing to file for market approval with the regulatory authorities in Canada in the first half of 2017.
Heparesc is a cell therapy product derived from donors that has been developed for the treatment of patients with urea cycle disorders. The product consists of a cryopreserved suspension of human liver cells, which are isolated from non-transplantable donor organs and prepared in a standardized manufacturing process under Good Manufacturing Practice conditions.
Heparesc for the treatment of Urea Cycle Disorder
Heparesc was developed for the treatment of deficient liver cell function in patients with inborn liver-based metabolic disorders such as urea cycle defects. In these medical conditions the patient may profit either from partial correction of the defect and /or in a “bridge to transplantation” setting from a transient functional support until a liver transplantation can be performed.
Stéphenne, Xavier, Mustapha Najimi, Catherine Sibille, Marie-Cécile Nassogne, Françoise Smets, and Etienne M Sokal. "Sustained Engraftment and Tissue Enzyme Activity After Liver Cell Transplantation for Argininosuccinate Lyase Deficiency." Gastroenterology 130, no. 4 (2006): doi:10.1053/j.gastro.2006.01.008