Heparesc

**Heparesc** is a cell therapy product consisting of cryopreserved mature human hepatocytes derived from ethically donated healthy livers. It is administered via infusion into the portal vein to provide functional liver cells that replace deficient hepatocytes in patients with urea cycle disorders, particularly neonatal onset citrullinaemia type 1 and other urea cycle disorders (UCDs). Developed initially by Cytonet GmbH & Co KG, it was acquired by Promethera Biosciences, which planned a New Drug Submission in Canada targeting early commercialization around 2017; however, the European Medicines Agency (EMA) refused marketing authorization in 2015 due to insufficient demonstration of efficacy and concerns over clinical trial data integrity from GCP inspections.[1][2][3][8]

Brand names

Heparesc

Other names

Human heterologous liver cells for infusion