Regenerative medicine to treat liver diseases

Interview with Prof. Etienne SOKAL, Head of Service at Cliniques universitaires Saint-Luc, Director of the Paediatric Unit at the Institute of Experimental and Clinical Research (IREC) of UCLouvain, Founder of Promethera Biosciences

Could you tell us how the Cliniques universitaires Saint-Luc contribute in the field of liver disease research? Recognised as pioneers in the treatment of liver diseases, Cliniques universitaires Saint-Luc performed the first ever liver transplant on a child in 1984. I myself specialised in liver diseases in children and we have developed an international care service activity for children suffering from such diseases, not only in the European Union but also in Eastern Europe, Russia, Ukraine and North Africa. My research work involved the discovery of innovative solutions for the diagnosis of liver diseases and the treatment of complications following liver transplantation.

The year 2000 marks a turning point in your work. Could you please expand on this? In that year I succeeded in developing the transplantation of hepatocytes, or liver cells. The proof of concept allowed me to validate the feasibility of inducing de novo enzymatic activity into a defective liver using this method.

Another significant discovery was made in 2005... Absolutely. That was the year in which we discovered with my colleague Mustapha Najimi a liver stem cell that is capable of differentiating into hepatocyte like cells and also has anti-inflammatory and anti-fibrotic properties. The first patients began to be treated at the Saint-Luc clinics. This discovery led to additional work to bring proof of concept for the solution of acquired liver diseases and to ensure the stem cell complies with the regulatory requirements in terms of safety and biodistribution.

It is just a small step from clinical innovation to entrepreneurship… I took that step in 2009. A twofold investment by Vesalius Biocapital and the Walloon Region allowed me to set up the Promethera Biosciences spin-off with the Louvain Technology Transfer Office (LTTO) of UCLouvain. I work on clinical development and research & development projects. The objective of Promethera Biosciences is to provide an alternative to liver transplantation. In 2011, the company launched its first clinical trials in metabolic diseases and, in 2016, in acquired acute and chronic liver failures (ACLF). The results of these trials were presented at congresses of scientific liver diseases associations in Europe (EASL) and in the United States (AASLD). Having demonstrated the safety and preliminary efficacy of the liver stem cell, and with its solid position with respect to intellectual property, Promethera Biosciences will be conducting confirmation clinical trials in ACLF and a comprehensive multi-centre study for this indication will be launched in early 2020. The company is also interested in the advanced stages of non-alcoholic steatohepatitis or NASH, also known as soda disease or fatty liver disease, and has preclinical data that also position its HepaStemTM product in this indication. Could you tell us about the international development of Promethera Biosciences? Promethera has also offices in Japan and in the United States, where it plans to conduct research in the same clinical indications. It also has a subsidiary in Durham, North Carolina (United States), where we will also be working on clinical developments. Together with our Belgian sites in Mont-Saint-Guibert and Gosselies, Promethera Biosciences has several branch offices employing a total of >140 highlty qualified. The guiding principle is invariably to provide an alternative to liver transplants, which are a major operation that not suited to every clinical situation. With the transplantation of liver stem cells, it is my hope that patients will soon have access to the benefits of regenerative medicine. © UCLouvain

© UCLouvain Expanding cell cultures for the treatment of hepatic patients with liver stem cells