Oslo University Hospital, IRW Consulting and NovaHep AB to prepare for and run clinical trial in Oslo
NovaHep AB has signed an agreement with Swedish contract research organisation IRW Consulting AB for an upcoming clinical trial in Oslo, Norway. Together with principal investigators at Oslo University Hospital, a first clinical trial using NovaHep´s personalised tissue-engineered vein (P-TEV) will be planned during 2015. This clinical trial, targeting the indication chronic venous insufficiency (CVI), is the first of its kind in the world and is sponsored by NovaHep. The P-TEV will be produced in a GMP accredited facility at Sahlgrenska University Hospital in Gothenburg for use by the National Unit for Reconstructive Deep Venous Surgery – Norwegian Venous Insufficiency (NOVI) at Oslo University Hospital, where the clinical trial will be performed. IRW Consulting will manage the study and will be responsible for monitoring, data management, pharmacovigilance and biostatistics. This study will be the first cornerstone in NovaHep’s portfolio of tissue-engineered products.
About NovaHep AB:
NovaHep AB is a Swedish regenerative medicine company with a unique technology for developing a broad range of biocompatible tissues and organs. NovaHep’s products in development rely on patient-individualisation of donated organs and tissues by applying advanced, proprietary stem cell technology. NovaHep has shown proof-of-concept with successful transplantations carried out at Sahlgrenska University Hospital in 2011 and 2012.
About IRW Consulting:
IRW is a Nordic Contract Research Organization (CRO) with more than 15 years of experience in conducting clinical trials, non-interventional Studies (NIS) and medical device investigations. IRW has offices throughout all Nordic countries, as well as an extensive network in the rest of Europe and the US.
About the National Unit for Reconstructive Deep Venous Surgery – Norwegian Venous Insufficiency (NOVI), Oslo University Hospital:
NOVI falls under the Department of Vascular Surgery at Oslo University hospital, which is a highly specialised hospital in charge of extensive regional and local hospital assignments and the provision of high quality services for the citizens of Oslo. The hospital also has a nationwide responsibility for a number of national and multi-regional assignments and has several national centres of competence. The hospital carries out advanced patient treatment, research and trial treatments, give advice and provide education on international levels. The hospital is Scandinavia’s largest, each year carrying out more than 1.2 million patient treatments (source: oslo-universitetssykehus.no).