INDUSTRIAL PERSONALIZED TISSUE-ENGINEERING FOR THE REGENERATION OF ARTERIES

Important results from the project

There is a significant medical need for artery regeneration, and iPETRA aimed to make an advanced therapy product ready for clinical trials to provide a potential solution. The overall purpose of the project has been to make this new and unique technology ready for upcoming clinical trials and market approval. Process development, large animal studies, preparation for GMP production and preparation of regulatory documents have successfully been achieved. In other words, our project results lead towards entirely new medical and commercial opportunities for the future.

Expected long term effects

The iPETRA project has taken a novel advanced therapy product candidate through important preclinical and regulatory development steps. The most important result is positive in vivo safety data in a relevant disease model in large animals. At the same time, knowledge and expertise in this field has been built up and important partnerships and networks have been started. This network will be very valuable and will serve as a basis for continued research and development. The partners will continue to give Europe´s industry a prominent role in one of Life Science´s future areas.

Approach and implementation

iPETRA is a multi-task project where the partners have collectively performed as many key-steps as possible on the way from promising in vitro data through a complete set of preclinical activities, all in order to make the technology ready for commercial-scale up and clinical trials in the years to come. The commercial partner VERIGRAFT has covered process development and all documentary and commercial tasks together with partner Froceth, while RISE and SU have made the in vivo safety models possible.