Hyperacute Serum (HAS) developed by OrthoSera company is an innovative serum-based blood product free of platelets, leukocytes, and fibrin. Hyperacute serum may be obtained as an autologous product, however, OrthoSera has established an innovative protocol for hyperacute serum preparation in allogeneic form, which includes the freezing-drying process as well as IgM and IgG antibody removal. Processed allogeneic blood-derived products donated by healthy, specially selected donors could be key for improving health in an aging population. The previous project aimed to develop the prototype of a point of care medical device called "hypACT-next", which is a combination of stabilized and aseptically produced hyperacute serum in a freeze-dried powder form and a sterilized hyaluronic acid liquid. It was possible to successfully implement an advanced prototype device in a laboratory scale, close to series production. For further development, it is necessary to perform biocompatibility testing, classification process and pre-clinical evaluation of the efficacy of "hypACT-next" in the target indication of knee osteoarthritis. This project aims to translate the laboratory work of the "hypACT-next" prototype development from bench to the bedside. Before switching to clinical study several steps still have to be completed. This translation is a complex process and will inlcude the market launch phase and pre - clinical development with 4 different in-vitro models, previously established by prof. Nehrer's reasearch group at the Danube University.
|Duration||01/01/2020 - 31/12/2021|
|Funding||Bundesländer (inkl. deren Stiftungen und Einrichtungen)|
|Principle investigator for the project (Danube University Krems)||Univ.-Prof Dr. Stefan Nehrer|