Stroke is serious life-threatening but unmet medical condition. It is the second leading cause of long-term disability in Europe and is the sixth leading cause worldwide. In the EU, the annual economic cost of stroke is an estimated €27 billion. Current stroke therapy is mainly based on general care and rehabilitation. 10-35% of stroke patients in Europe die within 28-30 days. Most strokes are caused by brain ischemia when blood vessel gets blocked, brain cells because of lack of oxygen get damaged and die. Microglia, brain immune cells, are the key cells initiating neuroinflammation in the injured brain area that evolves into amplifying brain inflammatory responses eventually leading to the secondary much worse brain damage.
Mesenchymal stromal cells (MSCs) are specific cells found in human umbilical cord that is usually discarded as medical waste. The cord tissues for this project were obtained from the 'Biobank Antwerpen' in Belgium, provided by the donors upon written informed consent. These cells can be isolated in the laboratory and secrete so called extracellular vesicles (MSC-EVs). The latter are very small, nano size biological particles containing many different types of therapeutically active molecules. During the last years, accumulating evidence show that MSC-EVs can stop brain inflammation and, on the top of that, start regeneration of already occurred brain damage in animal models. However, most of these studies produced MSC-EVs not according to the strict Good Manufacturing Practice (GMP) requirements applicable for medicinal drugs which is a must to be used on humans.
The Host of the project is Exo Biologics company located in Belgium, which is one of the pioneers in EVs field. The company has developed a proprietary and unique, fully GMP-compliant MSC-EVs production platform. Based on the mentioned state-of-the-art knowledge and unmet medical needs, MEXOM project's key aim was to develop and characterize at the Host’s laboratories an innovative MSC-EVs therapeutical product for treatment of stroke.
The key objectives of MEXOM project were successfully achieved. Firstly, a novel early-stage MSC-EVs drug candidate for stroke was developed, and its features were described. Secondly, its strong potential to inhibit brain inflammation was demonstrated in the laboratory. Eventually, a hypothesis how this drug works in stroke was formulated.