This project will validate the safety and efficacy of Corline Biomedical’s pharmaceutical compound Renaparin®, a novel cell replacement technology used to coat the lining of the blood vessels of kidneys prior to transplantation. Donor kidneys lack natural blood flow while awaiting transplantation. This can lead to ischemia (a shortage of oxygen and glucose supply to the kidney tissue). When connected to the recipient’s blood flow, this in turn leads to ischemia reperfusion injury (IRI). Given the alarming shortage of organs available for transplantation in the EU and internationally, the prevention of IRI has become a top priority for the transplantation community. Transplantation surgeons and nephrologists emphasise the pressing need for safe and effective technologies which can improve the outcome of kidney transplantation and extend donor criteria. Renaparin® is used when the kidney has been extracted from the donor and is stored in preservation solution awaiting transplantation. There, it binds to, replaces, repairs and protects damaged kidney cells on the endothelium of the vascular wall. As a result, a kidney is less likely to activate the host’s innate immune system, which increases the chances of organ survival and substantially reduces the likelihood of organ rejection. The research performed in preparation of further development of Renaparin® strongly supports the drug’s potential to increase the success of kidney transplantation. The activities proposed in this project will bring Renaparin® through a Phase I/IIa clinical trial in humans. The produced clinical safety data and preliminary clinical efficacy data will constitute the basis for further clinical development and commercialisation of the product. Corline’s strategic focus lies on establishing Renaparin® as a new cell replacement technology in kidney transplantation. This will constitute the cornerstone of Corline’s accelerated growth. The project is the key step to realize this strategy.