Fresenius Medical Care, the world’s largest provider of dialysis products and services, announced today that its subsidiary Unicyte AG has achieved a key preclinical milestone in its regenerative medicine program for chronic kidney disease. The company was able to confirm a disease modifying potential for its proprietary nano-Extracellular Vesicles (“nEVs” are stem cell-derived particles that support communication between cells) in a second preclinical model of chronic kidney disease.

When administered to mice with fast progressing kidney disease, Unicyte’s nEVs prevented renal fibrosis, a hallmark of chronic kidney disease. In particular, nEVs significantly reduced interstitial fibrosis and tubular necrosis while also inhibiting infiltration of various cells. This resulted in near-to-normal recovery of kidney function. The study conducted in collaboration with Prof. Giovanni Camussi of the University of Turin, Italy, has been accepted for publication in the peer-reviewed journal Frontiers of Immunology (https://doi.org/10.3389/fimmu.2018.01639).

These new results support previous findings in a preclinical model of slowly progressing kidney disease (diabetic nephropathy), a major pathology that often leads to end-stage renal disease. Combined results of these studies demonstrate the efficacy and the underlying mechanism of action of nEVs in preventing renal fibrosis and subsequent progression to end-stage renal disease. Unicyte will continue the preclinical and clinical development of its proprietary nEVs for treatment of chronic and acute kidney diseases.

Dr. Olaf Schermeier, Fresenius Medical Care’s CEO for Global Research and Development, said: “We are very excited about the progress we have made with our research and development activities over the last 30 months since we have established Unicyte. Based on these achievements, Unicyte will continue to explore the potential of nEVs for the treatment of patients in pre-dialysis stages of chronic kidney disease.”

Prof. Giovanni Camussi, Professor Emeritus at the University of Turin and Member of Unicyte’s Scientific Advisory Board, said, “nEVs are a promising regenerative medicine technology platform. Our aim is to develop new and better treatment options for severely and chronically ill patients over time. Achieving this preclinical milestone represents an important step towards testing nEVs in the clinical setting.”

With multiple therapeutic programs at the clinical and preclinical stage, Unicyte has established a broad pipeline in kidney and liver diseases, diabetes and oncology. The company is seeking strategic partnerships for its non-renal programs.