Acute kidney injury (AKI) is a syndrome characterized by rapid loss of the kidney's excretory function. AKI is the leading cause of nephrology consultation and results in 17 million hospital admissions a year. The socioeconomic impact of AKI is significant, resulting in $10 billion cost to the health care system. Despite the high rate of incidence of AKI, no therapy currently exists, other than supportive care. Also, AKI occurs in up to 30% of all patients undergoing cardiac surgery. Despite advances in bypass techniques and intensive care, mortality and morbidity associated with AKI have not changed in the last decade. Furthermore, AKI represents a potential link to chronic kidney disease. Mesenchymal stem cell (MSC) therapies have shown promise in renal disease models; however, there are logistical barriers and potential safety concerns which will limit the usefulness of this therapy. We and others have shown the therapeutic potential of MSC secretome in ischemia/reperfusion (acute) kidney injury models. Here, we propose to assess the therapeutic effect of NFx-101 (our lead therapeutic agent) in the rat kidney ischemia/reperfusion injury model when infused before, immediately after, or 24-hours post injury as well as to evaluate the therapeutic effect of NFx-101 to prevent development of chronic kidney injury in a rat model of high salt induced kidney failure. As a result of this Phase I study we will establish the optimal NFx- 101 dose and regiment of treatment, which then will be used for Phase II study.
Project Terms: Acute; Acute Renal Failure with Renal Papillary Necrosis; Adipose tissue; Admission activity; Affect; Animals; Apoptotic; base; Biological Products; Bypass; Cardiac Surgery procedures; Cells; Chronic; Chronic Kidney Failure; Clinical; Clinical Trials; clinically relevant; Consultations; cost; Creatinine; Data; Development; Diet; Disease; Disease model; Disease Progression; Dose; drug candidate; Effectiveness; Engraftment; Excretory function; exosome; experimental study; Fibrosis; good laboratory practice; Health Care Costs; Healthcare Systems; Hospitals; Hour; human subject; immunoregulation; Incidence; Inflammation; Infusion procedures; Injections; Injury; Injury to Kidney; Intensive Care; Intervention; Intravenous; Investigational Drugs; Investigational New Drug Application; Ischemia; Ischemic Stroke; Kidney; Kidney Diseases; Kidney Failure; kidney vascular structure; Lead; Legal patent; Link; Logistics; Mediating; Mesenchymal Stem Cells; Modeling; Morbidity - disease rate; mortality; Nephrology; next generation; Nucleic Acids; Outcome; paracrine; Pathology; Pathway interactions; Patients; Phase; phase 1 study; phase 2 study; preclinical study; prevent; primary endpoint; Process; programs; prophylactic; Proteins; Rattus; Recovery; Regenerative Medicine; renal ischemia; repaired; Reperfusion Injury; Reperfusion Therapy; research clinical testing; Risk; Safety; safety study; secondary analysis; Serum; socioeconomics; Sodium Chloride; stem cell therapy; Stem cells; Supportive care; Syndrome; Techniques; Technology; Temperature; Testing; Therapeutic; Therapeutic Agents; Therapeutic Effect; Therapeutic Embolization; Time; Tissues; Toxic effect; Tumorigenicity; urinary;
