NeuroFx, Inc. — Department of Health and Human Services STTR Phase I: 300

Description

ABSTRACT Acute kidney injuryAKIis a syndrome characterized by rapid loss of the kidneyandapos s excretory functionAKI is the leading cause of nephrology consultation and results inmillion hospital admissions a yearThe socioeconomic impact of AKI is significantresulting in $billion cost to the health care systemDespite the high rate of incidence of AKIno therapy currently existsother than supportive careAlsoAKI occurs in up toof all patients undergoing cardiac surgeryDespite advances in bypass techniques and intensive caremortality and morbidity associated with AKI have not changed in the last decadeFurthermoreAKI represents a potential link to chronic kidney diseaseMesenchymal stem cellMSCtherapies have shown promise in renal disease modelshoweverthere are logistical barriers and potential safety concerns which will limit the usefulness of this therapyWe and others have shown the therapeutic potential of MSC secretome in ischemia reperfusionacutekidney injury modelsHerewe propose to assess the therapeutic effect of NFxour lead therapeutic agentin the rat kidney ischemia reperfusion injury model when infused beforeimmediately afterorhours post injury as well as to evaluate the therapeutic effect of NFxto prevent development of chronic kidney injury in a rat model of high salt induced kidney failureAs a result of this Phase I study we will establish the optimal NFxdose and regiment of treatmentwhich then will be used for Phase II study NARRATIVE Acute kidney injurya syndrome characterized by the rapid loss of the kidneyandapos s excretory functionis the leading cause of nephrology consultationandmillion hospital admissions a yearresulting in health care costs of $billionand one of the major causes of development of chronic kidney diseaseUnfortunatelyAKI specific interventions beyond supportive therapy are currently not availableWe propose to develop a therapy based on therapeutic factors produced by stem cells that could potentially benefit the patients with acute kidney injury by reducing the damage of the functional tissue and vasculature of the kidneys