Abstract
Acute kidney injury continues to be a common and deadly condition despite medical advancements, occurring in upwards of half of all critically ill patients. Whether resulting from sepsis, the most common etiology, or from ischemic or nephrotoxic insults, acute kidney injury is associated with a systemic hyperinflammatory state that not only propagates additional kidney injury but often leads to injury of other organs as well. The Selective Cytopheretic Device is an autologous cell processing device that selectively targets and modifies the most inflammatory effector cells of the patients’ immune system to be in a less inflammatory state. As such, it is a novel approach to treating acute kidney injury by using cell-based rather than drug-based therapy with the aim of reducing inflammation, the causative factor of numerous disease states. Across multiple clinical trials, the selective cytopheretic device has demonstrated safety and efficacy as a treatment for acute kidney injury with reduced long term chronic dialysis sequelae, increased survival rates, and no device-related adverse events to date in both adult and pediatric populations. This innovative device has been granted FDA clearance under a Humanitarian Device Exemption to treat pediatric patients with sepsis associated acute kidney injury and its currently under evaluation in a pivotal trial in adults with renal injury as a step towards Pre-Market Approval. As the mechanism of action of the selective cytopheretic device lends it to be agnostic of the pathological cause, there is potential for it to be beneficial in treating other hyperinflammatory conditions as well.