Enrollment Begins in SeaStar Medical’s Study of its Selective Cytopheretic Device

SeaStar Medical Holding Corporation has enrolled the first patient in its NEUTRALIZE-AKI pivotal clinical trial to evaluate the safety and efficacy of its Selective Cytopheretic Device (SCD) extracorporeal therapy in critically ill adults with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT).
 
“We are delighted to enroll the first patient into our pivotal trial following the successful resolution of a supply-chain issue that temporarily impacted the sourcing of tubing connectors that are part of the SCD sets,” SeaStar Medical Chief Medical Officer Kevin Chung, M.D., said. “Nearly two dozen hospitals and academic centers have signed on to begin the process of onboarding as clinical trial sites. These sites are at various stages of activation with several anticipated to begin enrollment very soon.”
 
The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective CytopheretIic Device – a randomiZEd clinical trial in Acute Kidney Injury) pivotal trial is expected to enroll up to 200 patients. The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with SCD in addition to CKRT as the standard of care, compared with the control group receiving only CKRT standard of care. Secondary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at day 90 and dialysis dependency at one year. The study will also include subgroup analyses to explore the effectiveness of SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome. 

“We believe that reprogramming activated neutrophils and monocytes represents a major breakthrough for managing hyperinflammation in acute illness. Initiating trial enrollment is another important step in making the potentially lifesaving SCD therapy available to more than 200,000 U.S. adult patients each year with AKI who require CKRT as part of their standard of care,” SeaStar Medical CEO Eric Schlorff stated.
 
Hyperinflammation is the overproduction or overactivity of inflammatory cells that can lead to damage of vital organs. It occurs when the body overproduces inflammatory effector cells and other molecules that can be toxic, damaging to vital organs and result in multi-organ failure and even death. This is known as the cytokine storm. Unlike pathogen removal and other blood-purification tools, the SCD selectively targets the most highly activated proinflammatory neutrophils and monocytes. SeaStar Medical has observed that these most highly activated immune cells are turned off in a low calcium environment. Its patented SCD therapy mimics nature by creating a micro-environment, attracting these highly activated effector cells and neutralizing them in such an environment. These cells are then returned back into the body through the blood, and the body is signaled to focus on repair.
 
SeaStar Medical is redefining how extracorporeal therapies may reduce the consequences of excessive inflammation on vital organs. SeaStar Medical’s technologies rely on science to provide solutions to critically ill patients. The company is developing and commercializing cell-directed extracorporeal therapies that target the effector cells that drive systemic inflammation, causing direct tissue damage and secreting a range of pro-inflammatory cytokines that initiate and propagate imbalanced immune responses.