SeaStar Medical recently completed enrollment of its SCD-005 clinical trial to demonstrate the safety of Selective Cytopheretic Device (SCD) in acute kidney injury (AKI) and acute respiratory distress syndrome (ARDS) with COVID-19 infection. This study builds on previous studies and further validates SCD's therapeutic approach, taking us one step closer to making the SCD a novel, significant device for critically ill patients.
The SCD extracorporeal therapeutic device sequesters neutrophils and monocytes, the cells that cause the inflammatory response, to resolve hyperinflammation and restore homeostasis. The cytopheretic intervention changes the natural course of the immune response allowing organs to stabilize and heal.
Completing enrollment is an important milestone on SeaStar Medical’s journey to establish the SCD as a new standard of care in addressing hyperinflammation. Hyperinflammation is a driver of organ dysfunction and damage as we have seen with COVID-19 patients. The SCD has the potential to stop hyperinflammation before it can cause lasting damage.
The SCD 005 study is an open-label, multi-center study to demonstrate the clinical activity safety and tolerability of the SCD among COVID-19 patients with AKI and/or ARDS. The primary endpoints include reducing mortality rates and dialysis dependency and increasing ventilation free survival. Findings are expected later this year.