SeaStar Medical and LMF Acquisition Opportunities have reported data from the SCD 005 clinical study of the use of SeaStar Medical’s Selective Cytopheretic Device (SCD) in treating Covid-19 patients suffering from multiple organ failure and admitted to the intensive care unit (ICU).
A cell-directed, patented, extracorporeal immunomodulator, the SCD has been designed to address hyperinflammation with selective targeting of activated neutrophils and monocytes.
The multi-centre pilot study has been designed to evaluate the SCD’s safety and efficacy in 22 Covid-19 patients either with acute kidney injury (AKI) or acute respiratory distress syndrome (ARDS).
The company stated that the SCD was integrated into a continuous renal replacement therapy (CRRT) blood circuit in the study.
During the study, patients were treated for up to 10 days, with a new SCD placed in the circuit every 24 hours or as required.
Reductions were observed in activated neutrophils and monocytes, which in turn led to a reduction in proinflammatory cytokines and improved clinical outcomes in patients.
SeaStar Medical said that subjects who received SCD treatment had a reduction in 60-day mortality to 50%, as against 81% in the control group.
The SCD-treated subjects who received more than 96 hours of treatment had a further reduction in mortality to 31% (p < 0.012).
SeaStar Medical president and CEO Eric Schlorff said: “Hyperinflammation can be a devastating factor for severe Covid patients who develop multi-organ complications.
“This pilot study helps inform our upcoming pivotal study, which will examine how our immunomodulatory therapeutic treatment can be disease-agnostic in its efforts to return a pro-inflammatory immune system back to a reparative state.”
The company also stated that the SCD treatment in Covid-19 ICU patients with multiple organ failure showed an acceptable safety profile, with no serious adverse events associated with the device.