Results show promise for returning a dysregulated immune system to homeostasis in critically ill patients
DENVER, CO, November 5, 2021— SeaStar Medical, a medical device company that has redefined how extracorporeal therapies may reduce excessive inflammation on vital organs, announced new data from its SCD 005 clinical study to evaluate the safety and feasibility of the Selective Cytopheretic Device (SCD) in COVID-19 patients with acute kidney injury (AKI) and/or acute respiratory distress syndrome (ARDS). The data were presented at the American Society of Nephrology (ASN) Kidney Week 2021 Annual Meeting.
In the poster presentation, “SCD treatment in COVID-19 ICU Patients with Acute Respiratory Distress Syndrome (ARDS) and Acute Kidney Injury (AKI) is Safe and May Improve Clinical Outcomes,” researchers report how the SCD treatment provides an immunomodulatory and disease-agnostic effect in critically ill COVID-19 patients with AKI and ARDS, a therapeutic treatment that returns the immune system back toward homeostasis.
Mortality rates are high in intensive care patients with COVID-19 and AKI requiring CRRT and/or ARDS on mechanical ventilation. In this study of 22 patients, the SCD was integrated into the CRRT blood circuit with strictly controlled low ionized calcium concentration between 0.25 and 0.4 mmol/L achieved using regional citrate anticoagulation and calcium-free dialysate. Patients were treated for up to 10 days. The SCD was changed every 24 hours or as needed. Patients experienced reductions in activated neutrophils and monocytes, which led to reduction in proinflammatory cytokines and improved clinical outcomes. Based on a minimum of four days of therapy per protocol, the mortality of treated patients was significantly lower than the contemporaneous control population that was treated under the current standard of care. These findings suggest a favorable benefit-to-risk ratio in the patient population.
“The findings are an important step in validating the role of effector cells – neutrophils and monocytes – responsible for a dysregulated systemic inflammatory response. The SCD was able to remove the most activated neutrophils and monocytes from circulation, enabling a return to a regulated healing process,” said Dr. H. David Humes, professor of nephrology at University of Michigan, board member of SeaStar Medical and one of the lead investigators on the study.
Immune system dysregulation contributes to the severity of COVID-19, as demonstrated by abnormal levels of pro- and anti-inflammatory leukocytes (neutrophils and monocytes) and cytokines. The current standard of care for treatment of immune system dysfunction focuses on removing cytokines from circulation which has resulted in numerous inconsistent clinical outcomes or no impact on mortality.
The SCD’s unique mechanism of action sequesters critical effector cells driving the dysregulated systemic inflammatory state of COVID-19 infection. This contrasts from sorbent-based technologies to reduce blood cytokine levels or pathogen load.
There were no adverse events specific to the device or from the use of regional citrate anticoagulation and no leukopenia or thrombocytopenia reported. No clotting occurred in the SCD components.
“We are excited with the results of this trial. We exceeded our goals to improve health outcomes for critically ill patients. This pilot study lays the important groundwork for our upcoming pivotal trial,” said Eric Schlorff, CEO of SeaStar Medical.
The poster presentation for the ASN Kidney Week 2021 Meeting is available on the Meeting website.
About SeaStar Medical
Denver-based SeaStar Medical is a privately held medical technology company that has redefined how extracorporeal therapies may reduce the consequences of excessive inflammation on vital organs. SeaStar Medical’s novel technologies rely on science and innovation to provide life-saving solutions to critically ill patients. Its extracorporeal therapies 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. For more information visit seastarmedical.com or visit us on LinkedIn or Twitter.