SeaStar Medical Receives $3.6M NIH Grant for Selective Cytopheretic Device Trial

The National Institutes of Health’s (NIH) National Heart, Lung and Blood Institute has awarded SeaStar Medical Holding Corporation a $3.6 million grant to study its extracorporeal therapy solution for kidney replacement therapy systems.

The clinical trial will evaluate the company’s Selective Cytopheretic Device Adult (SCD-ADULT, a member of the Quelimmune product family) as a bridging strategy to left ventricular assist device (LVAD) implantation in patients with chronic heart failure (CHF) who have progressed to acute decompensated heart failure (ADHF). The grant follows a Breakthrough Device Designation for cardiorenal syndrome granted by the U.S. Food and Drug Administration (FDA’s) Center for Biologics Evaluation and Research (CBER) last fall.

With current standard of care treatment, ADHF can accelerate worsening renal function in a feedback loop known as cardiorenal syndrome, which is associated with a poor prognosis. These patients are often ineligible for lifesaving LVAD implantation due to their condition’s severity.
 
The NIH bestowed the grant upon Innovative BioTherapies (IBT), which is led by SCD inventor and SeaStar Medical Scientific Advisor H. David Humes, M.D., a professor within the Division of Nephrology, Internal Medicine, at the University of Michigan. SeaStar Medical will directly receive about one-quarter of the grant for serving as the trial’s contract research organization. The trial is expected to enroll 20 ICU patients with ADHF at four sites who are ineligible for LVAD or cardiac transplantation in order to determine whether the SCD-ADULT can improve these patients’ condition enough so they can eventually undergo LVAD implantation. If successful, this study could lead to a marketing application to the FDA.

“This grant will fund a single clinical trial that could support FDA approval of SCD-ADULT for ADHF,” SeaStar Medical CEO Eric Schlorff said. “We are encouraged by the NIH’s support and appreciate Dr. Humes and his team’s oversight of this trial while we pursue the SCD-ADULT’s approval in adult acute kidney injury and evaluate additional applications in high-value, unmet medical needs where hyperinflammation plays a role.” 

In February, SeaStar Medical announced publication of a manuscript titled “New opportunity for targeting systemic inflammation in patients with heart failure through leucocyte immunomodulation” in the European Journal of Heart Failure (Pitt, B., Iyer, S.P.N. and Humes, H.D.). The manuscript reviews the role of chronic dysregulated systemic inflammation in heart failure and the potential application of SCD-ADULT in enabling previously ineligible patients with severe disease to receive an LVAD or heart transplant. The NIH grant is based upon the first-in-human case study discussed in the manuscript, as well as improved cardiac contractility in a canine model of CHF following treatment with the SCD. Those results were published in the journal PLOS One in April 2023, and also served as the basis for SeaStar Medical’s Breakthrough Device Designation for cardiorenal syndrome.
 
“Several other therapeutic agents tested in large prospective trials of patients with ADHF have demonstrated no clinically relevant efficacy outcomes and often had unacceptable adverse events,” Humes stated. “In contrast, SCD therapy, which immunomodulates activated circulating leukocytes, represents a novel approach to treating cardiorenal syndrome that could address the critical limitation of other therapeutic strategies tested to date.”
 
On Feb. 22, SeaStar Medical announced the Humanitarian Device Exemption (HDE) FDA Approval Order for Quelimmune for use in children weighing 10 kilograms or more with acute kidney injury due to sepsis or a septic condition requiring kidney replacement therapy (KRT). SeaStar Medical also has an ongoing pivotal study evaluating treatment with the SCD in adults in the ICU with acute kidney injury.
 
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.
 
SeaStar Medical’s Selective Cytopheretic Device (SCD) is a patented cell-directed extracorporeal device that employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during continuous KRT (CKRT) and reduces the hyperinflammatory milieu including the cytokine storm that causes inflammation, organ failure, and possible death in critically ill patients. Unlike pathogen removal and other blood-purification tools, the device is integrated with CKRT hemofiltration systems to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. The SCD selectively targets the most highly activated proinflammatory neutrophils and monocytes. These cells are then returned back into the body through the blood, and the body is signaled to lower its inflammatory environment and focus on repair. This immunomodulation approach may promote long-term organ recovery and eliminate the need for future KRT, including dialysis. At this time Quelimmune is specifically branded for pediatric acute kidney injury (AKI).
 
IBT is a privately held biotechnology company founded to facilitate the commercialization of technology developed in Humes’ academic laboratory. IBT’s research and development program is primarily supported by federal grants and contracts that focus on developing cell therapy devices utilizing human progenitor cells, biomimetic materials, and micro-electromechanical systems (MEMs) technology. 
 
SeaStar Medical is a medical technology company developing extracorporeal therapies to reduce the consequences of excessive inflammation on vital organs. 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.