Seastar Medical Holding Corporation has resolved supply chain concerns that impacted the sourcing of a component (tubing connectors) for the selective cytopheretic device (SCD).
Following this, the company enrolled the first patient in the pivotal trial investigating the SCD device in combination with continuous kidney replacement therapy (CKRT) in critically ill patients with acute kidney injury (AKI).
SCD is a cell-directed extracorporeal therapy delivered via CKRT, selectively targeting and neutralising pro-inflammatory neutrophils and monocytes to restore homeostasis.
The multicentre, randomised NEUTRALIZE-AKI trial (NCT05758077) evaluates if up to ten sequential 24-hour treatments with SCD and CKRT improve survival in patients with AKI in the intensive care unit (ICU) setting, compared to the standard CKRT.
The primary endpoint for the study is composite mortality or dialysis dependence (need for any kidney replacement therapy) at 90 days. The secondary endpoints include major adverse kidney events at 90 days, dialysis dependence at one year, number of days requiring ICU care within the 28-day period, and mortality rate 28 days after randomisation.
SeaStar Medical chief medical officer Kevin Chung stated: “Nearly two dozen hospitals and academic centres 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 enrolment very soon.”
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The trial is expected to enrol 200 participants across multiple US sites. As per trial registration, SeaStar’s clinical site in Corvallis, Oregon, has commenced patient recruitment for the NEUTRALIZE-AKI trial.
Last year, SeaStar Medical merged with LMF Acquisition Opportunities to become a publicly listed company. The company signed a US marketing and distribution agreement of SCD with Nuwellis for AKI in children in January 2023.
Data on the use of SCD in the paediatric population was first published in 2020.