SeaStar Medical is progressing its pivotal trial evaluating the usage of its Selective Cytopheretic System (SCD) in sufferers with acute kidney damage (AKI), with the corporate saying that 12 sufferers have now been enrolled.
The NEUTRALISE-AKI pivotal medical trial (NCT05758077) is predicted to enrol as much as 200 sufferers with AKI who require steady kidney substitute remedy (CKRT).
SeaStar Medical’s chief medical officer Kevin Chung stated that the corporate has enrolled 5 sufferers over the previous six weeks, in addition to activating further medical websites, based on a 28 December press launch.
There are 30 research websites within the US anticipated for the trial, as per ClinicalTrials.gov. 5 of those are at present within the recruiting stage. The trial enrolled its first patient in June 2023.
SCD is a sort of cell-directed extracorporeal remedy delivered by way of CKRT. It really works by selectively focusing on and neutralising neutrophils and monocytes – effector cells that play a key position in hyperinflammation. The neutralised cells are then returned again into the physique via the blood. Usually, the overactivity of the immune system can result in organ injury and may even result in multi-organ failure.
SeaStar’s SCD machine was granted breakthrough device designation by the US Meals and Drug Administration (FDA) in October 2023.
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The corporate expects to obtain FDA approval beneath a Humanitarian System Exemption (HDE) to be used in youngsters weighing 10 kilograms or extra with AKI and sepsis. Kids with a septic situation requiring steady CKRT anytime throughout the subsequent 30 to 45 days may even be indicated. In October 2023, the corporate obtained correspondence from the FDA signalling the machine to be approvable beneath HDE.
The machine’s rollout is predicted in Q1 2024, based on SeaStar.
The NEUTRALISE-AKI research’s main endpoint is a composite of 90-day mortality or dialysis dependency of sufferers handled with SCD. Sufferers receiving remedy with the SCD along with CKRT will probably be in comparison with sufferers within the management group solely receiving CKRT customary of care. A subgroup evaluation may even discover the potential effectiveness of SCD remedy in AKI sufferers with sepsis and acute respiratory misery syndrome.