SeaStar Medical Holding has announced the publication of early post-approval clinical experience from the use of the Quelimmune therapy in the journal Pediatric Nephrology.
The publication highlights early experience from the SAVE registry, a post-approval surveillance registry, evaluating the role of the Quelimmune therapy in the treatment of critically ill paediatric patients with life-threatening acute kidney injury (AKI) and sepsis requiring renal replacement therapy.
Observations from the first 21 paediatric patients with AKI and sepsis requiring renal replacement therapy showed no device-related adverse events or infections and no reports of immunosuppressive effects by the device.
In addition, preliminary outcomes analyses show a 76% survival rate at day 28 and day 60, and a 71% survival rate at day 90. These new data are on track to validate a 50% reduction in patient mortality at 60 days compared to historical data, similar to what was observed in the registration study reported in Kidney Medicine.
Additional analyses included survival of patients requiring extracorporeal membrane oxygenation (ECMO) and independence from renal replacement therapy for paediatric patients without a history of end-stage renal disease or a recent kidney transplant. The evaluation of five patients concomitantly treated with the Quelimmune therapy and ECMO showed a 60% survival rate at day 90. Among paediatric patient survivors without a history of end-stage renal disease or a recent kidney transplant, 75% (nine of 12) and 83% (10 of 12) were dialysis free at day 28 and day 90, respectively.
“These real-world experiences of the Quelimmune therapy are compelling for a number of reasons,” stated Stuart Goldstein, director of the Center for Acute Care Nephrology at Cincinnati Children’s Hospital (Cincinnati, USA) and a member of the SeaStar Medical scientific advisory board. “First, they mirror the results from the two registrational trials that enabled FDA [US Food and Drug Administration] approval of the therapy in critically ill patients with AKI and sepsis requiring renal replacement therapy, further demonstrating the reproducibility of the therapeutic benefit. Second, the complexity of the patient population with respect to their comorbidities show a much broader array of use compared to the narrower patient selection in the registrational trials. And finally, with no device-related serious adverse events to date, I believe there is a clear potential benefit from the Quelimmune therapy with minimal downside risk to patient safety. For these reasons, we have had the Quelimmune therapy available since FDA approval for our patients who present with such life-threatening conditions.”
The SAVE registry is a post-approval study that is designed to collect additional safety and other clinical effectiveness data of the Quelimmune therapy in the treatment of paediatric patients with AKI and sepsis requiring renal replacement therapy. FDA initially required the enrolment of 300 patients in the SAVE registry. After submission of data to the FDA from the first 21 patients and discussion between SeaStar Medical and the Agency, FDA reduced its mandated target from 300 to 50 patients. Medical institutions employing the Quelimmune therapy will continue to collect data for up to the first 50 patients treated with Quelimmune.
Specific outcomes data will include 28-day safety, and 90-day survival and dialysis dependency with plans to compare the SAVE registry data to an existing control group of patients with similar illness severity.
