Study met primary and secondary endpoints related to survival and renal recovery at day 60.
DENVER, Oct. 26, 2020 /PRNewswire/ — SeaStar Medical, a medical technology company delivering novel therapeutic immunomodulating solutions to improve organ function, today announced the results from the first every application of the Selective Cytopheretic Device (SCD) in pediatric patients with acute kidney injury (AKI) requiring continuous renal replacement therapy (CRRT).
The study’s primary objective was to assess the safety of the SCD in children. Safety was determined by adverse events related to treatment up to 60 days following treatment initiation. Secondary outcome measures were mortality and renal replacement therapy dependency at day 60. The study met its endpoints of safety and reduced mortality and dialysis dependence at day 60. The data show:
- No SCD related adverse events were noted
- 94% of the patients survived SCD therapy
- 75% of the patients survived to ICU discharge
- 100% of ICU survivors were dialysis independent and had normal kidney function at 60 days
Pediatric AKI requiring CRRT is rare, with less than 4,000 cases reported in the U.S. each year and is associated with high morbidity and mortality. The mortality rate in children with AKI requiring CRRT is approximately 50 percent. Children who survive an AKI episode are at risk of long-term conditions, including chronic kidney disease (CKD).
SCD-PED-01 Pilot Study (NCT02820350) Design
This open-label, multi-center pilot study assessed the safety and feasibility of the SCD in pediatric patients with AKI and multi-organ dysfunction (MOD) requiring CRRT. The U.S. Food and Drug Administration (FDA) funded study enrolled 16 participants across four U.S. clinical sites, meeting the FDA target. The study’s participants ranged from 4 to 21 years of age. The group was equally split between males and females.
Provision of the SCD therapy did not require substantial technical alteration to standard CRRT therapy in children. The SCD was integrated post CRRT membrane and changed daily. Regional citrate coagulation was used to achieve a circuit iCa2+ <0.40 mmol/L. The patients received SCD treatment for up to 7 days or CRRT discontinuation, whichever came first.
“There are very few therapeutic options available to treat pediatric AKI. While more research is needed to establish its efficacy, these positive results suggest a favorable benefit to risk ratio in the critically ill pediatric population,” said Stuart L. Goldstein, MD of Cincinnati Children’s Hospital Medical Center and the principal investigator of the pediatric study.
The immunodulating SCD device works with CRRT systems to selectively target and transition activated neutrophils to a less inflammatory state as well as pro-inflammatory monocytes to reparative functionality. It has been previously tested in adults, including a Phase III Investigational Device Exemption (IDE) randomized controlled, multi-center trial that demonstrated the effectiveness of the SCD therapy to reduce mortality and dialysis dependency in adults with AKI and MOD requiring CRRT 60 days after treatment. The promising results of this study prompted a grant from the FDA Orphan Products Development office to study the SCD in pediatric patients. Based on the findings, the FDA has granted the designation of Humanitarian Use Device (HUD) for the SCD, and SeaStar Medical is now in the application phase for the Humanitarian Device Exemption (HDE) for pediatric use.
“Fighting the consequences of inflammation in organs has immediate and broad applications. When in overproduction inflammation can cause lasting and even fatal damage to the body. The pediatric SCD data show the SCD is safe to use in pediatric patients, which may provide new options for treating a variety of rare, inflammatory response injuries in children. This could be game-changer for critically ill children,” said Eric Schlorff, Chief Executive Officer of SeaStar Medical.
About the Selective Cytopheretic Device (SCD)
The Selective Cytopheretic Device (SCD) is a medical device that employs immunomodulating technology to selectively target pro-inflammatory neutrophils and monocytes during CRRT and remove the cytokine storm that causes inflammation, organ failure, and possible death in critically ill patients. The device works with hemofiltration systems to enable precise fluid and solute balance control to selectively target and transition pro-inflammatory monocytes to reparative and promote activated neutrophils to be less inflammatory. This unique immunomodulation approach may reverse injury and eliminate the need for CRRT going forward.
SeaStar Medical has received the designation of a Humanitarian Use Device (HUD) for use of the SCD in adults.
About SeaStar Medical
Denver-based SeaStar Medical is a privately held medical device company that has redefined how extracorporeal therapies may reduce the consequences of excessive inflammation on vital organs through novel solutions and services. SeaStar Medical’s focus is on removing pro-inflammatory mediators, known as cytokines, or transforming key immune system messengers from pro-inflammatory to reparative physiology. SeaStar Medical’s next-generation technologies rely on science and innovation to build upon existing purification technologies to provide life-saving solutions to critically ill patients. For more information visit seastarmedical.com or visit us on LinkedIn.
SOURCE SeaStar Medical