October 26, 2020
Selective Cytopheretic Device study in pediatric patients with acute kidney injury was reported as positive reports SeaStar Medical.
Selective Cytopheretic Device study’s primary objective was to assess the safety of the device 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.