INTRODUCING QUELIMMUNE
The Selective Cytopheretic Device - Pediatric (SCD-PED)
What is QUELIMMUNE?
QUELIMMUNE, also known as the Selective Cytopheretic Device for Pediatrics (SCD-PED), is a humanitarian medical device to treat pediatric patients with acute kidney injury (AKI) due to sepsis or a septic condition. The device is connected in-line to an existing hemodialysis delivery system’s extracorporeal continuous kidney replacement therapy (CKRT) circuit.
QUELIMMUNE was granted approval under a Humanitarian Device Exemption (HDE) by FDA in February 2024 with clinical data establishing safety and probable benefit for this use. See Clinical Studies section below.
Rx Only
INDICATION FOR USE
QUELIMMUNE (SCD-PED) is intended to treat pediatric patients (weight ≥ 10 kg and age ≤ 22 years) with acute kidney injury (AKI) due to sepsis or a septic condition on antibiotic therapy and requiring renal replacement therapy (RRT).
Clinical Studies of the SCD-PED
QUELIMMUNE was evaluated in two multi-center, open-label, prospective clinical trials (SCD-PED-01 & SCD-PED-02) in pediatric intensive care unit (ICU) patients with AKI requiring CKRT.
QUELIMMUNE therapy demonstrated safety & probable benefit in this critically ill population.
Study Design & Endpoints:
Safety Results:
Secondary Outcomes:
QUELIMMUNE (SCD-PED) therapy demonstrated:
– 77% survival rate at Day 60
– No dialysis required in survivors (Day 60 after ICU discharge)
– 87.5% of survivors had normal kidney function (Day 60 after ICU discharge)
These data were published in the journal Kidney Medicine (2).
QUELIMMUNE Can Be Efficiently Added to Existing Workflows
CONTRAINDICATIONS
Use of the SCD-PED as a standalone unit to provide any renal replacement therapy or fluid and electrolyte management therapy is contraindicated.
The SCD-PED cartridge and SCD Blood Tubing Set should not be used on patients who have a known allergy to any components in this product.
ADVERSE REACTIONS
Five adverse reactions were observed in more than one instance across the two pediatric SCD studies (SCD-PED-01 [16 subjects enrolled] and SCD-PED-02 [6 subjects enrolled]). Those adverse reactions include six instances of hypotension across three subjects, four instances of hypothermia across two subjects, four instances of tachycardia across three subjects, two instances of hyperglycemia across two subjects, and two instances of thrombocytopenia across two subjects.
Pathogenic and mechanical triggers of a cytokine storm
VIRAL INFECTION
Examples:
SARS-CoV-2, influenza A, dengue virus
BACTERIAL INFECTION
Examples:
Staphylococcus aureus, Escherichia coli, Francisella tularensis
TRAUMA
Examples:
Acute lung injury, acute kidney injury, hemorrhagic shock
SURGERY
Examples:
Surgical AKI, invasive surgery, tissue injury, septic shock
Through organ crosstalk, damaged organs can cause further destruction to other organs (as illustrated by arrows). Note: These are not all the possible morbidities associated with the cytokine storm.
read more about the pediatric clinical studies here:
References:
- Goldstein SL, et al. Use of the selective cytopheretic device in critically ill children. Kidney Int Rep. 2020 Dec 19;6(3):775-84.
- Goldstein SL, et al. Selective cytopheretic device use in continuous kidney replacement therapy in children: A cohort study with a historical comparator. Kidney Medicine. 2024 Article in press. Published February 15, 2024.
- Goldstein SL, et al. Pediatric patients with multi-organ dysfunction syndrome receiving continuous renal replacement therapy. Kidney International. 2005 Feb;67(2):653-8.
Looking for more information on QUELIMMUNE? Contact us:
Telephone: 844-427-8100
Email: info@seastarmed.com