The Selective Cytopheretic Device - Pediatric (SCD-PED)


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

HUMANITARIAN DEVICE:  Authorized by Federal law for use in the treatment of pediatric patients > 10 kg with acute kidney injury due to sepsis or a septic condition on antibiotic therapy and requiring renal replacement therapy.  The effectiveness of this device for this use has not been demonstrated.   Read Instructions for Use.  Failure to follow Instructions for Use may result in patient harm, injury, or serious adverse reactions.  Additional equipment and supplies are required to use this device.  


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


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. 


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


SARS-CoV-2, influenza A, dengue virus

bacterial infection


Staphylococcus aureus, Escherichia coli, Francisella tularensis



Acute lung injury, acute kidney injury, hemorrhagic shock



Surgical AKI, invasive surgery, tissue injury, septic shock

The cytokine storm can exert its lethal effect by damaging multiple organs, including 10-17:

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:


  1. Goldstein SL, et al. Use of the selective cytopheretic device in critically ill children. Kidney Int Rep. 2020 Dec 19;6(3):775-84.
  2. 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.
  3. 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