INTRODUCING QUELIMMUNE

The Selective Cytopheretic Device - Pediatric (SCD-PED)

What is Quelimmune?

Quelimmune, the selective cytopheretic device – pediatric (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).  Quelimmune was granted a Humanitarian Device Exemption (HDE) approval for this indication in February 2024. 

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.  
 

Clinical Studies of the SCD-PED

(see References 1 & 2)

Pooled analyses from two open-label studies, SCD-PED-01 and SCD-PED-02 demonstrated that pediatric patients 10kg with AKI requiring CKRT treated with the Quelimmune pediatric device had no device-related serious adverse events or device-related infections, nor thrombocytopenia or immunosuppression.  The PED-01 (weight range 15 kg) and PED-02 (weight range 10 kg) studies demonstrated 75% and 83% survival rates with the use of the SCD-PED, respectively.  The pooled cohort of patients exhibited an overall survival rate of 77% [vs. 55% in the comparator registry (3)] and no dialysis dependency at Day 60.   These data were recently published in the journal Kidney Medicine (2)

The SCD-PED added to Standard of Care Renal Replacement Therapy

Figure created with BioRender

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

VIRAL INFECTION

Examples:
SARS-CoV-2, influenza A, dengue virus

bacterial infection

BACTERIAL INFECTION

Examples:
Staphylococcus aureus, Escherichia coli, Francisella tularensis

trauma

TRAUMA

Examples:
Acute lung injury, acute kidney injury, hemorrhagic shock

surgery

SURGERY

Examples:
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 scd studies here:

References:

  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

Email:  info@seastarmed.com