Selective Cytopheretic Device for Cardiorenal Syndrome

(NEUTRALIZE-CRS Trial)

Overseen By Angela Westover, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SeaStar Medical

Must be taking: Beta blockers, ACE inhibitors

Must not be taking: Vasopressors, Vasoconstricting inotropes

Disqualifiers: Bacteremia, Metastatic malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 days

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants should have failed to respond to optimal medical therapy, which includes certain heart failure medications, for 45 of the last 60 days. It's best to discuss your specific medications with the trial team.

How is the Selective Cytopheretic Device treatment different from other treatments for cardiorenal syndrome?

The Selective Cytopheretic Device is unique because it uses an extracorporeal (outside the body) process to selectively remove specific immune cells from the blood, which is different from traditional drug therapies that often involve medication. This approach is similar to other apheresis techniques used in different conditions, but it is specifically designed to target immune cells that contribute to inflammation in cardiorenal syndrome. ^{1 2 3 4 5}

What is the purpose of this trial?

Cardiovascular disease is the leading cause of mortality in the US, accounting for 45% of all deaths. Chronic Heart Failure (CHF) is now understood to be a multi-system disease process involving not only the cardiovascular system but also the renal, neuroendocrine, and immune systems. No effective therapy is currently available to treat the most severe subset of CHF patients that have progressed to acute decompensated HF. An innovative approach to reduce the cardio-depressant effects associated with the chronic inflammatory state of CHF may provide a breakthrough for this disorder. This proposal will evaluate the safety and probable benefit to improve cardiac or renal function with an immunomodulatory device to bridge patients to Left Ventricular Assist Device (LVAD) implantation who were previously deemed ineligible for this life sustaining procedure. The Selective Cytopheretic Device (SCD) is an immuno-regulating, extracorporeal membrane device targeted to modulate the cardiodepressant effects assocaited with CHF. SCD is a platform technology focused on immunomodulation of acute and chronic inflammation associated with acute and chronic organ dysfunction. SCD membranes selectively sequester activated systemic leukocytes as they flow through the cartridge via an extracorporeal circuit. Pre-clinical results show that SCD treatment results in a 25% improvement in ejection fraction in a canine CHF model. This study will enroll 20 patients across 5 clinical sites to evaluate the safety and initial efficacy data of SCD treatment in this indication. Patients will receive 4-hour daily SCD treatment for 6 days, followed by 6 months of follow up.

Research Team

Keith Aaronson, MD

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for patients with severe chronic heart failure who haven't improved with standard treatments. They must have a left ventricular ejection fraction of ≤25% or ≤35%, depending on their treatment goal, and be in NYHA class IIIB or IV. Participants need to have an eGFR (a measure of kidney function) ≥40 ml/min/1.73 m2 and can't exercise due to their condition.

Inclusion Criteria

Central venous pressure/Pulmonary wedge pressure >0.65

Right ventricular stroke work index < 300 mmHg * ml/m2

Pulmonary artery pulsatility index (PAPi) < 2

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 4-hour daily SCD treatment for 6 days

6 days

Daily visits for treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Selective Cytopheretic Device

Trial Overview The study tests the Selective Cytopheretic Device (SCD), which aims to modulate inflammation related to chronic heart failure, potentially improving cardiac or renal function. It's for those ineligible for LVAD implantation, involving daily 4-hour SCD treatments over six days with a follow-up period of six months.

Participant Groups

Group I: Selective Cytopheretic Device Experimental Treatment 1 Intervention

Selective Cytopheretic Device is already approved in United States for the following indications:

Approved in United States as QUELIMMUNE for:

• Acute kidney injury (AKI) due to sepsis or a septic condition on antibiotic therapy and requiring renal replacement therapy (RRT) in pediatric patients (weight ≥10kg and age ≤22 years)
• Chronic systemic inflammation in end-stage renal disease (ESRD) patients who require chronic hemodialysis

Who Is Running the Clinical Trial?

SeaStar Medical

Lead Sponsor

Trials

6

Recruited

690+

Lenar Yessayan

Lead Sponsor

Trials

3

Recruited

40+

Keith Aaronson, MD

Lead Sponsor

Trials

2

Recruited

30+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Innovative BioTherapies (IBT)

Industry Sponsor

Trials

1

Recruited

20+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Pilot clinical study of Adacolumn cytapheresis in patients with systemic lupus erythematosus. [2018]

2. Italy pubmed.ncbi.nlm.nih.gov

[Is apheresis still a useful tool in the treatment of nephrological diseases?] [2019]

3. Denmark pubmed.ncbi.nlm.nih.gov

[Use of adsorption methods for plasma component apheresis]. [2006]

4. United States pubmed.ncbi.nlm.nih.gov

State of the art of lipid apheresis. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Plasmapheresis in immunologic renal disease. [2022]