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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new device designed to assist individuals with severe chronic heart failure (CHF) who also have kidney issues. The Selective Cytopheretic Device (SCD) operates outside the body to reduce inflammation, potentially improving heart and kidney function. The trial seeks participants hospitalized for heart failure who might require a Left Ventricular Assist Device (LVAD) but have been ineligible due to their condition. Ideal candidates experience worsening heart and kidney function, with symptoms such as swelling and difficulty breathing, despite standard medications. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new treatment options.

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.

What prior data suggests that the Selective Cytopheretic Device is safe for treating cardiorenal syndrome?

Research has shown that the Selective Cytopheretic Device (SCD) is generally safe for people. The FDA has approved the device for treating a serious kidney condition, indicating it meets safety standards for human use.

Studies have found that the SCD can be safely used alongside current kidney treatments, suggesting it might be a safe option for patients with both heart and kidney problems. No major safety issues have been reported in these cases.

In summary, while more research is needed to confirm its safety for heart failure, the SCD has demonstrated a good safety record in other treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Selective Cytopheretic Device (SCD) because it offers a novel approach to treating cardiorenal syndrome, a condition where heart and kidney dysfunctions exacerbate each other. Unlike traditional treatments, which primarily focus on managing symptoms with medications like diuretics or ACE inhibitors, the SCD targets the inflammatory response directly. This device works by selectively filtering and modulating activated white blood cells, potentially reducing inflammation and improving both heart and kidney functions. If successful, the SCD could provide a more targeted and effective treatment option, offering hope for better patient outcomes.

What evidence suggests that the Selective Cytopheretic Device is effective for cardiorenal syndrome?

Research has shown that the Selective Cytopheretic Device (SCD), which participants in this trial will receive, can help manage heart failure by calming over-active immune cells. In a study with dogs that had chronic heart failure, SCD treatment improved heart function by 25%, specifically enhancing the heart's ability to pump blood. Early human studies also show promising results, with 76% of participants surviving at both Day 28 and Day 60, and 71% surviving at Day 90. The device may also lower death rates in similar treatments, indicating a positive impact on patient outcomes. In studies with children, 77% of those treated with SCD survived, exceeding expectations. These findings suggest that SCD could be a breakthrough for patients with severe heart failure affecting the kidneys and other systems. ^{2 4 6 7 8}

Who Is on the Research Team?

Keith Aaronson, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. investors.seastarmedical.com investors.seastarmedical.com/news-releases/news-release-details/seastar-medical-reports-positive-early-results-quelimmune

Release Details In addition, outcomes analyses show a 76% survival rate at Day 28 and Day 60, and a 71% survival rate at Day 90. These new data are on track to ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40847756/

Projected hospitalization cost impact of the selective ... The SCD-PED is likely cost-beneficial in critically ill children with AKI requiring CRRT, including those with sepsis.

3. finance.yahoo.com finance.yahoo.com/news/seastar-medical-present-early-save-122300722.html

SeaStar Medical to Present Early SAVE Registry Data of ... The Selective Cytopheretic Device (SCD) therapy is designed as a disease-modifying device that neutralizes over-active immune cells and ...

4. renalinterventions.net renalinterventions.net/first-data-from-save-registry-on-track-to-validate-use-of-quelimmune-in-treatment-of-paediatric-aki/

First data from SAVE registry on track to validate use of ... These new data are on track to validate or potentially exceed a 50% reduction in loss of life compared to historical data, as reported in Kidney ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2590059524000037

Selective Cytopheretic Device Use in Continuous Kidney ... Twenty-two children received treatment with the SCD put in line with a standard dialysis machine, of which 17 (77%) survived (compared to the expected 11).

6. investors.seastarmedical.com investors.seastarmedical.com/node/9056/pdf

SeaStar Medical Reports Positive Results for ... It is the only FDA approved product for the ultra-rare condition of life-threatening acute kidney injury (AKI) due to sepsis or a septic ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03836482

Feasibility of the SCD in Cardiorenal Syndrome Patients ... 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 ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10589552/

Safety Summary of the Selective Cytopheretic Device The SCD is a promising immunomodulatory extracorporeal therapy that can be safely added to existing continuous kidney replacement therapy circuits.