Extracorporeal Immunomodulation Therapy in Acute Chronic Liver Failure With Multiorgan Failure: First in Human Use.

Area of Science:

• Hepatology
• Immunology
• Critical Care Medicine

Background:

• Acute on chronic liver failure (ACLF) is characterized by hyperinflammation and multiorgan failure, leading to high mortality rates.
• Hepatorenal syndrome (HRS) is a common complication in ACLF, further worsening prognosis.
• Existing treatments for ACLF with HRS have limited efficacy and high mortality.

Purpose of the Study:

• To evaluate the safety and efficacy of a novel extracorporeal cell-directed immunomodulatory device in patients with ACLF and HRS.
• To assess the impact of the selective cytopheretic device on inflammatory markers and clinical outcomes in ACLF patients.

Main Methods:

• Two patients with ACLF and HRS were treated under an FDA-approved Investigational Device Exemption clinical trial.
• Treatment involved extracorporeal therapy using a selective cytopheretic device, designed to modulate immune cell activity.
• Cytokine concentrations and leukocyte activation levels were monitored throughout the treatment course.

Main Results:

• Both patients demonstrated rapid clinical improvement following treatment with the selective cytopheretic device.
• A significant decline in elevated blood cytokine levels and reduced activation of circulating leukocytes were observed.
• One patient was alive at 90 days and awaiting liver transplant evaluation; the other successfully underwent liver transplantation 6 days post-therapy.

Conclusions:

• This study represents the first in-human evaluation of extracorporeal cell-directed immunomodulation for ACLF with HRS.
• The selective cytopheretic device shows potential as a novel therapeutic option for ACLF, offering successful clinical outcomes in a high-mortality condition.
• Further research is warranted to confirm these findings in larger patient cohorts.