A Phase 1 Prospective Study of the Miromatrix External Liver Assist Product (miroliverELAP®) for Liver Support in Adults With Acute Liver Failure.
The clinical trial will assess the safety of miroliverELAP for the treatment of acute liver failure, severe acute alcohol-associated hepatitis, or acute on chronic liver failure. miroliverELAP is an external liver assist combination product consisting of a single-use MIRO-001 bioengineered liver graft and an extracorporeal blood circuit. miroliverELAP Is intended to support the native (failed) liver for up to 48-hours of continuous treatment to allow time for liver recovery or to identify a transplantable liver.
• 18 years to 80 years old at the time of signing the informed consent
• Subject must:
‣ be deemed competent to consent by an independent qualified practitioner, or
⁃ have consent given by a Legally Authorized Representative
• Subject should be in the intensive care unit
• Be diagnosed with 4.1. Acute Liver Failure defined as:
‣ INR ≥ 2.0, and
⁃ Hepatic Encephalopathy Grade II-III (West Haven Criteria), and
⁃ Less than 4 weeks (28 days) of disease duration 4.2. Severe Acute Alcohol-Associated Hepatitis as defined as:
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‣ Hepatic Encephalopathy Grade I-III (West Haven Criteria), and
⁃ Model for End-Stage Liver Disease (MELD) Score ≥ 20, and
⁃ INR ≥ 2.0, and
⁃ No overt evidence of cirrhosis 4.3. Acute on Chronic Liver Failure:
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‣ Hepatic Encephalopathy Grade I-III (West Haven Criteria), and
⁃ Model for End-Stage Liver Disease (MELD) Score ≥ 20, and
⁃ INR ≥ 2.0,
‣ 5\. Subject is not a candidate for liver transplant and will not become a candidate in the event of worsening conditions.