miroliverELAP® for the Treatment of Acute Liver Failure: A Phase 1 Trial
The clinical trail will assess the safety of miroliverELAP for the treatment of acute liver failure without underlying chronic liver disease. 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.
- EligibilityCriteria: Inclusion Criteria:  8 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  Be diagnosed with acute liver failure as defined as:  INR ≥ 2.5, and Hepatic Encephalopathy Grade II-III (West Haven Criteria), and Less than 4 weeks (28 days) of disease duration Subject is not a candidate for liver transplant and will not become a candidate in the event of worsening conditions.  Exclusion Criteria  Underlying chronic liver disease, including:  Acute-on-chronic liver disease Acute alcoholic-associated hepatitis Cirrhosis Grade IV West Haven Encephalopathy Criteria Previous liver transplant Currently requires chronic hemodialysis Uncontrolled- documented infection, hypotension or refractory shock Liver injury due to trauma Any current liver cancer Currently on medications with a narrow therapeutic index, as defined in Section 11.10.1 Platelet count < 40,000 μL If the subject is intubated and has an acute lung injury  Experiencing a bleeding event, defined as:  Active gastrointestinal or other overt bleeding event, or Hemoglobin drop > 3g/dL within the past 24 hours, or Received ≥ 3 units of red blood cell transfusion within the past 24 hours Female that is currently pregnant, planning to be pregnant, or currently breastfeeding Refusal to receive blood products - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult