protocolSection identificationModule nctId: NCT06285253, orgStudyIdInfo id: MIRO-01-001, briefTitle: miroliverELAP® for the Treatment of Acute Liver Failure: A Phase 1 Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-02-28, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Miromatrix Medical Inc., class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Acute Liver Failure, conditions: Acute Liver Injury, Drug Induced, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single arm, open label, safety study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: miroliverELAP treatment, outcomesModule primaryOutcomes measure: Survival, primaryOutcomes measure: Adverse Events, secondaryOutcomes measure: 21-day survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California San Francisco Medical Center, city: San Francisco, state: California, zip: 94143, country: United States, contacts name: Bilal Hameed, MD, role: CONTACT, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Emory University School of Medicine, city: Atlanta, state: Georgia, zip: 30322, country: United States, geoPoint lat: 33.749, lon: -84.38798, locations facility: Northwestern Memorial Hospital, city: Chicago, state: Illinois, zip: 60611, country: United States, contacts name: Justin Boike, MD, role: CONTACT, geoPoint lat: 41.85003, lon: -87.65005, locations facility: University of Michigan Medical School, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, contacts name: Lena Napolitano, MD, role: CONTACT, geoPoint lat: 42.27756, lon: -83.74088, locations facility: University of Minnesota Medical School, city: Minneapolis, state: Minnesota, zip: 55455, country: United States, contacts name: Thomas Leventhal, MD, role: CONTACT, geoPoint lat: 44.97997, lon: -93.26384, locations facility: Mayo Clinic, city: Rochester, state: Minnesota, zip: 55902, country: United States, geoPoint lat: 44.02163, lon: -92.4699, locations facility: Mount Sinai Recanati/Miller Transplantation Institute, city: New York, state: New York, zip: 10029, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Cleveland Clinic Foundation, city: Cleveland, state: Ohio, zip: 44195, country: United States, geoPoint lat: 41.4995, lon: -81.69541, locations facility: Intermountain Healthcare, city: Salt Lake City, state: Utah, zip: 84103, country: United States, contacts name: Richard Gilroy, MD, role: CONTACT, geoPoint lat: 40.76078, lon: -111.89105, locations facility: Virginia Commonwealth University Medical Center, city: Richmond, state: Virginia, zip: 23970, country: United States, geoPoint lat: 37.55376, lon: -77.46026, hasResults: False