The first procedure in the world designed to treat a patient using a bioengineered external liver was recently performed by a team at Intermountain Medical Center, led by Dr. Christopher Danford.
Intermountain Health and United Therapeutics, a Minnesota company that owns Miromatrix Medical, which developed the bioengineered liver or miroliverELAP, announced the breakthrough on Tuesday.
The patient treated with the miroliverELAP is experiencing liver failure, but was not eligible for a transplant, a statement from Intermountain on Tuesday said. About 30% of patients with acute liver failure die because they do not have access to a transplant.
The National Institutes of Health clinical trials website explained that in Phase 1, the current phase, at least five patients (and up to 15) will be treated with the device for 48 hours. It is designed to support their failed liver, to give time for either liver recovery or identification of a liver that can be transplanted. Afterward, the patients are treated and monitored for 32 days.
The bioengineered liver gets its scaffolding from a decellularized pig liver that is rebuilt with cells from donated human livers and blood vessel linings. Miromatrix works with organ procurement organizations to utilize livers that were unable to be transplanted, creating the bioengineered liver — miroliverELAP.
Ralph Jean-Mary, president of Intermountain Medical Center, said the “groundbreaking” procedure represents what Intermountain Health stands for — providing patients with innovative, high-quality care.
“This procedure reinforces our unwavering commitment to leading in clinical excellence and helping people live the healthiest lives possible,” he said in a news release.
Jeff Ross, president of Miromatrix, expressed gratitude to the patient and their family, scientists and caregivers who “helped make this breakthrough possible.” He said they are excited to continue with the Phase 1 clinical trial.
“This first-of-its-kind treatment represents a historic achievement for United Therapeutics and Miromatrix in advancing the potential of bioengineered human organs to help save and improve patients’ lives,” he said in the release.
Intermountain Health is one of eight locations recruiting patients for the study. United Therapeutics is also working on manufacturing alternative organs for hearts, kidneys and lungs to address a shortage of transplantable organs.