United Therapeutics Corporation and Intermountain Health announced a historic medical breakthrough with the world's first patient treatment using miroliverELAP, a bioengineered external liver assist device. The procedure, performed at Intermountain Medical Center in Murray, Utah, represents the first human clinical trial of a manufactured organ alternative and offers new hope for patients with acute liver failure who are not eligible for liver transplantation.
The groundbreaking treatment was administered to a patient experiencing liver failure under the leadership of Christopher J. Danford, MD, a transplant hepatologist at Intermountain Health. This milestone marks a significant advancement in addressing the critical shortage of transplantable organs for patients with end-stage organ disease.
Revolutionary Bioengineered Technology
Developed by Miromatrix Medical Inc., a United Therapeutics subsidiary, miroliverELAP is an external liver assist combination product consisting of a single-use MIRO-001 bioengineered liver and an extracorporeal blood circuit. The bioengineered liver utilizes a decellularized porcine liver scaffold to which allogeneic human endothelial and liver cells have been added.
The ELAP system functions as an external perfusion system with a bioengineered liver that resides outside of the human body to provide temporary liver support to patients with acute liver failure. The bioengineered liver is manufactured by recellularizing a decellularized porcine liver with human endothelial cells and human liver cells obtained from donated human livers that were unable to be transplanted.
"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," said Jeff Ross, Ph.D., President of Miromatrix. "We're grateful to the patient and their family, in addition to the scientists and caregivers at Intermountain Health and Intermountain Medical Center who helped make this breakthrough possible."
Addressing Critical Medical Need
Acute liver failure represents a significant medical emergency with devastating outcomes. Approximately 86,000 patients are hospitalized in the U.S. each year with acute forms of liver failure, acute on chronic liver failure and severe acute alcoholic hepatitis, collectively called acute liver failure (ALF). The condition refers to a rapid loss of liver function over days or weeks, often in patients with no history of preexisting liver disease.
Common causes of ALF include hepatitis viruses, drugs such as acetaminophen, and excessive alcohol use. The condition can cause serious complications including excessive bleeding and pressure on the brain, making it a medical emergency requiring immediate hospitalization. Current outcomes for ALF patients are estimated to be 45% spontaneous recovery, 25% liver transplantation and 30% death without transplant.
"Approximately 30% of acute liver failure (ALF) patients die without access to a liver transplant," highlighting the urgent need for alternative treatment options like miroliverELAP.
Clinical Trial Progress
The phase 1 study of miroliverELAP was initiated in 2024 and is currently open for enrollment of patients with ALF at eight sites in the United States. The investigational miroliverELAP system is not approved for any use in any country, and more information about the phase 1 study is available on clinicaltrials.gov.
Ralph Jean-Mary, president of Intermountain Medical Center, emphasized the significance of the achievement: "This groundbreaking procedure – the first of its kind in the world – represents everything Intermountain Health stands for in providing innovative, cutting-edge high-quality care for our patients. We are profoundly thankful to this patient for their participation in this pioneering study, and to our exceptional Intermountain medical team, as well as our partners at United Therapeutics and Miromatrix."
Broader Organ Manufacturing Platform
United Therapeutics' organ and organ alternative manufacturing efforts encompass three platforms – xenotransplantation, allogeneic regenerative medicine, and autologous regenerative medicine – covering four different organs: hearts, kidneys, livers, and lungs. These revolutionary programs are specifically intended to address the ongoing shortage of transplantable organs for patients with end-stage organ disease.
The successful treatment with miroliverELAP represents a significant step forward in the company's mission to develop manufactured organ alternatives. Miromatrix works with organ procurement organizations to obtain donated human livers that were unable to be transplanted, maximizing the utility of available donor organs in the manufacturing process.
